Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
NCT ID: NCT01300819
Last Updated: 2014-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
349 participants
INTERVENTIONAL
2011-02-28
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
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 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
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 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.
Interventions
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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 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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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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
Countries
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References
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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.
Related Links
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FDA safety Alerts and Recalls
Other Identifiers
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2010-021394-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0976
Identifier Type: -
Identifier Source: org_study_id
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