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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ClinicalTrials.gov Identifier: NCT00519532 |
Recruitment Status
:
Terminated
(Due to clinical trial supplies shortage)
First Posted
: August 22, 2007
Results First Posted
: April 2, 2010
Last Update Posted
: October 27, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | August 21, 2007 | |||
First Posted Date ICMJE | August 22, 2007 | |||
Results First Submitted Date | March 17, 2010 | |||
Results First Posted Date | April 2, 2010 | |||
Last Update Posted Date | October 27, 2014 | |||
Study Start Date ICMJE | July 2007 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Change in motor function, sleep quality and non-motor symptoms over the course of the trial [ Time Frame: baseline to end of maintenance ] | |||
Change History | Complete list of historical versions of study NCT00519532 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Change in Pain; Depression; Safety variables [ Time Frame: baseline to end of maintenance ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's Disease | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Parkinson's Disease | |||
Intervention ICMJE | Drug: Rotigotine
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 Other Name: Neupro® |
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Study Arms | Experimental: Rotigotine
Rotigotine Transdermal Patch
Intervention: Drug: Rotigotine |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
84 | |||
Original Estimated Enrollment ICMJE |
270 | |||
Actual Study Completion Date | May 2009 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Finland, Germany, Hungary, Italy, New Zealand, Poland, South Africa, Spain, United Kingdom, United States | |||
Removed Location Countries | Austria | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00519532 | |||
Other Study ID Numbers ICMJE | SP0915 EudraCT number: 2006-006907-35 ( Other Identifier: EudraCT ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | UCB Pharma | |||
Study Sponsor ICMJE | UCB Pharma | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | UCB Pharma | |||
Verification Date | September 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |