Back to resultsLong-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rotigotine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Neupro®, Rotigotine, Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Completion of trial SP889
Exclusion Criteria:
- Ongoing serious adverse event assessed as related to trial medication
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rotigotine
Arm Description
Rotigotine Transdermal Patch
Outcomes
Primary Outcome Measures
Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
Baseline is defined as first titration visit (T1) of SP915.
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Secondary Outcome Measures
Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
The change in number of nocturias was used to evaluate improvements in sleep disorders.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519532
Brief Title
Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
Official Title
A Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
Due to clinical trial supplies shortage
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (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 long-term effect of the 24-hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non-motor symptoms of Parkinson's disease. The long-term safety and tolerability of the rotigotine transdermal patch will also be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Neupro®, Rotigotine, Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotigotine
Arm Type
Experimental
Arm Description
Rotigotine Transdermal Patch
Intervention Type
Drug
Intervention Name(s)
Rotigotine
Other Intervention Name(s)
Neupro®
Intervention Description
Rotigotine transdermal patches:
10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
Optimal dosing: The maximum rotigotine dose allowed is 16mg/24h
Primary Outcome Measure Information:
Title
Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)
Description
The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the elements in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities.
Baseline is defined as first titration visit (T1) of SP915.
Time Frame
Baseline (baseline SP915) and week 13 (End of maintenance)
Title
Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)
Description
The Parkinson Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores range between 0= never and 4= very often.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Time Frame
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Secondary Outcome Measure Information:
Title
Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
Description
Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Time Frame
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Title
Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
Description
The change in number of nocturias was used to evaluate improvements in sleep disorders.
Baseline is defined as Visit 2 of previous double- blind trial SP889.
Time Frame
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of trial SP889
Exclusion Criteria:
Ongoing serious adverse event assessed as related to trial 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
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Concord
Country
Australia
City
Oulu
ZIP/Postal Code
90220
Country
Finland
City
Berlin
ZIP/Postal Code
10713
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Kassel
ZIP/Postal Code
34128
Country
Germany
City
Marburg
ZIP/Postal Code
35039
Country
Germany
City
Naumburg
ZIP/Postal Code
06618
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Chieti
Country
Italy
City
Milano
ZIP/Postal Code
20127
Country
Italy
City
Christchurch
Country
New Zealand
City
Olyszytn
Country
Poland
City
Cape Town
Country
South Africa
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Lancashire
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7JL
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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Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
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