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A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

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ClinicalTrials.gov Identifier: NCT00625547
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : October 29, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date October 29, 2008
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
  • Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS) [ Time Frame: Week 6 ]
  • Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
  • RLS quality-of-life questionnaire [ Time Frame: Weeks 6 and 30 ]
  • Clinical Global Impression [ Time Frame: Weeks 6 and 30 ]
  • Patient Global Impression [ Time Frame: Weeks 6 and 30 ]
  • Sleep questionnaire form A [ Time Frame: Weeks 6 and 30 ]
  • IRLSSG-RS [ Time Frame: Week 30 ]
  • Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram [ Time Frame: Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2 ]
  • Rating of severity of RLS at night (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ]
  • Rating of severity of RLS before bedtime (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ]
  • Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales) [ Time Frame: Weeks 6 and 30 ]
  • Global rating of quality of sleep (RLS-6 scale) [ Time Frame: Weeks 6 and 30 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
Official Title  ICMJE A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Brief Summary The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Restless Legs Syndrome
Intervention  ICMJE
  • Drug: cabergoline
    Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events
  • Drug: levodopa
    Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: cabergoline
  • Experimental: 2
    Intervention: Drug: levodopa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2008)
361
Original Actual Enrollment  ICMJE
 (submitted: February 27, 2008)
340
Actual Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
  • Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
  • No previous treatment for RLS or dissatisfaction with their current therapy

Exclusion Criteria:

  • Not available
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Sweden,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625547
Other Study ID Numbers  ICMJE CABAS-0067-031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP