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Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy (BRIGHT)

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: NCT01782222
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : January 19, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Parkinson's Disease
Interventions Drug: Rotigotine
Other: Placebo
Enrollment 122
Recruitment Details This study was planned to be conducted globally with 480 subjects (160 subjects per treatment group for the Full Analysis Set). Approx. 600 subjects were planned for enrollment in order to obtain 504 subjects for randomization. Subjects were randomized in a 1:1:1 ratio to either Rotigotine low dose, Rotigotine high dose or Placebo.
Pre-assignment Details

The Participant Flow refers to the Randomized Set (RS). The RS included all subjects who were randomized.

The outcome of the Interim Analysis was to stop the study, i.e. no more subjects were enrolled into the study and all included subjects completed the study as planned.

Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Period Title: Overall Study
Started 40 41 41
Completed 32 30 37
Not Completed 8 11 4
Reason Not Completed
Adverse Event             4             5             3
Lack of Efficacy             2             1             0
Protocol Violation             1             0             0
Withdrawal by Subject             1             4             1
Moved to other state             0             1             0
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose Total
Hide Arm/Group Description

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Total of all reporting groups
Overall Number of Baseline Participants 40 41 41 122
Hide Baseline Analysis Population Description
The Baseline Analysis Population refers to the Safety Set (SS). The SS included all randomized subjects who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 41 participants 41 participants 122 participants
69.0  (11.7) 68.1  (10.5) 70.2  (8.0) 69.1  (10.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 41 participants 122 participants
>18 - < 65 years 14 17 12 43
≥ 65 years 26 24 29 79
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 41 participants 122 participants
Female
18
  45.0%
14
  34.1%
14
  34.1%
46
  37.7%
Male
22
  55.0%
27
  65.9%
27
  65.9%
76
  62.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 41 participants 41 participants 122 participants
Black 1 2 1 4
White 38 39 40 117
Other/mixed 1 0 0 1
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 40 participants 41 participants 41 participants 122 participants
79.59  (14.73) 77.34  (17.93) 78.96  (15.96) 78.62  (16.17)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 40 participants 41 participants 41 participants 122 participants
167.16  (10.34) 169.25  (10.76) 170.88  (10.94) 169.10  (10.70)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 40 participants 41 participants 41 participants 122 participants
28.53  (4.79) 26.86  (4.89) 26.90  (3.86) 27.42  (4.57)
1.Primary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient
Hide Description

The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.

The questions comprising the AS were answered by the subject. The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome).

Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 40 36 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-4.4  (4.9) -4.6  (6.7) -4.9  (5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.977
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-2.42 to 2.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.859
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-2.61 to 2.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.21
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Total Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living) + III (Motor Symptoms)
Hide Description Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject’s activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.
Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 40 36 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-4.8  (10.4) -12.4  (14.0) -10.7  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -7.29
Confidence Interval (2-Sided) 95%
-12.30 to -2.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -6.06
Confidence Interval (2-Sided) 95%
-10.90 to -1.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.45
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Caregiver (Where Available)
Hide Description

The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson’s disease because the Apathy Evaluation Scale was considered too demanding.

The questions comprising the AS were answered by the caregiver. The questions were asked in a structured interview format. The caregiver was interviewed by appropriate medical staff and asked questions about the subject in the third person.The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome).

Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 16 16 13
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.5  (7.0) -4.8  (8.0) -5.5  (6.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.200
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -3.20
Confidence Interval (2-Sided) 95%
-8.17 to 1.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.46
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.239
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -3.04
Confidence Interval (2-Sided) 95%
-8.19 to 2.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.55
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)
Hide Description The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 collects 8 items with 5 categories each (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always or cannot do at all). The total score was calculated by summing the scores of all applicable questions and convert the resulting sum to a summary index score between 0 and 100 by multiplying with 100/32. A negative value indicates an improvement.
Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 40 36 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.8  (14.0) -5.1  (20.4) -10.0  (15.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.519
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -2.09
Confidence Interval (2-Sided) 95%
-8.48 to 4.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -5.06
Confidence Interval (2-Sided) 95%
-11.29 to 1.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.15
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Sum Score of the Mood / Cognition Domain of the Nonmotor Symptom Assessment Scale (NMSS)
Hide Description

Nonmotor performance was assessed via the Nonmotor Symptom Assessment Scale (NMSS), an accepted scale that has been validated in an international study (Naidu et al, 2006; Chaudhuri et al, 2007), at the Baseline Visit as well as at the end of the Maintenance Period. The severity and frequency of the subject’s nonmotor symptoms were assessed by the investigator (or designee) in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; and miscellaneous.

Items are scored for severity (from 0 (none) to 3 (severe)) and frequency (from 1 (rarely) to 4 (very frequent )). The score was calculated as severity x frequency. The theoretical minimum is 0 (best possible outcome) and maximum total score is 360 points (worst possible outcome).

Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 39 32 39
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-4.6  (7.9) -9.8  (12.1) -9.8  (10.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -3.62
Confidence Interval (2-Sided) 95%
-7.39 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -3.88
Confidence Interval (2-Sided) 95%
-7.46 to -0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.80
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)
Hide Description The Snaith Hamilton Pleasure Scale (SHAPS) (Snaith et al, 1995) is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores range from 0 to 14. A higher score represents more anhedonic symptoms.
Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 40 36 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.5  (2.5) -1.3  (2.2) -0.9  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-1.16 to 0.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.74 to 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)
Hide Description The Beck Depression Inventory (BDI) is a self-report instrument to measure depression symptoms and severity (Beck et al, 1961). The BDI-II is a revised version of the scale in order to be more consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression (Beck et al, 1996). There are 21 items in the BDI-II, classified as cognitive-affective (Items 1-13) and somatic-performance (Items 14-21) subscales. The degree of severity is indicated on a 4-point scale; items are rated from 0 (not at all) to 3 (extreme form of each symptom). Scores of 0-13 indicate minimal depression, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression.
Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 39 31 39
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.3  (7.0) -2.9  (5.9) -3.7  (5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-2.34 to 2.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.785
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-2.68 to 2.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.19
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) in "on" State
Hide Description

Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit.

The UPDRS Part III (motor subscale) had to be measured in the “on” state and consisted of 27 items and sub items scored between 0 and 4. The sum score ranged between 0 and 108 and was calculated as sum of the 27 individual scores. If 1 or more items were missing and could not be substituted with a previous post-Baseline value, the sum score was also missing.

A negative value indicates an improvement.

Time Frame Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 40 36 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.4  (8.2) -8.9  (10.4) -8.1  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, Low Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -4.96
Confidence Interval (2-Sided) 95%
-8.91 to -1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine, High Dose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.
Method of Estimation Estimation Parameter Least Square Mean
Estimated Value -4.83
Confidence Interval (2-Sided) 95%
-8.63 to -1.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.92
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to the End of the Maintenance Period in the Score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness)
Hide Description

The Clinical Global Impression (CGI) scales (Guy and Bonato, 1970) were initially developed for a risk-benefit estimation within the treatment of mentally ill patients. The 4 global scales (severity of illness, change in severity from Baseline, therapeutic efficacy, and tolerability of treatment) are used as different measures of treatment outcome in different kinds of pharmacological studies.

The CGI Item 1 (severity of illness) collected 1 answer out of 8 categories (0-‘Not assessed’, 1-‘Normal, not at all ill’, 2-‘Borderline ill’, 3-‘Mildly ill’, 4-‘Moderately ill’, 5-‘Markedly ill’, 6-‘Severely ill’, and 7-‘Among the most extremely ill patients’) at each assessment. The category 0-‘Not assessed’ was considered as missing and therefore used neither for calculation nor for display purposes.

Time Frame Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description:

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Overall Number of Participants Analyzed 40 36 40
Measure Type: Number
Unit of Measure: participants
Normal, not ill at all 1 1 2
Borderline ill 6 2 3
Mildly ill 19 16 21
Moderately ill 9 10 12
Markedly ill 2 1 1
Severely ill 1 1 0
Amongst the most extremely ill subjects 0 0 0
Missing 2 5 1
Time Frame Treatment Emergent Adverse Events (TEAEs) were reported from Baseline up to the Safety Follow-up Visit (approximately during 19 weeks).
Adverse Event Reporting Description The Baseline Analysis Population refers to the Safety Set (SS). The SS includes all randomized subjects who received at least 1 dose of study medication.
 
Arm/Group Title Placebo Rotigotine, Low Dose Rotigotine, High Dose
Hide Arm/Group Description

Placebo transdermal patches

Placebo: Placebo, matching transdermal patches

Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

Optimal dosage:

The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Rotigotine: Rotigotine, transdermal patches:

10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)

Optimal dosage:

The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

All-Cause Mortality
Placebo Rotigotine, Low Dose Rotigotine, High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rotigotine, Low Dose Rotigotine, High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/40 (10.00%)      2/41 (4.88%)      1/41 (2.44%)    
Gastrointestinal disorders       
Small intestinal obstruction * 1  0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Abdominal pain * 1  1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Ileus * 1  0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Infections and infestations       
Abscess * 1  0/40 (0.00%)  0 1/41 (2.44%)  1 0/41 (0.00%)  0
Sepsis * 1  1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Nervous system disorders       
Cerebral haematoma * 1  0/40 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Cerebrovascular accident * 1  1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
Transient ischaemic attack * 1  1/40 (2.50%)  1 0/41 (0.00%)  0 0/41 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rotigotine, Low Dose Rotigotine, High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/40 (45.00%)      17/41 (41.46%)      15/41 (36.59%)    
Gastrointestinal disorders       
Constipation * 1  1/40 (2.50%)  1 2/41 (4.88%)  2 3/41 (7.32%)  3
Nausea * 1  4/40 (10.00%)  5 4/41 (9.76%)  5 2/41 (4.88%)  2
Dry mouth * 1  0/40 (0.00%)  0 0/41 (0.00%)  0 3/41 (7.32%)  3
General disorders       
Application site pruritus * 1  2/40 (5.00%)  2 4/41 (9.76%)  4 1/41 (2.44%)  2
Oedema peripheral * 1  1/40 (2.50%)  1 2/41 (4.88%)  2 3/41 (7.32%)  3
Injury, poisoning and procedural complications       
Fall * 1  2/40 (5.00%)  3 3/41 (7.32%)  3 2/41 (4.88%)  2
Nervous system disorders       
Somnolence * 1  3/40 (7.50%)  3 2/41 (4.88%)  2 4/41 (9.76%)  5
Dyskinesia * 1  2/40 (5.00%)  3 3/41 (7.32%)  3 1/41 (2.44%)  1
Headache * 1  4/40 (10.00%)  6 1/41 (2.44%)  1 3/41 (7.32%)  6
Psychiatric disorders       
Depression * 1  2/40 (5.00%)  2 4/41 (9.76%)  4 1/41 (2.44%)  1
Insomnia * 1  6/40 (15.00%)  6 1/41 (2.44%)  1 2/41 (4.88%)  2
Suicidal ideation * 1  3/40 (7.50%)  3 1/41 (2.44%)  1 1/41 (2.44%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
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.
Results Point of Contact
Name/Title: UCB Cares
Organization: UCB
Phone: +1 877 822 9493
Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01782222     History of Changes
Other Study ID Numbers: PD0005
2012-002840-26 ( EudraCT Number )
First Submitted: January 30, 2013
First Posted: February 1, 2013
Results First Submitted: December 15, 2014
Results First Posted: January 19, 2015
Last Update Posted: August 31, 2018