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Trial record 1 of 1 for:    NCT01300819
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Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms

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ClinicalTrials.gov Identifier: NCT01300819
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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 Other: Placebo
Drug: Rotigotine
Enrollment 349
Recruitment Details

The study was conducted in 71 sites spread across 12 countries, with 349 subjects randomized. The study duration per subject was up to 29 weeks.

The Participant Flow consists of patients in the Enrolled Set (ES). The Enrolled Set (ES) includes all subjects who signed the Informed Consent Form.

Pre-assignment Details Eligibility was assessed during the Screening Period, which lasted up to 4 weeks prior to the Baseline Visit. Eligible subjects returned for a Baseline Visit, during which all Baseline assessments were performed and then the subject was randomized to either Rotigotine or Placebo.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Period Title: Overall Study
Started 125 224
Completed 103 180
Not Completed 22 44
Reason Not Completed
Adverse Event             9             27
Lack of Efficacy             2             1
Withdrawal by Subject             10             12
Patient was 1 month late for Visit 10             0             1
Refusal to down titrate study drug             0             1
Administrative reason             0             1
Safety follow up not done by mistake             0             1
Follow up call was not done             1             0
Arm/Group Title Placebo Rotigotine Total
Hide Arm/Group Description

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Total of all reporting groups
Overall Number of Baseline Participants 125 224 349
Hide Baseline Analysis Population Description
Baseline characteristics are presented by the Randomized Set (RS), which is defined as all subjects that signed informed consent and were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 224 participants 349 participants
66.6  (9.8) 68.0  (9.4) 67.5  (9.6)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 224 participants 349 participants
< 65 years 51 74 125
>= 65 years 74 150 224
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 224 participants 349 participants
Female
58
  46.4%
95
  42.4%
153
  43.8%
Male
67
  53.6%
129
  57.6%
196
  56.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 224 participants 349 participants
France 3 6 9
Hungary 8 11 19
Czech Republic 8 13 21
Slovakia 15 28 43
Spain 12 23 35
Belgium 4 9 13
Romania 18 36 54
Austria 2 1 3
Bulgaria 30 51 81
Germany 15 24 39
Switzerland 1 3 4
Italy 9 19 28
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 125 participants 224 participants 349 participants
77.52  (14.90) 76.97  (13.66) 77.16  (14.10)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 125 participants 224 participants 349 participants
167.42  (10.17) 168.54  (8.56) 168.14  (9.17)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 125 participants 224 participants 349 participants
27.593  (4.505) 27.047  (4.348) 27.243  (4.406)
1.Primary Outcome
Title Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score
Hide Description The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent [daily or all the time]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-19.1  (24.2) -23.1  (23.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysing was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.58
Confidence Interval (2-Sided) 95%
-8.43 to 1.26
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score
Hide Description The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's Disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change from Baseline to end of Maintenance score indicates improvement.
Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 206
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.6  (8.3) -5.7  (8.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.60
Confidence Interval (2-Sided) 95%
-4.27 to -0.92
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)
Hide Description Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.
Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 116 204
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.6  (12.5) -5.9  (10.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments Two-sided p-values are presented.
Method ANCOVA
Comments Testing was performed using an ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.79
Confidence Interval (2-Sided) 95%
-5.21 to -0.37
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Cardiovascular (2 questions): range 0 - 24

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.2  (2.8) -1.1  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.773
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.67 to 0.50
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Sleep/Fatigue (4 questions): range 0-48

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.9  (5.9) -5.4  (7.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-2.41 to 0.29
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Mood/Cognition (6 questions): range 0 - 72

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-5.1  (10.0) -6.6  (11.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.81
Confidence Interval (2-Sided) 95%
-3.59 to -0.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Perception/Hallucinations (3 questions): range 0 - 36

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.2  (1.8) -0.2  (1.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.601
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.22 to 0.37
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Attention/Memory (3 questions): range 0 - 36

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.3  (4.8) -1.5  (4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.99 to 0.99
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Gastrointestinal tract (3 questions): range 0 - 36

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.4  (3.4) -1.6  (3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.584
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.87 to 0.49
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Urinary (3 questions): range 0 - 36

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.7  (6.6) -2.4  (6.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.536
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
-0.84 to 1.60
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Sexual function (2 questions): range 0 - 24

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.2  (4.2) -1.1  (4.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.889
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.81 to 0.94
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous
Hide Description

The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale.

The final score is derived from multiplying the severity score and the frequency score.

A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.

The possible min/max final scores per subdomain are calculated as follows:

Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain:

Subdomain Miscellaneous (4 questions): range 0 - 48

Time Frame From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description:

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Overall Number of Participants Analyzed 120 207
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.2  (4.4) -3.2  (5.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rotigotine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments Two-sided p-value is presented. No multiplicity adjustment is performed.
Method ANCOVA
Comments Analysis was performed with ANCOVA model, adjusted for several terms.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-2.06 to -0.03
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
Adverse Event Reporting Description The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
 
Arm/Group Title Placebo Rotigotine
Hide Arm/Group Description

Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours

Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.

Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.

All-Cause Mortality
Placebo Rotigotine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Rotigotine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/125 (3.20%)      8/223 (3.59%)    
Cardiac disorders     
Heart failure * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Tachycardia paroxysmal * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Artrial Fibrillation + Chest pain * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Exacerbation of chronic left sided heart insufficiency * 1  1/125 (0.80%)  1 0/223 (0.00%)  0
Gastrointestinal disorders     
Gastric ulcer * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
General disorders     
Death * 1  1/125 (0.80%)  1 0/223 (0.00%)  0
Infections and infestations     
Urinary tract infection * 1  1/125 (0.80%)  1 0/223 (0.00%)  0
Injury, poisoning and procedural complications     
Femur fracture * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Traumatic brain injury * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Musculoskeletal and connective tissue disorders     
Spinal column stenosis * 1  1/125 (0.80%)  1 0/223 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Nervous system disorders     
Acute cerebral infarction * 1  1/125 (0.80%)  1 0/223 (0.00%)  0
Hemiparesis * 1  1/125 (0.80%)  1 0/223 (0.00%)  0
Diabetic coma * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Worsening of Parkinson's Disease * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer * 1  1/125 (0.80%)  1 0/223 (0.00%)  0
Vascular disorders     
Deep vein thrombosis * 1  0/125 (0.00%)  0 1/223 (0.45%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rotigotine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/125 (16.80%)      66/223 (29.60%)    
Gastrointestinal disorders     
Nausea * 1  7/125 (5.60%)  8 27/223 (12.11%)  30
General disorders     
Application site pruritus * 1  2/125 (1.60%)  3 15/223 (6.73%)  16
Fatigue * 1  7/125 (5.60%)  8 9/223 (4.04%)  10
Nervous system disorders     
Somnolence * 1  7/125 (5.60%)  8 18/223 (8.07%)  21
Dizziness * 1  9/125 (7.20%)  9 15/223 (6.73%)  15
Headache * 1  5/125 (4.00%)  5 12/223 (5.38%)  14
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01300819    
Other Study ID Numbers: SP0976
2010-021394-37 ( EudraCT Number )
First Submitted: February 18, 2011
First Posted: February 23, 2011
Results First Submitted: October 25, 2013
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014