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, Inc.
ClinicalTrials.gov Identifier:
NCT00519532
First received: August 21, 2007
Last updated: August 30, 2011
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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +18778229493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00519532     History of Changes
Other Study ID Numbers: SP915, EudraCT number: 2006-006907-35
Study First Received: August 21, 2007
Results First Received: March 17, 2010
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Spain: Spanish Agency of Medicines
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency
New Zealand: Medsafe
South Africa: Medicines Control Council
Australia: Department of Health and Ageing Therapeutic Goods Administration
Poland: Ministry of Health