Study Stopped
Due to clinical trial supplies shortage
Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease
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
2 other identifiers
interventional
84
11 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2007
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
April 2, 2010
CompletedOctober 27, 2014
September 1, 2010
1.8 years
August 21, 2007
March 17, 2010
October 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline (baseline SP915) and week 13 (End of maintenance)
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.
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Secondary Outcomes (2)
Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)
Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance)
Study Arms (1)
Rotigotine
EXPERIMENTALRotigotine Transdermal Patch
Interventions
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
Eligibility Criteria
You may qualify if:
- Completion of trial SP889
You may not qualify if:
- Ongoing serious adverse event assessed as related to trial medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (21)
Unknown Facility
St. Petersburg, Florida, 33701, United States
Unknown Facility
Salisbury, North Carolina, 28144, United States
Unknown Facility
Concord, Australia
Unknown Facility
Oulu, 90220, Finland
Unknown Facility
Berlin, 10713, Germany
Unknown Facility
Dresden, 01307, Germany
Unknown Facility
Kassel, 34128, Germany
Unknown Facility
Marburg, 35039, Germany
Unknown Facility
Naumburg, 06618, Germany
Unknown Facility
Ulm, 89081, Germany
Unknown Facility
Budapest, 1145, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Chieti, Italy
Unknown Facility
Milan, 20127, Italy
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Olyszytn, Poland
Unknown Facility
Cape Town, South Africa
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Lancashire, United Kingdom
Unknown Facility
Liverpool, L9 7JL, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Because the manufacturing process for rotigotine patches was changed, enrollment into SP915 was stopped in April 2008 to ensure sufficient trial medication for all subjects enrolled at that time to complete the trial according to the protocol.
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 22, 2007
Study Start
July 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
October 27, 2014
Results First Posted
April 2, 2010
Record last verified: 2010-09