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Patient- and Caregiver-reported Symptoms and Outcomes With Levodopa/Carbidopa Intestinal Gel for the Treatment of Advanced Parkinson's Disease (ADEQUA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02289729
Recruitment Status : Completed
First Posted : November 13, 2014
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Parkinson's Disease
Enrollment 62
Recruitment Details  
Pre-assignment Details A total of 62 participants were enrolled; 59 were evaluable and 3 were non-evaluable because they did not participate in the nasoduodenal test phase and they did not receive any dose of levodopa/carbidopa intestinal infusion gel (LCIG).
Arm/Group Title All Participants
Hide Arm/Group Description LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Period Title: Overall Study
Started 59
Completed 53
Not Completed 6
Reason Not Completed
Lack of Efficacy             3
Very Narrow Therapeutic Margin             1
Withdrawal by Subject             1
Death             1
Arm/Group Title All Participants
Hide Arm/Group Description LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
participants who received at least 1 dose of LCIG
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants
67.93  (7.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
23
  39.0%
Male
36
  61.0%
1.Primary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6
Hide Description The PDQ-39 contains 39 items: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (score 0 to 4 on a Likert scale). The global score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.81  (14.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in PDQ-39 Mobility Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The mobility domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-16.92  (24.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in PDQ-39 Activities of Daily Living Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The activities of daily living domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-18.43  (23.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in PDQ-39 Emotional Well-Being Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The emotional well-being domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.06  (19.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline in PDQ-39 Stigma Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The stigma domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.85  (20.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0328
Comments [Not Specified]
Method t-test
Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline in PDQ-39 Social Support Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The social support domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.08  (15.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4183
Comments [Not Specified]
Method t-test
Comments [Not Specified]
7.Primary Outcome
Title Change From Baseline in PDQ-39 Cognition Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The cognition domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.22  (19.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
8.Primary Outcome
Title Change From Baseline in PDQ-39 Communication Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The communication domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.13  (17.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method t-test
Comments [Not Specified]
9.Primary Outcome
Title Change From Baseline in PDQ-39 Bodily Discomfort Domain Score at Month 6
Hide Description The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The bodily discomfort domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.13  (24.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0109
Comments [Not Specified]
Method t-test
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III): Motor Examination at Month 6
Hide Description The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS-III was used in ON state. The motor examination contains 27 items. Each item is scored in a Likert scale from 0 to 4. The UPDRS-III score was calculated summing the score of each item, ranging from 0 to 108, with higher score indicating more impairment.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.51  (11.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the Non-Motor Symptom Scale (NMSS) Global Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The global score was calculated summing the score of each item (severity x frequency), ranging from 0 to 360, with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-35.75  (31.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in NMSS Cardiovascular Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The cardiovascular domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.81  (3.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in NMSS Sleep/Fatigue Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.73  (7.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in NMSS Mood/Cognition Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.83  (13.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0038
Comments [Not Specified]
Method t-test
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.12  (5.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in NMSS Attention/Memory Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.12  (6.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0274
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in NMSS Gastrointestinal Tract Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.58  (5.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in NMSS Urinary Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms.A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.19  (10.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method t-test
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in NMSS Sexual Function Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.94  (6.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in NMSS Miscellaneous Domain Score at Month 6
Hide Description The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.47  (8.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in the Norris/Bond–Lader Visual Analogue Scale (VAS) Mean Global Score at Month 6
Hide Description The Norris/Bond–Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.63  (21.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0297
Comments [Not Specified]
Method t-test
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in the Norris/Bond–Lader Visual Analogue Scale (VAS) Alertness/Sedation Sub-Scale Score at Month 6
Hide Description The Norris/Bond–Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.38  (23.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments [Not Specified]
Method t-test
Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline in the Norris/Bond–Lader Visual Analogue Scale (VAS) Contented/Discontented Sub-Scale Score at Month 6
Hide Description The Norris/Bond–Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.37  (21.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2777
Comments [Not Specified]
Method t-test
Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in the Norris/Bond–Lader Visual Analogue Scale (VAS) Calmness/Relaxation Sub-Scale Score at Month 6
Hide Description The Norris/Bond–Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.58  (27.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method t-test
Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Parkinson Fatigue Scale (PFS-16) at Month 6
Hide Description The PFS-16 comprises 16 items with five polytomous response categories (strongly disagree, disagree, do not agree or disagree, agree, and strongly agree). Responses were scored from 0 (strongly disagree) to 4 (strongly agree), yielding a summed total score ranging from 0 (no fatigue) to 64 (most severe fatigue). The cut-point of ≥ 3.30 was used to identified those perceiving fatigue to be a problem.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.56  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method t-test
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in the Score of the Apathy Scale (AS) to Month 6
Hide Description The AS is an inventory of 14 questions that assess cognitive and behavioral symptoms of emotional apathy. Each is rated from 0 to 3 on a Likert scale. The total scores for AS ranges from 0 (no apathy) to 42 (most apathetic). AS scores ≥ 14 were considered apathetic.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.52  (6.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.5877
Comments [Not Specified]
Method t-test
Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Beck Depression Inventory, Second Edition (BDI-II) at Month 6
Hide Description The BDI-II is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 29-63 indicates severe depression.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.15  (9.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method t-test
Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline in Beck Anxiety Inventory (BAI) at Month 6
Hide Description The BAI is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-7 indicates minimal anxiety, 8-15 indicates mild anxiety, 16-25 indicates moderate anxiety, and 25-63 indicates severe anxiety.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.21  (9.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Composite Score at Month 6
Hide Description The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 5-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total composite score ranging between 0 and 68, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.15  (16.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Undesirable Side Effects at Month 6
Hide Description The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total undesirable side effects score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
-25.00  (39.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Treatment Effectiveness at Month 6
Hide Description The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total treatment effectiveness score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.39  (31.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Convenience of Use at Month 6
Hide Description The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total convenience of use score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.77  (33.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method t-test
Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Impact on Daily Living Activities at Month 6
Hide Description The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total impact on daily living activities score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.75  (30.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
34.Secondary Outcome
Title Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Medical Care at Month 6
Hide Description The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total medical care score ranging between 0 and 8, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.09  (22.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2428
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
35.Secondary Outcome
Title Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Global Satisfaction at Month 6
Hide Description The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total global satisfaction score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
44.44  (32.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0687
Comments [Not Specified]
Method t-test
Comments [Not Specified]
36.Secondary Outcome
Title Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Composite Score at Month 6
Hide Description The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Composite scores range from 0 to 149, with higher scores indicating higher quality of life.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.21  (21.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3126
Comments [Not Specified]
Method t-test
Comments [Not Specified]
37.Secondary Outcome
Title Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Professional Activities at Month 6
Hide Description The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Professional activities scores range from 0 to 38, with higher scores indicating higher quality of life.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.55  (12.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1533
Comments [Not Specified]
Method t-test
Comments [Not Specified]
38.Secondary Outcome
Title Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Social and Leisure Activities at Month 6
Hide Description The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Social and leisure activities scores range from 0 to 58, with higher scores indicating higher quality of life.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.21  (6.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8145
Comments [Not Specified]
Method t-test
Comments [Not Specified]
39.Secondary Outcome
Title Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Caregiving Responsibilities at Month 6
Hide Description The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Caregiving responsibilities scores range from 0 to 53, with higher scores indicating higher quality of life.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.87  (7.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4048
Comments [Not Specified]
Method t-test
Comments [Not Specified]
40.Secondary Outcome
Title Change From Baseline in Zarit Burden Interview (ZBI) at Month 6
Hide Description The ZBI is a 22-item questionnaire in which caregivers must evaluate the level of agreement on a 5-point Likert scale from 0 to 4. The total score is obtained by the sum of the scores of the items. This total score represents a level of caregiver burden, with a range of 0 indicating no burden to 88 indicating completely overloaded.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.32  (10.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8321
Comments [Not Specified]
Method t-test
Comments [Not Specified]
41.Secondary Outcome
Title Change From Baseline in the Caregiver Stress Index (CSI) at Month 6
Hide Description The CSI is a 13-item questionnaire based on identified common stressors. Answers are in yes/no format. Scoring is 1 point for each “yes” and 0 for each “no”. The total score is obtained by the sum of the scores of the items. Minimum score is 0 (no stress) and maximum score is 13 (most stress). A score ≥ 7 indicates a high level of stress.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.55  (2.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1945
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
42.Secondary Outcome
Title Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Depression Sub-Scale for Caregivers at Month 6
Hide Description The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each “yes” and 0 for each “no”, with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.20  (2.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7937
Comments [Not Specified]
Method t-test
Comments [Not Specified]
43.Secondary Outcome
Title Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Anxiety Sub-Scale for Caregivers at Month 6
Hide Description The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each “yes” and 0 for each “no”, with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.10  (0.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0234
Comments [Not Specified]
Method signed-rank test
Comments [Not Specified]
44.Secondary Outcome
Title Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) at Month 6
Hide Description Absenteeism, presented as the mean percentage of work time missed due to caregiving (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to caregiving / (number of hours of work missed due to caregiving + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percentage of work time missed
-7.56  (40.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5922
Comments [Not Specified]
Method t-test
Comments [Not Specified]
45.Secondary Outcome
Title Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Caregiving (Presenteeism)
Hide Description Presenteeism (the extent to which caregiving decreased productivity) is presented as the mean percentage of impairment while working due to caregiving, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percentage of work impairment
0.00  (18.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method t-test
Comments [Not Specified]
46.Secondary Outcome
Title Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to Caregiving
Hide Description The mean percentage of OWPI due to caregiving (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which caregiving decreased productivity (%)* [number of hours worked / (number of hours of work missed due to caregiving + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percentage of overall work impairment
-6.69  (42.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6481
Comments [Not Specified]
Method t-test
Comments [Not Specified]
47.Secondary Outcome
Title Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Caregiving
Hide Description Activity impairment due to caregiving (the extent to which caregiving affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity/activity and 100% representing complete impact on productivity/activity.
Time Frame Baseline, Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percentage of activity impairment
-3.33  (22.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6741
Comments [Not Specified]
Method t-test
Comments [Not Specified]
48.Secondary Outcome
Title Correlation Between Participants’ Quality of Life (PDQ-39) and Different Questionnaires at Baseline
Hide Description

Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for “yes” and 0 for “no.” The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline assessments.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: correlation coefficient
PDQ-39 with UPDRS-III Number Analyzed 58 participants
0.27148
PDQ-39 with UPDRS-IV Number Analyzed 58 participants
0.07346
PDQ-39 with NMSS Number Analyzed 58 participants
0.20994
PDQ-39 with BAI Number Analyzed 58 participants
0.28271
PDQ-39 with BDI-II Number Analyzed 58 participants
0.46174
PDQ-39 with AS Number Analyzed 57 participants
0.08846
PDQ-39 with PFS Number Analyzed 57 participants
0.33361
PDQ-39 with NBL A-S Number Analyzed 57 participants
0.22085
PDQ-39 with NBL C-D Number Analyzed 57 participants
0.35742
PDQ-39 with NBL C-R Number Analyzed 57 participants
0.00011
PDQ-39 with ZBI Number Analyzed 54 participants
-0.35125
PDQ-39 with GADS-Anxiety Number Analyzed 54 participants
0.21311
PDQ-39 with GADS-Depression Number Analyzed 28 participants
0.51846
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with UPDRS-III
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0389
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.27846
Confidence Interval (2-Sided) 95%
0.014175 to 0.495059
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with UPDRS-IV
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5852
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.07359
Confidence Interval (2-Sided) 95%
-0.188409 to 0.325580
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NMSS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1140
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.21311
Confidence Interval (2-Sided) 95%
-0.051127 to 0.444152
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with BAI
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0311
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.29062
Confidence Interval (2-Sided) 95%
0.026334 to 0.504186
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with BDI-II
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.49952
Confidence Interval (2-Sided) 95%
0.230995 to 0.643312
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with AS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5146
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.08869
Confidence Interval (2-Sided) 95%
-0.176169 to 0.341163
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with PFS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0108
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.34688
Confidence Interval (2-Sided) 95%
0.079996 to 0.546657
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NBL A-S
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0989
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.22455
Confidence Interval (2-Sided) 95%
-0.042139 to 0.455224
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NBL C-D
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0060
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.35742
Confidence Interval (2-Sided) 95%
0.106797 to 0.565335
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NBL C-R
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9993
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.00011
Confidence Interval (2-Sided) 95%
-0.260462 to 0.260673
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with ZBI
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0088
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.36687
Confidence Interval (2-Sided) 95%
-0.565795 to -0.092154
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with Goldberg-Anxiety
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1222
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.21643
Confidence Interval (2-Sided) 95%
-0.057959 to 0.454911
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with Goldberg-Depression
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.57423
Confidence Interval (2-Sided) 95%
0.180247 to 0.747040
Estimation Comments [Not Specified]
49.Secondary Outcome
Title Correlation Between Participants’ Quality of Life (PDQ-39) and Different Questionnaires at Month 6
Hide Description

Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for “yes” and 0 for “no.” The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Time Frame Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and Month 6 assessments.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: correlation coefficient
PDQ-39 with UPDRS-III Number Analyzed 53 participants
0.30902
PDQ-39 with UPDRS-IV Number Analyzed 53 participants
0.35220
PDQ-39 with NMSS Number Analyzed 52 participants
0.36814
PDQ-39 with BAI Number Analyzed 53 participants
0.60620
PDQ-39 with BDI-II Number Analyzed 53 participants
0.56325
PDQ-39 with AS Number Analyzed 53 participants
0.23657
PDQ-39 with PFS Number Analyzed 53 participants
0.58572
PDQ-39 with NBL A-S Number Analyzed 53 participants
0.54139
PDQ-39 with NBL C-D Number Analyzed 53 participants
0.54140
PDQ-39 with NBL C-R Number Analyzed 53 participants
0.38968
PDQ-39 with ZBI Number Analyzed 48 participants
-0.32445
PDQ-39 with GADS-Anxiety Number Analyzed 48 participants
0.56873
PDQ-39 with GADS-Depression Number Analyzed 15 participants
0.10855
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with UPDRS-III
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0239
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.31946
Confidence Interval (2-Sided) 95%
0.042257 to 0.534657
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with UPDRS-IV
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0093
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.36796
Confidence Interval (2-Sided) 95%
0.090528 to 0.568388
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NMSS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.38627
Confidence Interval (2-Sided) 95%
0.105875 to 0.582517
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with BAI
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.70289
Confidence Interval (2-Sided) 95%
0.401730 to 0.753097
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with BDI-II
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.63758
Confidence Interval (2-Sided) 95%
0.345567 to 0.723410
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with AS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0882
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.24114
Confidence Interval (2-Sided) 95%
-0.036024 to 0.476404
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with PFS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.67113
Confidence Interval (2-Sided) 95%
0.374757 to 0.739016
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NBL A-S
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.60612
Confidence Interval (2-Sided) 95%
0.317572 to 0.708072
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NBL C-D
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.60613
Confidence Interval (2-Sided) 95%
0.317580 to 0.708076
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with NBL C-R
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.41143
Confidence Interval (2-Sided) 95%
0.133445 to 0.597087
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with ZBI
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0239
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.33661
Confidence Interval (2-Sided) 95%
-0.557217 to -0.044411
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with Goldberg-Anxiety
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.64565
Confidence Interval (2-Sided) 95%
0.339454 to 0.734221
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection All Participants
Comments PDQ-39 with Goldberg-Depression
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7058
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.10898
Confidence Interval (2-Sided) 95%
-0.427482 to 0.588111
Estimation Comments [Not Specified]
50.Secondary Outcome
Title Correlation Between Caregivers’ Quality of Life (SQLC) and Different Questionnaires at Baseline
Hide Description

Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for “yes” and 0 for “no.” The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline assessments.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: correlation coefficient
SQLC with ZBI Number Analyzed 54 participants
-0.51735
SQLC with GADS-Anxiety Number Analyzed 28 participants
-0.16188
SQLC with GADS-Depression Number Analyzed 25 participants
-0.44739
SQLC with NBL A-S Number Analyzed 53 participants
0.06318
SQLC with NBL C-D Number Analyzed 53 participants
0.17492
SQLC with NBL C-R Number Analyzed 53 participants
0.28618
SQLC with Global PDQ-39 Number Analyzed 54 participants
-0.35125
SQLC with UPDRS-III Number Analyzed 54 participants
-0.13353
SQLC with UPDRS-IV Number Analyzed 54 participants
0.17659
SQLC with Global NMSS Number Analyzed 54 participants
0.01625
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with ZBI
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.57271
Confidence Interval (2-Sided) 95%
-0.689585 to -0.289724
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with Goldberg Anxiety
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4142
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.16332
Confidence Interval (2-Sided) 95%
-0.504489 to 0.224771
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with Goldberg Depression
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0239
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.48143
Confidence Interval (2-Sided) 95%
-0.715956 to -0.063481
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with NBL A-S
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6546
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.06326
Confidence Interval (2-Sided) 95%
-0.210715 to 0.327872
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with NBL C-D
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2114
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.17674
Confidence Interval (2-Sided) 95%
-0.100105 to 0.425116
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with NBL C-R
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0374
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.29440
Confidence Interval (2-Sided) 95%
0.017222 to 0.516523
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with Global PDQ-39
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0088
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.36687
Confidence Interval (2-Sided) 95%
-0.565795 to -0.092154
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with UPDRS-III
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3374
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.13433
Confidence Interval (2-Sided) 95%
-0.387439 to 0.139207
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with UPDRS-IV
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2025
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.17846
Confidence Interval (2-Sided) 95%
-0.095693 to 0.424291
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with Global NMSS
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9076
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.01625
Confidence Interval (2-Sided) 95%
-0.252613 to 0.282777
Estimation Comments [Not Specified]
51.Secondary Outcome
Title Correlation Between Caregivers’ Quality of Life (SQLC) and Different Questionnaires at Month 6
Hide Description

Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).

The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for “yes” and 0 for “no.” The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability.

Time Frame Month 6 (±15 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed Month 6 assessments.
Arm/Group Title All Participants
Hide Arm/Group Description:
LCIG prescribed in the usual manner, in accordance with the terms of the local marketing authorization, for participants with advanced Parkinson’s disease with motor fluctuation not well responding to conventional therapies.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: correlation coefficient
SQLC with ZBI Number Analyzed 48 participants
-0.63324
SQLC with GADS Anxiety Number Analyzed 15 participants
0.17735
SQLC with GADS Depression Number Analyzed 13 participants
-0.06976
SQLC with NBL A-S Number Analyzed 48 participants
-0.11015
SQLC with NBL C-D Number Analyzed 48 participants
0.00326
SQLC with NBL C-R Number Analyzed 48 participants
-0.10256
SQLC with Global PDQ-39 Number Analyzed 48 participants
-0.32445
SQLC with UPDRS-III Number Analyzed 48 participants
-0.23226
SQLC with UPDRS-IV Number Analyzed 48 participants
-0.12942
SQLC with Global NMSS Number Analyzed 47 participants
0.11635
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with ZBI
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.74680
Confidence Interval (2-Sided) 95%
-0.777482 to -0.425693
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with Goldberg Anxiety
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5347
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value 0.17924
Confidence Interval (2-Sided) 95%
-0.368382 to 0.632178
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with Goldberg Depression
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8251
Comments [Not Specified]
Method Fisher's z Transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.06987
Confidence Interval (2-Sided) 95%
-0.597767 to 0.500464
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with NBL A-S
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4581
Comments [Not Specified]
Method Fisher's z transformation
Comments [Not Specified]
Method of Estimation Estimation Parameter Fisher's z
Estimated Value -0.11060
Confidence Interval (2-Sided) 95%
-0.382323 to 0.179601
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection All Participants
Comments SQLC with NBL C-D
Type of Statistical Test Other