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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

This study has been terminated.
(Due to clinical trial supplies shortage)
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00519532
First received: August 21, 2007
Last updated: October 17, 2014
Last verified: September 2010
Results First Received: March 17, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: Drug: Rotigotine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 84 subjects belong to the Enrolled Set (ES) and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 83 subjects belong to the Full Analysis Set (FAS).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow information belong to the Enrolled Set (ES). Baseline Characteristics are described for the Full Analysis Set (FAS).

Reporting Groups
  Description
Rotigotine Rotigotine Transdermal Patch

Participant Flow:   Overall Study
    Rotigotine  
STARTED     84  
COMPLETED     66  
NOT COMPLETED     18  
Adverse Event                 11  
Withdrawal by Subject                 5  
Lost to Follow-up                 2  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in UPDRS III Score at Week 13 (End of Maintenance)   [ Time Frame: Baseline (baseline SP915) and week 13 (End of maintenance) ]

2.  Primary:   Change From Baseline in Parkinson Disease Sleep Scale (PDSS) at Week 13 (End of Maintenance)   [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ]

3.  Secondary:   Change From Baseline in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) at Week 13 (End of Maintenance)   [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ]

4.  Secondary:   Change From Baseline in Number of Nocturias at Week 13 (End of Maintenance)   [ Time Frame: Baseline (baseline SP889 NCT00474058) and week 13 (End of maintenance) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


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