An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

August 31, 2002

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Early Stage Parkinson's Disease
Interventions
DRUG

Rotigotine

"Rotigotine trans-dermal patches, once daily:~10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours); 50 cm2 (10 mg/24 hours); 60 cm2 (12 mg/24 hours); 70 cm2 (14 mg/24 hours); 80 cm2 (16 mg/24 hours);~Optimal dosing:~During the first year: The maximum Rotigotine dose allowed is 8 mg/24 hours.~After the first year: allowed dose increase of rotigotine up to a maximum of 16 mg/24 hours."

Trial Locations (63)

Unknown

Concord

Darlinghurst

East Gosford

Westmead

Innsbruck

Vienna

Brussels

Hoboken

Zagreb

Brno

Ostrava

Pilsen

Espoo

Kuopio

Lappeenranta

Oulu

Pori

Aix-en-Provence

Caen

Toulouse

Aachen

Dresden

Kiel

Marburg

Budapest

Miskolc

Pécs

Hadera

Petah Tikva

Tel Aviv

Milan

Padua

Pozzilli

Breda

Geldrop

Auckland

Christchurch

North Shore

Wellington

Stavanger

Trondheim

Gdansk

Katowice

Krakόw

Lublin

Mosina k/Poznania

Olsztyn

Warsaw

Cape Town

Pretoria

Barcelona

Pamplona

Karlstad

Stockholm

Bern

Lausanne

Birmingham

Blackpool

Glasgow

Liverpool

London

Newcastle upon Tyne

Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

UCB Pharma

INDUSTRY

NCT00599196 - An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease | Biotech Hunter | Biotech Hunter