Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease
2 other identifiers
interventional
349
12 countries
87
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2011
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
May 9, 2014
CompletedMay 9, 2014
April 1, 2014
1.7 years
February 18, 2011
October 25, 2013
April 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score
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.
From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
Secondary Outcomes (11)
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)
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)
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)
Change 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)
Change 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)
- +6 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORRotigotine
EXPERIMENTALInterventions
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 was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose was 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
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 was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was 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 was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (87)
101
Feldbach, Austria
104
Vienna, Austria
107
Vienna, Austria
125
Antwerp, Belgium
121
Bruges, Belgium
122
Brussels, Belgium
124
Ghent, Belgium
131
Liège, Belgium
44
Plovdiv, Bulgaria
52
Rousse, Bulgaria
41
Sofia, Bulgaria
45
Sofia, Bulgaria
48
Sofia, Bulgaria
49
Sofia, Bulgaria
53
Sofia, Bulgaria
42
Varna, Bulgaria
232
Chomutov, Czechia
227
Litomyšl, Czechia
222
Ostrava-Poruba, Czechia
231
Pilsen, Czechia
233
Prague, Czechia
189
Aix-en-Provence, France
181
Amiens, France
186
Limoges, France
185
Pessac, France
184
Roanne, France
183
Toulouse, France
62
Berlin, Germany
77
Berlin, Germany
67
Bochum, Germany
80
Böblingen, Germany
61
Marburg, Germany
79
Oldenburg, Germany
114
Stuttgart, Germany
65
Ulm, Germany
73
Westerstede, Germany
87
Budapest, Hungary
88
Budapest, Hungary
95
Győr, Hungary
89
Miskolc, Hungary
81
Nyíregyháza, Hungary
84
Pécs, 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
269
Treviso, Italy
258
Varese, Italy
252
Venezia, Italy
255
Verona, Italy
207
Brasov, Romania
201
Bucharest, Romania
213
Bucharest, Romania
203
Clluj-Napoca, Romania
211
Cluj-Napoca, Romania
208
Sibiu, Romania
217
Sibiu, Romania
212
Târgu Mureş, Romania
204
Timișoara, Romania
209
Timișoara, Romania
245
Banská Bystrica, Slovakia
247
Banská Bystrica, Slovakia
240
Bratislava, Slovakia
242
Bratislava, Slovakia
243
Bratislava, Slovakia
249
Dolný Kubín, Slovakia
250
Krompachy, Slovakia
244
Lučenec, Slovakia
248
Žilina, Slovakia
157
Alicante, Spain
142
Barcelona, Spain
146
Barcelona, Spain
143
Madrid, Spain
145
Madrid, Spain
147
Madrid, Spain
148
Madrid, Spain
158
Oviedo, Spain
141
Sant Cugat (Barcelona), Spain
152
Santiago de Compostela, Spain
24
Lugano, Switzerland
21
Sankt Gallen, Switzerland
26
Sargans, Switzerland
22
Zurich, Switzerland
Related Publications (1)
Antonini A, Bauer L, Dohin E, Oertel WH, Rascol O, Reichmann H, Schmid M, Singh P, Tolosa E, Chaudhuri KR. Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol. 2015 Oct;22(10):1400-7. doi: 10.1111/ene.12757. Epub 2015 Jun 22.
PMID: 26095948DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 23, 2011
Study Start
February 1, 2011
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
May 9, 2014
Results First Posted
May 9, 2014
Record last verified: 2014-04