Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00498186
First received: July 6, 2007
Last updated: October 14, 2011
Last verified: October 2011
Results First Received: March 23, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Restless Legs Syndrome
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 295 subjects belong to the Enrolled Set (ES) and all of them received at least one dose of trial medication, so they all belong to the Safety Set (SS).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow information and Baseline Characteristics belong to the Safety Set (SS).

Reporting Groups
  Description
Rotigotine Rotigotine trans-dermal patch

Participant Flow:   Overall Study
    Rotigotine  
STARTED     295  
COMPLETED     122  
NOT COMPLETED     173  
Protocol Violation                 10  
Lack of Efficacy                 31  
Adverse Event                 89  
Unsatisfactory compliance of subject                 12  
Withdrawal by Subject                 18  
Lost to Follow-up                 3  
Unknown                 10  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rotigotine Rotigotine trans-dermal patch

Baseline Measures
    Rotigotine  
Number of Participants  
[units: participants]
  295  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     208  
>=65 years     87  
Age  
[units: years]
Mean ± Standard Deviation
  58.3  ± 10.1  
Gender  
[units: participants]
 
Female     196  
Male     99  
Body Mass Index (BMI) [1]
[units: kg/ m^2]
Mean ± Standard Deviation
  26.37  ± 3.84  
Height  
[units: cm]
Mean ± Standard Deviation
  167.5  ± 8.3  
Weight  
[units: kilogram (kg)]
Mean ± Standard Deviation
  74.21  ± 13.19  
[1] BMI= weight/height^2



  Outcome Measures
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1.  Primary:   Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.   [ Time Frame: Up to five years ]

2.  Secondary:   Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension   [ Time Frame: Up to five years ]


  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
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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.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00498186     History of Changes
Other Study ID Numbers: SP710
Study First Received: July 6, 2007
Results First Received: March 23, 2010
Last Updated: October 14, 2011
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines