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Long-term Study Of Ropinirole In Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00329602
First received: May 23, 2006
Last updated: March 15, 2012
Last verified: March 2011
History of Changes
Results First Received: September 10, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Interventions: Drug: Placebo
Drug: Ropinirole

  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
Participants (par.) could enter the Open-Label (OL) phase at the end of the Double-Blind (DB) phase. If a par. did not complete the DB phase due to lack of efficacy, he/she could also be considered for entry into the OL phase if the investigator considered it appropriate and the par. met the protocol-defined criteria in describing lack of efficacy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Double-blind Placebo Matching placebo tablets
Double-blind Ropinirole IR Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
Open-label Ropinirole IR Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day

Participant Flow for 2 periods

 Period 1:   26-Week Double-Blind Treatment Phase
    Double-blind Placebo     Double-blind Ropinirole IR     Open-label Ropinirole IR  
STARTED     207 [1]   197     0  
COMPLETED     88     98     0  
NOT COMPLETED     119     99     0  
Did not complete phase; reason unknown                 119                 99                 0  
[1] Numbers of participants in the "Participant Flow" section are based on the Safety Population.

Period 2:   40-Week Open-Label Treatment Phase
    Double-blind Placebo     Double-blind Ropinirole IR     Open-label Ropinirole IR  
STARTED     0     0     269 [1]
COMPLETED     0     0     233  
NOT COMPLETED     0     0     36  
Adverse Event                 0                 0                 20  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 0                 0                 2  
Lack of Efficacy                 0                 0                 9  
Captured as Other                 0                 0                 4  
[1] 148 and 121 par. randomized to DB placebo and ropinirole IR, respectively, entered the OL phase.



  Baseline Characteristics
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Reporting Groups
  Description
Double-Blind Placebo Matching placebo tablets
Double-Blind Ropinirole IR Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
Total Total of all reporting groups

Baseline Measures
    Double-Blind Placebo     Double-Blind Ropinirole IR     Total  
Number of Participants  
[units: participants]
 		  207     197     404  
Age [1]
[units: years]
Mean ± Standard Deviation 		  55.9  ± 11.53     56.5  ± 11.97     56.2  ± 11.73  
Gender [1]
[units: participants]
 		     
Female     132     124     256  
Male     75     73     148  
Race/Ethnicity, Customized [1]
[units: participants]
 		     
White     204     197     401  
Asian     2     0     2  
Hawaiian or other Pacific Islander     1     0     1  
[1] The Safety Population, comprised of all participants who received at least one dose of study medication, was used for all demographic characteristics.



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26   [ Time Frame: Baseline and Weeks 12 and 26 ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Clinically Meaningful Augmentation and Early Morning Rebound (EMR) Cases   [ Time Frame: During 15-month study duration at scheduled (Weeks 16, 20, 26, or early withdrawal for DB phase; Weeks 39, 47, 55, 63, 67, or early withdrawal for the OL phase) and unscheduled (26-week DB phase and 40-week OL phase) visits ]
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3.  Secondary:   Mean Change From Baseline in the International RLS (IRLS) Rating Scale Total Score at Weeks 1, 4, 8, 16, and 20   [ Time Frame: Baseline and Weeks 1, 4, 8, 16, and 20 ]
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4.  Secondary:   Change From Baseline in the Domains of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Weeks 12 and 26   [ Time Frame: Baseline and Weeks 12 and 26 ]
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5.  Secondary:   Change From Baseline in Sleep Quantity, a Domain of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale, at Weeks 12 and 26   [ Time Frame: Baseline and Weeks 12 and 26 ]
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6.  Secondary:   Change From Baseline in the Johns Hopkins RLS Quality of Life (RLS QoL) Questionnaire Overall Life Impact Score at Weeks 12 and 26   [ Time Frame: Baseline and Weeks 12 and 26 ]
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7.  Secondary:   Change From Baseline in the Domains of the MOS 36-item Short Form Health Survey (SF-36) at Weeks 12 and 26   [ Time Frame: Baseline and Weeks 12 and 26 ]
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8.  Secondary:   Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 1, 12 and 26   [ Time Frame: Weeks 1, 12 and 26 ]
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9.  Secondary:   Number of Participants Withdrawing Due to Lack of Efficacy During the First 26 Weeks of the Study   [ Time Frame: Baseline to Week 26 ]
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10.  Secondary:   Number of Participants Rated as Normal or Borderline Ill on the CGI Severity of Illness (CGI-S) Scale at Week 26   [ Time Frame: Week 26 ]
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11.  Secondary:   Median Time to First CGI-I Response of Much/Very Much Improved During the Double-blind Phase   [ Time Frame: Baseline to Week 26 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With a Score of Much/Very Much Improved on the CGI-I Scale at Week 67   [ Time Frame: Week 67 ]
  Show Outcome Measure 12

13.  Secondary:   Mean Change From Baseline in the IRLS Rating Scale Total Score at Week 67   [ Time Frame: Baseline and Week 67 ]
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14.  Post-Hoc:   Post-hoc Analysis of Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26, Exploring the Impact of Center Group on Treatment Effect   [ Time Frame: Baseline and Weeks 12 and 26 ]
  Show Outcome Measure 14

15.  Post-Hoc:   Post-hoc Analysis of Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 12 and 26, Exploring the Impact of Center Group on Treatment Effect   [ Time Frame: Weeks 12 and 26 ]
  Show Outcome Measure 15


  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
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00329602     History of Changes
Other Study ID Numbers: ROR104836
Study First Received: May 23, 2006
Results First Received: September 10, 2009
Last Updated: March 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices