Clinical trial NCT00599196: An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
Official title: An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early Stage Parkinson's Disease
Keywords: Rotigotine
Neupro®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-01-23
Enrollment: 381
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

Detailed description: This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Eligibility criteria: Inclusion Criteria:

* Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial

Exclusion Criteria:

* Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
timeFrame: six years
Secondary outcomes:
measure: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
timeFrame: six years
measure: Mean Epworth Sleepiness Scale Score During the Open-label Extension
timeFrame: Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)
Other outcomes:
Locations:
city: Concord
country: Australia
city: Darlinghurst
country: Australia
city: East Gosford
country: Australia
city: Westmead
country: Australia
city: Innsbruck
country: Austria
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Hoboken
country: Belgium
city: Zagreb
country: Croatia
city: Brno
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Espoo
country: Finland
city: Kuopio
country: Finland
city: Lappeenranta
country: Finland
city: Oulu
country: Finland
city: Pori
country: Finland
city: Aix-en -Provence
country: France
city: Caen Cedex
country: France
city: Toulouse Cedex
country: France
city: Aachen
country: Germany
city: Dresden
country: Germany
city: Kiel
country: Germany
city: Marburg
country: Germany
city: Budapest
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Hadera
country: Israel
city: Petach-Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Milano
country: Italy
city: Padova
country: Italy
city: Pozzilli
country: Italy
city: Breda
country: Netherlands
city: Geldrop
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: North Shore
country: New Zealand
city: Wellington
country: New Zealand
city: Stavanger
country: Norway
city: Trondheim
country: Norway
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakόw
country: Poland
city: Lublin
country: Poland
city: Mosina k/Poznania
country: Poland
city: Olsztyn
country: Poland
city: Warszawa
country: Poland
city: Cape Town
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Pamplona
country: Spain
city: Karlstad
country: Sweden
city: Stockholm
country: Sweden
city: Bern
country: Switzerland
city: Lausanne
country: Switzerland
city: Birmingham
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Giladi N, Boroojerdi B, Surmann E. The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson's disease. J Neural Transm (Vienna). 2013 Sep;120(9):1321-9. doi: 10.1007/s00702-013-1001-5. Epub 2013 Mar 19.