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Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine (RECOVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00474058
First received: May 14, 2007
Last updated: October 14, 2011
Last verified: October 2011
History of Changes
Results First Received: February 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Interventions: Drug: Rotigotine
Other: Placebo

  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 333 subjects were enrolled in this trial and comprised the Enrolled Set (ES). 287 subjects were randomized and all of them received at least 1 dose of trial medication, so they all belong to the Safety Set (SS). 267 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 shows all 287 subjects who has been enrolled and randomized. Baseline Characteristics are described for the Full Analysis Set (FAS).

Reporting Groups
  Description
Rotigotine Rotigotine transdermal patch
Placebo Placebo transdermal patch

Participant Flow:   Overall Study
    Rotigotine     Placebo  
STARTED     190     97  
COMPLETED     166     80  
NOT COMPLETED     24     17  
Adverse Event                 11                 6  
Lack of Efficacy                 0                 4  
Withdrawal by Subject                 11                 7  
Unknown                 2                 0  



  Baseline Characteristics
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  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Early Morning UPDRS Part III Score   [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  Show Outcome Measure 1

2.  Primary:   Change in Parkinson's Disease Sleep Scale (PDSS)   [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  Show Outcome Measure 2

3.  Secondary:   Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)   [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  Show Outcome Measure 3

4.  Secondary:   Change in Number of Nocturias   [ Time Frame: From baseline to end of maintenance (after 4 weeks maintenance) ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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
During the course of the trial, the manufacturing process for rotigotine was changed. At that time, the expiry date for trial medication was Apr 2009, recruitment for SP889 had to be stopped effective on 17 Nov 2008.  


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1877 822 9493


Publications of Results:

Publications automatically indexed to this study:


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00474058     History of Changes
Other Study ID Numbers: SP889, EudraCT No.: 2006-006752-35
Study First Received: May 14, 2007
Results First Received: February 25, 2010
Last Updated: October 14, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
New Zealand: Medsafe
Poland: Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency