Back to resultsAn Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
Primary Purpose
Advanced Stage Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Stage Parkinson's Disease focused on measuring Rotigotine, Neupro®
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rotigotine
Arm Description
Rotigotine
Outcomes
Primary Outcome Measures
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Secondary Outcome Measures
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Mean Epworth Sleepiness Scale Score During the Open-label Extension
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00501969
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Stage Parkinson's Disease
Keywords
Rotigotine, Neupro®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
395 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
Rotigotine
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro®
Intervention Description
Rotigotine trans-dermal patches once daily:
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)
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
five years
Secondary Outcome Measure Information:
Title
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
five years
Title
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Description
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.
Time Frame
Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
31 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
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