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Trial record 66 of 533 for:    Taste Disorders

A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease

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: NCT01736176
Recruitment Status : Completed
First Posted : November 29, 2012
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Parkinson's Disease
Interventions Drug: Levodopa-Carbidopa Intestinal Gel
Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)
Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets
Enrollment 39
Recruitment Details This study was conducted at 12 sites in the United States that specialized in movement disorders. Participants were levodopa-responsive with advanced Parkinson's disease (PD) and persistent motor fluctuations despite attempts to optimize treatment with oral levodopa-carbidopa and other available anti-PD medications.
Pre-assignment Details During screening participants converted their current daytime levodopa-carbidopa doses to oral levodopa-carbidopa 100/25 mg immediate release (LC-IR); other anti-PD medications could be continued, reduced or discontinued at the investigator's discretion. LC-IR and all other anti-PD treatments were discontinued at LCIG initiation.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel (LCIG)
Hide Arm/Group Description Participants had a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.
Period Title: Overall Study
Started 39 [1]
Received LCIG 38
Completed 28
Not Completed 11
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             4
Lack of Efficacy             3
Unable to Complete PEG Placement             1
[1]
Enrolled participants who underwent the PEG-J placement procedure
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
64.3  (10.23)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
< 65 years
17
  43.6%
≥ 65 years
22
  56.4%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
16
  41.0%
Male
23
  59.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
White
36
  92.3%
Black or African American
1
   2.6%
Asian
2
   5.1%
American Indian or Alaska Native
0
   0.0%
Native Hawaiian or other Pacific Islander
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Hispanic or Latino
2
   5.1%
Not Hispanic or Latino
37
  94.9%
Duration of PD  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
11.5  (5.34)
PD Symptoms Present  
Measure Type: Count of Participants
Unit of measure:  Participants
Bradykinesia Number Analyzed 39 participants
37
  94.9%
Muscular rigidity Number Analyzed 39 participants
33
  84.6%
Resting tremor Number Analyzed 39 participants
25
  64.1%
Postural instability Number Analyzed 39 participants
22
  56.4%
Non-Motor Symptoms Scale (NMSS) Total Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 38 participants
48.3  (35.63)
[1]
Measure Description: The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity is rated on a scale from 0 (none) to 3 (severe). Frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The NMSS total score ranges from 0 to 360 with a lower score more desirable than a higher score. Baseline was the last measurement before the first dose of oral study drug.
[2]
Measure Analysis Population Description: Data are reported for the efficacy dataset which includes all participants who received at least 1 infusion of LCIG study drug and had a baseline and LCIG Treatment Period observation for at least one efficacy or health outcome measure.
1.Primary Outcome
Title Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.

Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy dataset included all participants who received at least 1 infusion of LCIG study drug and had a baseline and LCIG Treatment Period observation for at least one efficacy or health outcome measure.
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 35
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-17.6  (3.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel
Comments The primary null hypothesis was no change in least-square (LS) mean, calculated using a mixed-effect repeated measures model (MMRM), for NMSS total score from baseline to Week 12. The statistical test was two-sided and the null hypothesis was rejected at the significance level of α = 0.050.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Mixed-effect Repeated Measures (MMRM)
Comments MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.
2.Secondary Outcome
Title Number of Participants Who Used Healthcare Resources During the First 4 Weeks
Hide Description

Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The Week 4 version of the questionnaire addressed the following questions during the first four weeks after the PEG-J procedure:

  1. Has the subject had a visit to an emergency room?
  2. Has the subject had a visit to an urgent care?
  3. Has the subject had an outpatient visit to a neurologist?
  4. Has the subject had an outpatient visit to a gastroenterologist, surgeon, or interventional radiologist?
  5. Has the subject had an outpatient visit to a primary care physician?
  6. Has the subject called the nursing support line?
  7. Has the subject called a physician?
Time Frame Weeks 1-4
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety dataset included all participants who underwent the PEG-J placement procedure
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
Q1. Emergency Room Visit
3
   7.9%
Q2. Urgent Care Visit
0
   0.0%
Q3. Neurologist Visit
6
  15.8%
Q4. Gastroenterologist, Surgeon, Radiologist Visit
11
  28.9%
Q5. Primary Care Physician Visit
8
  21.1%
Q6. Called Nursing Support Line
9
  23.7%
Q7. Called Physician
13
  34.2%
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Adverse events (AEs) related to treatment are those the investigator determined as having a reasonable possibility being related to study drug based on evidence to suggest a causal relationship between the study drug and the adverse event.

A severe AE was defined as an adverse event that caused considerable interference with the participant's usual activities and might be incapacitating or life-threatening.

Serious AEs were defined as those that were life-threatening or resulted in death, hospitalization or prolongation of hospitalization, a congenital anomaly, persistent or significant disability/incapacity, or important medical events requiring medical or surgical intervention to prevent a serious outcome.

Time Frame Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety dataset
Arm/Group Title Week 1-4 Overall
Hide Arm/Group Description:
Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure through week 4.
Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure and no more than 30 days after the end of the LCIG Treatment Period.
Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
28
  71.8%
37
  94.9%
AE related to LCIG
26
  66.7%
35
  89.7%
AE related to oral LC
4
  10.3%
11
  28.2%
Severe adverse event
1
   2.6%
5
  12.8%
Serious adverse event
3
   7.7%
8
  20.5%
AE leading to premature discontinuation
1
   2.6%
5
  12.8%
Gastrointestinal (GI) adverse event
22
  56.4%
28
  71.8%
Adverse event other than GI
21
  53.8%
37
  94.9%
Fatal adverse event
0
   0.0%
1
   2.6%
4.Secondary Outcome
Title Number of Participants Who Used Healthcare Resources Through Week 60
Hide Description

Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The standard version of the questionnaire addressed the following questions over the last 3 months:

  1. Has the subject had a visit to an emergency room?
  2. Has the subject had an outpatient visit to any of the following healthcare providers?
  3. Has the subject been visited in his or her place of residence by a health care professional?
  4. Has the subject received assistance from either of the following for their Parkinson's disease in their home?
  5. Has the subject needed to contact either of the following for immediate assistance related to their Parkinson's disease?
  6. Have family members or friends had to miss any paid work due to the subject's Parkinson's disease?
  7. Has the subject fallen during the past month?
Time Frame Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety dataset with available data
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Q1. Emergency Room Visit
1
   2.9%
Q2. Visit to Primary Care Physician
18
  52.9%
Q2. Visit to Gastroenterologist
3
   8.8%
Q2. Visit to Interventional Radiologist
1
   2.9%
Q2. Visit to Surgeon
1
   2.9%
Q2. Visit to Cardiologist
1
   2.9%
Q2. Visit to Endocrinologist
0
   0.0%
Q2. Visit to Immunologist
0
   0.0%
Q2. Visit to Internist
1
   2.9%
Q2. Visit to Psychiatrist
0
   0.0%
Q2. Visit to Urologist
2
   5.9%
Q2. Visit to Psychologist
1
   2.9%
Q2. Visit to Social Worker
2
   5.9%
Q2. Visit to Other Healthcare Provider
10
  29.4%
Q3. Visited by Physician
0
   0.0%
Q3. Visited by Nurse or Nurse Practitioner
1
   2.9%
Q3. Visited by Physical or Occupational Therapist
0
   0.0%
Q4. Received Unpaid Care From Family/Friend
10
  29.4%
Q4. Received Care From Paid Caregiver
2
   5.9%
Q5. Called 911
0
   0.0%
Q5. Called Family/Friend
1
   2.9%
Q6. Family/Friends Missed Work
2
   5.9%
Q7. Fall During Past Month
10
  29.4%
5.Secondary Outcome
Title Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.

Time Frame Baseline and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at baseline and week 60
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-11.8  (3.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levodopa-Carbidopa Intestinal Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed-effect Repeated Measures (MMRM)
Comments MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.
6.Secondary Outcome
Title Change From Baseline in NMSS Cardiovascular Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS cardiovascular including falls 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time points
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-0.2  (0.37)
Week 60 Number Analyzed 28 participants
0.5  (0.41)
7.Secondary Outcome
Title Change From Baseline in NMSS Sleep/Fatigue Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-6.0  (1.17)
Week 60 Number Analyzed 28 participants
-5.4  (1.29)
8.Secondary Outcome
Title Change From Baseline in NMSS Mood/Cognition Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
0.0  (1.12)
Week 60 Number Analyzed 28 participants
0.5  (1.24)
9.Secondary Outcome
Title Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-0.5  (0.38)
Week 60 Number Analyzed 28 participants
0.4  (0.43)
10.Secondary Outcome
Title Change From Baseline in NMSS Attention/Memory Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-2.1  (0.80)
Week 60 Number Analyzed 28 participants
-2.2  (0.87)
11.Secondary Outcome
Title Change From Baseline in NMSS Gastrointestinal Tract Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-2.0  (0.60)
Week 60 Number Analyzed 28 participants
-1.9  (0.67)
12.Secondary Outcome
Title Change From Baseline in NMSS Urinary Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-2.2  (1.07)
Week 60 Number Analyzed 28 participants
0.1  (1.19)
13.Secondary Outcome
Title Change From Baseline in NMSS Sexual Function Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-1.8  (0.42)
Week 60 Number Analyzed 28 participants
-1.1  (0.47)
14.Secondary Outcome
Title Change From Baseline in NMSS Miscellaneous Domain Score
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, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). 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).

Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS 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 and Week 12 and Week 60
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Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-3.4  (1.00)
Week 60 Number Analyzed 28 participants
-3.4  (1.11)
15.Secondary Outcome
Title Change From Baseline in Mean Daily Normalized "Off" Time Based on Parkinson's Disease Diary
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The Parkinson's Disease Diary was completed by the participant for 3 consecutive days prior to each visit for the full 24 hours of each day. Participants recorded whether they had been "On," "Off," or "Asleep" and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from time asleep.

"Off" time was defined as time when medication has worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness.

Parkinson's Disease Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: hours
Week 12 Number Analyzed 32 participants
-4.1  (0.39)
Week 60 Number Analyzed 21 participants
-4.9  (0.48)
16.Secondary Outcome
Title Change From Baseline in Mean Daily Normalized "On" Time Without Troublesome Dyskinesia Based on PD Diary
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The PD Diary was completed by the participant for 3 consecutive days prior to each visit. Participants recorded whether they had been "On," "Off," or "Asleep" and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from sleep.

"On" was defined as time when medication was providing benefit with regard to mobility, slowness, and stiffness. "On" time without troublesome dyskinesia is a composite of "On" time without dyskinesia (involuntary twisting, turning movements which are an effect of medication) plus "On" time with non-troublesome dyskinesia (dyskinesia that does not interfere with function or cause meaningful discomfort).

PD Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: hours
Week 12 Number Analyzed 32 participants
3.7  (0.48)
Week 60 Number Analyzed 21 participants
4.3  (0.58)
17.Secondary Outcome
Title Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
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The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.

The UPDRS was made up of the following sections:

  • Part I – Mentation, Behavior, and Mood
  • Part II – Activities of Daily Living
  • Part III – Motor Examination
  • Part IV – Complications of Therapy (including dyskinesias)
  • Part V – Modified Hoehn and Yahr Staging

The Total UPDRS score includes 31 items contributing to three subscales: (I) Mentation, Behavior, and Mood; (II) Activities of Daily Living; and (III) Motor Examination. Each question is answered on a scale from 0 (None) to 4 (Severe); Some questions require multiple grades assigned to each extremity. The UPDRS Total score was computed as the sum of these 3 UPDRS subscales and ranged from 0 to 176, with 176 representing the worst (total) disability, and 0 no disability.

Time Frame Baseline and Week 12 and Week 60
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Efficacy dataset with available data at baseline (37) and each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 37
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-11.4  (1.67)
Week 60 Number Analyzed 28 participants
-7.7  (2.26)
18.Secondary Outcome
Title Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score
Hide Description

The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.

The UPDRS was made up of the following sections:

  • Part I – Mentation, Behavior, and Mood
  • Part II – Activities of Daily Living
  • Part III – Motor Examination
  • Part IV – Complications of Therapy (including dyskinesias)
  • Part V – Modified Hoehn and Yahr Staging

The mentation, behavior, and mood score includes 4 items addressing intellectual impairment, thought disorder, motivation/initiative, and depression. Each question is answered on a scale from 0 (None) to 4 (Severe). The UPDRS Part I: mentation, behavior, and mood score was computed as the sum of these items and ranged from 0 (not affected) to 16 (most severely affected).

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at baseline (37) and each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 37
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-0.3  (0.31)
Week 60 Number Analyzed 28 participants
-0.1  (0.26)
19.Secondary Outcome
Title Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score
Hide Description

The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.

The UPDRS was made up of the following sections:

  • Part I – Mentation, Behavior, and Mood
  • Part II – Activities of Daily Living
  • Part III – Motor Examination
  • Part IV – Complications of Therapy (including dyskinesias)
  • Part V – Modified Hoehn and Yahr Staging

The activities of daily living score includes 13 items addressing speech, salivation, swallowing, handwriting, cutting food, dressing, hygiene, turning in bed, falling, freezing, walking, tremor, and sensory complaints. Each question is answered on a scale from 0 (Normal) to 4 (Severe). The UPDRS Part II: activities of daily living score was computed as the sum of these items and ranged from 0 (not affected) to 52 (most severely affected).

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at baseline (37) and at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 37
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-5.5  (0.89)
Week 60 Number Analyzed 28 participants
-4.7  (0.92)
20.Secondary Outcome
Title Change From Baseline in UPDRS Part III: Motor Examination Score
Hide Description

The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.

The UPDRS was made up of the following sections:

  • Part I – Mentation, Behavior, and Mood
  • Part II – Activities of Daily Living
  • Part III – Motor Examination
  • Part IV – Complications of Therapy (including dyskinesias)
  • Part V – Modified Hoehn and Yahr Staging

The motor examination score includes 17 items addressing speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. Each question is answered on a scale from 0 (Normal) to 4 (Severe), some items include multiple grades for each extremity. The UPDRS Part III: motor examination score was computed as the sum of these items and ranged from 0 (not affected) to 108 (most severely affected).

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at baseline (37) and at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 37
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-5.6  (1.19)
Week 60 Number Analyzed 28 participants
-3.6  (1.49)
21.Secondary Outcome
Title Change From Baseline in UPDRS Part IV: Complications of Therapy Score
Hide Description

The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.

The UPDRS was made up of the following sections:

  • Part I – Mentation, Behavior, and Mood
  • Part II – Activities of Daily Living
  • Part III – Motor Examination
  • Part IV – Complications of Therapy (including dyskinesias)
  • Part V – Modified Hoehn and Yahr Staging

The complications of therapy section includes 11 items addressing dyskinesia duration, disability, and pain, early morning dystonia, “offs”-predictable, “offs”-unpredictable, “offs”-sudden, “offs”-duration, anorexia-nausea-vomiting, sleep disturbance, and symptomatic orthostasis. Four questions are answered on a scale from 0 (Normal) to 4 (Severe) and seven on a binary scale where 0=No and 1=Yes. The UPDRS Part IV: complications of therapy score was computed as the sum of these items and ranged from 0 (not affected) to 23 (most severely affected).

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-3.5  (0.44)
Week 60 Number Analyzed 28 participants
-2.9  (0.57)
22.Secondary Outcome
Title Change From Baseline in UPDRS Dyskinesia Items Score
Hide Description

The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.

The UPDRS was made up of the following sections:

  • Part I – Mentation, Behavior, and Mood
  • Part II – Activities of Daily Living
  • Part III – Motor Examination
  • Part IV – Complications of Therapy (including dyskinesias)
  • Part V – Modified Hoehn and Yahr Staging

The dyskinesia items score includes questions 32, 33 and 34 from the complications of therapy section of the UPDRS which address dyskinesia duration, disability, and pain. Each question was answered on a scale from 0 (Normal) to 4 (Severe); the UPDRS dyskinesia items score was computed as the sum of these items and ranged from 0 (not affected) to 12 (most severely affected).

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-1.1  (0.28)
Week 60 Number Analyzed 28 participants
-0.6  (0.36)
23.Secondary Outcome
Title Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score
Hide Description

The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.

The UPDRS was made up of the following sections:

  • Part I – Mentation, Behavior, and Mood
  • Part II – Activities of Daily Living
  • Part III – Motor Examination
  • Part IV – Complications of Therapy (including dyskinesias)
  • Part V – Modified Hoehn and Yahr Staging

The modified Hoehn and Yahr scale is as follows:

  • Stage 0: No signs of disease
  • Stage 1.0: Symptoms are very mild; unilateral involvement only
  • Stage 1.5: Unilateral and axial involvement
  • Stage 2: Bilateral involvement without impairment of balance
  • Stage 2.5: Mild bilateral disease with recovery on pull test
  • Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent
  • Stage 4: Severe disability; still able to walk or stand unassisted
  • Stage 5: Wheelchair bound or bedridden unless aided
Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 35 participants
-0.2  (0.10)
Week 60 Number Analyzed 28 participants
-0.2  (0.12)
24.Secondary Outcome
Title Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 – 100 scale where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-11.2  (2.75)
Week 60 Number Analyzed 28 participants
-10.2  (2.63)
25.Secondary Outcome
Title Change From Baseline in PDQ-39 Mobility Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-18.5  (4.39)
Week 60 Number Analyzed 28 participants
-19.4  (4.21)
26.Secondary Outcome
Title Change From Baseline in PDQ-39 Activities of Daily Living Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-12.1  (4.43)
Week 60 Number Analyzed 28 participants
-11.9  (4.23)
27.Secondary Outcome
Title Change From Baseline in PDQ-39 Emotional Well-Being Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-4.9  (3.14)
Week 60 Number Analyzed 26 participants
-6.6  (3.74)
28.Secondary Outcome
Title Change From Baseline in PDQ-39 Stigma Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-9.5  (2.38)
Week 60 Number Analyzed 28 participants
-5.4  (3.01)
29.Secondary Outcome
Title Change From Baseline in PDQ-39 Social Support Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
1.6  (2.62)
Week 60 Number Analyzed 28 participants
3.3  (2.95)
30.Secondary Outcome
Title Change From Baseline in PDQ-39 Cognition Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-8.4  (2.23)
Week 60 Number Analyzed 28 participants
-7.3  (2.00)
31.Secondary Outcome
Title Change From Baseline in PDQ-39 Communication Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 34 participants
-13.0  (3.24)
Week 60 Number Analyzed 27 participants
-10.8  (2.59)
32.Secondary Outcome
Title Change From Baseline in PDQ-39 Bodily Discomfort Domain Score
Hide Description

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).

Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness.

Time Frame Baseline and Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data at each time point
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 12 Number Analyzed 33 participants
-9.6  (4.40)
Week 60 Number Analyzed 28 participants
-3.8  (3.65)
33.Secondary Outcome
Title Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved
Hide Description

The PGIC is a 7-point response scale. Participants were asked to rate their change in status using the following 7-point scale:

1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.

The responses of "Very much improved," "Much improved" and "Minimally improved" on the PGIC were used to define responders.

Time Frame Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 78.9
Week 60 71.1
34.Secondary Outcome
Title Treatment Satisfaction Questionnaire Scores
Hide Description The Treatment Satisfaction Questionnaire (TSQ) is a single item instrument developed by the Sponsor on which the participant indicated their level of satisfaction or dissatisfaction with their PD treatment. The responses are recorded on a Likert-type scale (Very Satisfied, Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied).
Time Frame Week 12 and Week 60
Hide Outcome Measure Data
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Efficacy dataset
Arm/Group Title Week 12 Week 60
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 38 38
Measure Type: Count of Participants
Unit of Measure: Participants
Very satisfied
15
  39.5%
14
  36.8%
Satisfied
14
  36.8%
9
  23.7%
Somewhat satisfied
4
  10.5%
3
   7.9%
Somewhat dissatisfied
1
   2.6%
1
   2.6%
Dissatisfied
1
   2.6%
0
   0.0%
Very dissatisfied
0
   0.0%
1
   2.6%
Missing
3
   7.9%
10
  26.3%
35.Secondary Outcome
Title Change From Baseline in Health-related Productivity
Hide Description

The Health-Related Productivity Questionnaire (HRPQ) is a generic measure of the impact of disease on the ability of the participant to be productive at paid employment or at performance of household chores. Questions inquire about the amount of time they were scheduled/planned to work, the number of the scheduled/planned hours they were able to work and their ability to be productive for the hours of work they did perform.

Absenteeism: Number of hours not worked due to PD or it's treatments;

Presenteeism: Number of hours of lost productivity while at work due to PD or it's treatments;

Total hours lost: Number of hours lost due to absenteeism and presenteeism

Time Frame Baseline, Week 12 and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data. Workplace hours lost is calculated for participants who were employed.
Arm/Group Title Week 12 Week 60
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: hours
Workplace Work Lost - Absenteeism Number Analyzed 7 participants 6 participants
-2.1  (4.63) -5.2  (6.27)
Household Work Lost - Absenteeism Number Analyzed 23 participants 21 participants
-3.5  (11.19) -1.9  (8.38)
Workplace Work Lost - Presenteeism Number Analyzed 7 participants 6 participants
-0.8  (13.04) -0.3  (3.87)
Household Work Lost - Presenteeism Number Analyzed 23 participants 21 participants
-1.8  (6.42) -1.9  (5.42)
Total Workplace Work Lost Number Analyzed 7 participants 6 participants
-3.0  (8.87) -5.5  (4.50)
Total Household Work Lost Number Analyzed 23 participants 21 participants
-5.3  (15.69) -3.8  (11.26)
36.Secondary Outcome
Title Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12
Hide Description CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The between errors score is the number of times the participant revisited a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: errors
-0.6  (7.73)
37.Secondary Outcome
Title Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12
Hide Description CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.8  (2.31)
38.Secondary Outcome
Title Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60
Hide Description

Letter fluency was assessed using a paper and pen test, in which participants were asked to generate as many words as possible in 60 seconds, starting with the letters F, A, or S.

The COWAT All Letters score is the number of words recalled in all post-baseline assessments, regardless of letter used.

The COWAT Baseline Letter score is the number of words recalled in post-baseline assessments that used the same letter as at Baseline.

Time Frame Baseline and Week 60
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy dataset with available data
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description:
Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: words
All Letters Score Number Analyzed 20 participants
-0.5  (4.80)
Baseline Letter Score Number Analyzed 12 participants
-1.8  (4.03)
Time Frame Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levodopa-Carbidopa Intestinal Gel
Hide Arm/Group Description Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
All-Cause Mortality
Levodopa-Carbidopa Intestinal Gel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levodopa-Carbidopa Intestinal Gel
Affected / at Risk (%)
Total   8/39 (20.51%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  1/39 (2.56%) 
CARDIAC FAILURE CONGESTIVE  1  1/39 (2.56%) 
Gastrointestinal disorders   
INTERNAL HERNIA  1  1/39 (2.56%) 
Infections and infestations   
PERITONITIS  1  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders   
OSTEOARTHRITIS  1  1/39 (2.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BASAL CELL CARCINOMA  1  1/39 (2.56%) 
Nervous system disorders   
RADICULOPATHY  1  1/39 (2.56%) 
SEDATION  1  1/39 (2.56%) 
Psychiatric disorders   
ANXIETY  1  1/39 (2.56%) 
MAJOR DEPRESSION  1  1/39 (2.56%) 
SUICIDAL IDEATION  1  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
ACUTE RESPIRATORY FAILURE  1  1/39 (2.56%) 
PNEUMONIA ASPIRATION  1  1/39 (2.56%) 
RESPIRATORY DISTRESS  1  1/39 (2.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levodopa-Carbidopa Intestinal Gel
Affected / at Risk (%)
Total   36/39 (92.31%) 
Blood and lymphatic system disorders   
ANAEMIA  1  1/39 (2.56%) 
Cardiac disorders   
ATRIAL FIBRILLATION  1  1/39 (2.56%) 
CARDIAC FAILURE CONGESTIVE  1  1/39 (2.56%) 
TACHYCARDIA  1  1/39 (2.56%) 
Ear and labyrinth disorders   
EAR PAIN  1  1/39 (2.56%) 
Eye disorders   
AMAUROSIS FUGAX  1  1/39 (2.56%) 
CATARACT  1  1/39 (2.56%) 
DRY EYE  1  1/39 (2.56%) 
MACULAR DEGENERATION  1  1/39 (2.56%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  1/39 (2.56%) 
ABDOMINAL PAIN  1  3/39 (7.69%) 
ABDOMINAL PAIN LOWER  1  1/39 (2.56%) 
ABDOMINAL PAIN UPPER  1  1/39 (2.56%) 
ABDOMINAL TENDERNESS  1  1/39 (2.56%) 
BARRETT'S OESOPHAGUS  1  1/39 (2.56%) 
CONSTIPATION  1  3/39 (7.69%) 
DENTAL CARIES  1  1/39 (2.56%) 
DIARRHOEA  1  2/39 (5.13%) 
DIVERTICULUM  1  1/39 (2.56%) 
DRY MOUTH  1  2/39 (5.13%) 
DYSPHAGIA  1  1/39 (2.56%) 
FAECES SOFT  1  1/39 (2.56%) 
FLATULENCE  1  4/39 (10.26%) 
GASTRIC POLYPS  1  1/39 (2.56%) 
GASTRITIS  1  1/39 (2.56%) 
GASTROINTESTINAL DISORDER  1  1/39 (2.56%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  2/39 (5.13%) 
HIATUS HERNIA  1  1/39 (2.56%) 
ILEUS  1  1/39 (2.56%) 
INGUINAL HERNIA  1  2/39 (5.13%) 
NAUSEA  1  4/39 (10.26%) 
PANCREATIC MASS  1  1/39 (2.56%) 
SMALL INTESTINAL OBSTRUCTION  1  1/39 (2.56%) 
TOOTHACHE  1  1/39 (2.56%) 
VOMITING  1  1/39 (2.56%) 
General disorders   
ADMINISTRATION SITE ODOUR  1  1/39 (2.56%) 
APPLICATION SITE IRRITATION  1  1/39 (2.56%) 
CATHETER SITE DERMATITIS  1  1/39 (2.56%) 
CATHETER SITE ERYTHEMA  1  1/39 (2.56%) 
CATHETER SITE HAEMATOMA  1  1/39 (2.56%) 
CATHETER SITE PAIN  1  1/39 (2.56%) 
CYST  1  1/39 (2.56%) 
DEVICE DISLOCATION  1  2/39 (5.13%) 
DRUG EFFECT DECREASED  1  1/39 (2.56%) 
FATIGUE  1  1/39 (2.56%) 
FEELING COLD  1  1/39 (2.56%) 
INFLAMMATION  1  1/39 (2.56%) 
NON-CARDIAC CHEST PAIN  1  1/39 (2.56%) 
OEDEMA PERIPHERAL  1  1/39 (2.56%) 
PAIN  1  2/39 (5.13%) 
PYREXIA  1  1/39 (2.56%) 
Hepatobiliary disorders   
BILE DUCT STONE  1  1/39 (2.56%) 
Infections and infestations   
BRONCHITIS  1  1/39 (2.56%) 
CYSTITIS  1  1/39 (2.56%) 
LOCALISED INFECTION  1  2/39 (5.13%) 
PNEUMONIA  1  2/39 (5.13%) 
PYODERMA  1  1/39 (2.56%) 
STOMA SITE ABSCESS  1  2/39 (5.13%) 
STOMA SITE INFECTION  1  11/39 (28.21%) 
TOOTH INFECTION  1  1/39 (2.56%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/39 (2.56%) 
URINARY TRACT INFECTION  1  6/39 (15.38%) 
Injury, poisoning and procedural complications   
ACCIDENTAL OVERDOSE  1  1/39 (2.56%) 
AGITATION POSTOPERATIVE  1  1/39 (2.56%) 
ARTHROPOD BITE  1  1/39 (2.56%) 
FALL  1  7/39 (17.95%) 
LACERATION  1  3/39 (7.69%) 
OESOPHAGEAL INJURY  1  1/39 (2.56%) 
POST PROCEDURAL HAEMORRHAGE  1  1/39 (2.56%) 
PROCEDURAL COMPLICATION  1  1/39 (2.56%) 
PROCEDURAL PAIN  1  13/39 (33.33%) 
ROAD TRAFFIC ACCIDENT  1  1/39 (2.56%) 
SKIN ABRASION  1  2/39 (5.13%) 
STERNAL FRACTURE  1  1/39 (2.56%) 
STOMA SITE DISCHARGE  1  3/39 (7.69%) 
STOMA SITE ERYTHEMA  1  8/39 (20.51%) 
STOMA SITE HAEMORRHAGE  1  3/39 (7.69%) 
STOMA SITE INFLAMMATION  1  1/39 (2.56%) 
STOMA SITE IRRITATION  1  4/39 (10.26%) 
STOMA SITE PAIN  1  9/39 (23.08%) 
THORACIC VERTEBRAL FRACTURE  1  1/39 (2.56%) 
ULNAR NERVE INJURY  1  1/39 (2.56%) 
Investigations   
BLOOD CHOLESTEROL INCREASED  1  1/39 (2.56%) 
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  1/39 (2.56%) 
BLOOD LACTATE DEHYDROGENASE INCREASED  1  1/39 (2.56%) 
VIBRATION TEST ABNORMAL  1  1/39 (2.56%) 
VITAMIN B12 DECREASED  1  2/39 (5.13%) 
VITAMIN B6 DECREASED  1  2/39 (5.13%) 
VITAMIN B6 INCREASED  1  1/39 (2.56%) 
WEIGHT DECREASED  1  7/39 (17.95%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  1/39 (2.56%) 
DEHYDRATION  1  2/39 (5.13%) 
DYSLIPIDAEMIA  1  1/39 (2.56%) 
VITAMIN B12 DEFICIENCY  1  3/39 (7.69%) 
VITAMIN B6 DEFICIENCY  1  4/39 (10.26%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN  1  2/39 (5.13%) 
BURSITIS  1  1/39 (2.56%) 
FLANK PAIN  1  1/39 (2.56%) 
GROIN PAIN  1  1/39 (2.56%) 
JOINT EFFUSION  1  1/39 (2.56%) 
JOINT SWELLING  1  1/39 (2.56%) 
LIMB DISCOMFORT  1  1/39 (2.56%) 
MYALGIA  1  2/39 (5.13%) 
NECK PAIN  1  1/39 (2.56%) 
OSTEOARTHRITIS  1  1/39 (2.56%) 
PAIN IN EXTREMITY  1  2/39 (5.13%) 
ROTATOR CUFF SYNDROME  1  1/39 (2.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BASAL CELL CARCINOMA  1  2/39 (5.13%) 
HAEMANGIOMA OF SKIN  1  1/39 (2.56%) 
LIPOMA  1  1/39 (2.56%) 
MELANOCYTIC NAEVUS  1  1/39 (2.56%) 
SEBORRHOEIC KERATOSIS  1  1/39 (2.56%) 
SQUAMOUS CELL CARCINOMA OF SKIN  1  2/39 (5.13%) 
Nervous system disorders   
AKINESIA  1  1/39 (2.56%) 
AREFLEXIA  1  1/39 (2.56%) 
BALANCE DISORDER  1  1/39 (2.56%) 
CARPAL TUNNEL SYNDROME  1  1/39 (2.56%) 
COGNITIVE DISORDER  1  3/39 (7.69%) 
DEMENTIA  1  1/39 (2.56%) 
DIZZINESS  1  1/39 (2.56%) 
DROOLING  1  1/39 (2.56%) 
DYSGEUSIA  1  1/39 (2.56%) 
DYSKINESIA  1  3/39 (7.69%) 
DYSTONIA  1  1/39 (2.56%) 
ENCEPHALOPATHY  1  1/39 (2.56%) 
HYPOAESTHESIA  1  2/39 (5.13%) 
LOSS OF PROPRIOCEPTION  1  1/39 (2.56%) 
LUMBAR RADICULOPATHY  1  1/39 (2.56%) 
NEUROPATHY PERIPHERAL  1  1/39 (2.56%) 
PARAESTHESIA  1  1/39 (2.56%) 
PARKINSON'S DISEASE  1  3/39 (7.69%) 
PERIPHERAL SENSORY NEUROPATHY  1  2/39 (5.13%) 
PRESYNCOPE  1  1/39 (2.56%) 
RESTLESS LEGS SYNDROME  1  1/39 (2.56%) 
SOMNOLENCE  1  1/39 (2.56%) 
Psychiatric disorders   
ABNORMAL BEHAVIOUR  1  1/39 (2.56%) 
ANXIETY  1  7/39 (17.95%) 
APATHY  1  1/39 (2.56%) 
DELUSION  1  1/39 (2.56%) 
DEPRESSED MOOD  1  1/39 (2.56%) 
DEPRESSION  1  3/39 (7.69%) 
HALLUCINATION  1  3/39 (7.69%) 
HYPOMANIA  1  1/39 (2.56%) 
INSOMNIA  1  3/39 (7.69%) 
SLEEP DISORDER  1  1/39 (2.56%) 
Renal and urinary disorders   
BLADDER OUTLET OBSTRUCTION  1  1/39 (2.56%) 
BLADDER SPASM  1  1/39 (2.56%) 
DYSURIA  1  1/39 (2.56%) 
MICTURITION URGENCY  1  1/39 (2.56%) 
NOCTURIA  1  1/39 (2.56%) 
POLLAKIURIA  1  1/39 (2.56%) 
RENAL CYST  1  1/39 (2.56%) 
RENAL FAILURE  1  1/39 (2.56%) 
URETHRAL HAEMORRHAGE  1  1/39 (2.56%) 
URINARY INCONTINENCE  1  1/39 (2.56%) 
URINARY RETENTION  1  1/39 (2.56%) 
Reproductive system and breast disorders   
PROSTATOMEGALY  1  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  1/39 (2.56%) 
DYSPNOEA  1  1/39 (2.56%) 
LUNG INFILTRATION  1  1/39 (2.56%) 
NASAL CONGESTION  1  1/39 (2.56%) 
OROPHARYNGEAL PAIN  1  1/39 (2.56%) 
PLEURAL EFFUSION  1  1/39 (2.56%) 
PULMONARY MASS  1  1/39 (2.56%) 
YAWNING  1  1/39 (2.56%) 
Skin and subcutaneous tissue disorders   
BLISTER  1  1/39 (2.56%) 
COLD SWEAT  1  1/39 (2.56%) 
DERMATITIS CONTACT  1  1/39 (2.56%) 
ECCHYMOSIS  1  1/39 (2.56%) 
EXCESSIVE GRANULATION TISSUE  1  4/39 (10.26%) 
HYPERHIDROSIS  1  2/39 (5.13%) 
HYPERKERATOSIS  1  1/39 (2.56%) 
LENTIGO  1  1/39 (2.56%) 
NIGHT SWEATS  1  1/39 (2.56%) 
RASH  1  1/39 (2.56%) 
RASH MACULAR  1  1/39 (2.56%) 
SKIN LESION  1  2/39 (5.13%) 
Vascular disorders   
ORTHOSTATIC HYPOTENSION  1  5/39 (12.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01736176     History of Changes
Other Study ID Numbers: M12-920
First Submitted: November 27, 2012
First Posted: November 29, 2012
Results First Submitted: December 16, 2016
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017