Clinical trial NCT00501969: An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
Official title: An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-Dopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Advanced Stage Parkinson's Disease
Keywords: Rotigotine
Neupro®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-07-17
Enrollment: 395
Sex: ALL
Minimum age (years): 31
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 advanced-stage idiopathic Parkinson's disease

Detailed description: This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Eligibility criteria: Inclusion Criteria:

* Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial

Exclusion Criteria:

* Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) 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: five years
Secondary outcomes:
measure: Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
timeFrame: five years
measure: Mean Epworth Sleepiness Scale Score During the Open-label Extension
timeFrame: Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)
Other outcomes:
Locations:
city: Bedford Park
country: Australia
city: Concord
country: Australia
city: Darlinghurst
country: Australia
city: East Gosford
country: Australia
city: Westmead
country: Australia
city: Innsbruck
country: Austria
city: Zagreb
country: Croatia
city: Brno
country: Czech Republic
city: Ostrava - Poruba
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha
country: Czech Republic
city: Oulu
country: Finland
city: Pori
country: Finland
city: Aix-en -Provence
country: France
city: Lille cedex
country: France
city: Lyon
country: France
city: Aachen
country: Germany
city: Bochum
country: Germany
city: Budapest
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Petach-Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Milano
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Pisa
country: Italy
city: Pozzilli
country: Italy
city: Roma
country: Italy
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Wellington
country: New Zealand
city: Bergen
country: Norway
city: Stavanger
country: Norway
city: Tonsberg
country: Norway
city: Trondheim
country: Norway
city: Gdansk
country: Poland
city: Krakow
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: Tygerberg
country: South Africa
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: San Sebastian
country: Spain
city: Stockholm
country: Sweden
city: Blackpool
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: