Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
- Registration Number
- NCT01300819
- Lead Sponsor
- UCB Pharma
- Brief Summary
The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
- Subject is male or female, ≥18 years of age
- Subject has idiopathic Parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of Parkinsonism
- Subject has a Hoehn and Yahr stage score ≤4
- Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40
- If the subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit
- If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study
- Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
- Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-A (MAO-A) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs)
- Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study
- Subject has evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview at the Screening Visit (Visit 1), confirmed by a positive structured clinical interview
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Rotigotine Rotigotine -
- Primary Outcome Measures
Name Time Method Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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.
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) From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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.
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 - 24Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 0-48Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 - 72Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 - 36Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory, From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 - 36Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 - 36Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 - 36Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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 - 24Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous From Baseline (Day 1) to end of 12-week Maintenance (Day 84) 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
Trial Locations
- Locations (87)
49
🇧🇬Sofia, Bulgaria
26
🇨🇭Sargans, Switzerland
222
🇨🇿Ostrava-Poruba, Czech Republic
243
🇸🇰Bratislava, Slovakia
249
🇸🇰Dolni Kubin, Slovakia
250
🇸🇰Krompachy, Slovakia
244
🇸🇰Lucenec, Slovakia
107
🇦🇹Wien, Austria
44
🇧🇬Plovdiv, Bulgaria
242
🇸🇰Bratislava, Slovakia
52
🇧🇬Russe, Bulgaria
233
🇨🇿Praha, Czech Republic
41
🇧🇬Sofia, Bulgaria
45
🇧🇬Sofia, Bulgaria
42
🇧🇬Varna, Bulgaria
181
🇫🇷Amiens, France
186
🇫🇷Limoges, France
62
🇩🇪Berlin, Germany
48
🇧🇬Sofia, Bulgaria
53
🇧🇬Sofia, Bulgaria
121
🇧🇪Brugge, Belgium
125
🇧🇪Antwerpen, Belgium
122
🇧🇪Brussels, Belgium
124
🇧🇪Gent, Belgium
131
🇧🇪Liege, Belgium
227
🇨🇿Litomysl, Czech Republic
232
🇨🇿Chomutov, Czech Republic
189
🇫🇷Aix-en Provence, France
67
🇩🇪Bochum, Germany
185
🇫🇷Pessac, France
77
🇩🇪Berlin, Germany
269
🇮🇹Treviso, Italy
148
🇪🇸Madrid, Spain
207
🇷🇴Brasov, Romania
158
🇪🇸Oviedo, Spain
141
🇪🇸Sant Cugat (Barcelona), Spain
147
🇪🇸Madrid, Spain
101
🇦🇹Feldbach, Austria
104
🇦🇹Wien, Austria
231
🇨🇿Plzen, Czech Republic
183
🇫🇷Toulouse, France
184
🇫🇷Roanne, France
80
🇩🇪Böblingen, Germany
61
🇩🇪Marburg, Germany
79
🇩🇪Oldenburg, Germany
114
🇩🇪Stuttgart, Germany
65
🇩🇪Ulm, Germany
73
🇩🇪Westerstede, Germany
87
🇭🇺Budapest, Hungary
88
🇭🇺Budapest, Hungary
89
🇭🇺Miskolc, Hungary
95
🇭🇺Gyor, Hungary
81
🇭🇺Nyiregyhaza, Hungary
84
🇭🇺Pecs, Hungary
86
🇭🇺Szeged, Hungary
254
🇮🇹Arcugnano, Italy
267
🇮🇹Chieti Scalo, Italy
270
🇮🇹Napoli, Italy
266
🇮🇹Perugia, Italy
264
🇮🇹Pisa, Italy
257
🇮🇹Pozzilli, Italy
262
🇮🇹Roma, Italy
258
🇮🇹Varese, Italy
252
🇮🇹Venezia, Italy
255
🇮🇹Verona, Italy
201
🇷🇴Bucuresti, Romania
203
🇷🇴Clluj-Napoca, Romania
213
🇷🇴Bucuresti, Romania
211
🇷🇴Cluj-Napoca, Romania
208
🇷🇴Sibiu, Romania
217
🇷🇴Sibiu, Romania
204
🇷🇴Timisoara, Romania
212
🇷🇴Targu Mures, Romania
245
🇸🇰Banska Bystrica, Slovakia
209
🇷🇴Timisoara, Romania
247
🇸🇰Banska Bystrica, Slovakia
240
🇸🇰Bratislava, Slovakia
157
🇪🇸Alicante, Spain
248
🇸🇰Zilina, Slovakia
146
🇪🇸Barcelona, Spain
142
🇪🇸Barcelona, Spain
143
🇪🇸Madrid, Spain
145
🇪🇸Madrid, Spain
152
🇪🇸Santiago de Compostela, Spain
24
🇨🇭Lugano, Switzerland
21
🇨🇭St. Gallen, Switzerland
22
🇨🇭Zuerich, Switzerland