Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms

PHASE4CompletedINTERVENTIONAL
Enrollment

349

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

November 30, 2012

Conditions
Idiopathic Parkinson's Disease
Interventions
OTHER

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."

DRUG

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."

Trial Locations (87)

Unknown

101, Feldbach

104, Vienna

107, Vienna

125, Antwerp

121, Bruges

122, Brussels

124, Ghent

131, Liège

44, Plovdiv

52, Rousse

41, Sofia

45, Sofia

48, Sofia

49, Sofia

53, Sofia

42, Varna

232, Chomutov

227, Litomyšl

222, Ostrava-Poruba

231, Pilsen

233, Prague

189, Aix-en-Provence

181, Amiens

186, Limoges

185, Pessac

184, Roanne

183, Toulouse

62, Berlin

77, Berlin

67, Bochum

80, Böblingen

61, Marburg

79, Oldenburg

114, Stuttgart

65, Ulm

73, Westerstede

87, Budapest

88, Budapest

95, Győr

89, Miskolc

81, Nyíregyháza

84, Pécs

86, Szeged

254, Arcugnano

267, Chieti Scalo

270, Napoli

266, Perugia

264, Pisa

257, Pozzilli

262, Roma

269, Treviso

258, Varese

252, Venezia

255, Verona

207, Brasov

201, Bucharest

213, Bucharest

203, Clluj-Napoca

211, Cluj-Napoca

208, Sibiu

217, Sibiu

212, Târgu Mureş

204, Timișoara

209, Timișoara

245, Banská Bystrica

247, Banská Bystrica

240, Bratislava

242, Bratislava

243, Bratislava

249, Dolný Kubín

250, Krompachy

244, Lučenec

248, Žilina

157, Alicante

142, Barcelona

146, Barcelona

143, Madrid

145, Madrid

147, Madrid

148, Madrid

158, Oviedo

141, Sant Cugat (Barcelona)

152, Santiago de Compostela

24, Lugano

21, Sankt Gallen

26, Sargans

22, Zurich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY