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A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627003
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : April 25, 2011
Information provided by:

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 29, 2008
Last Update Posted Date April 25, 2011
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • Sleep efficiency [ Time Frame: Week 5 ]
  • PLMS-arousal index (PLMS-AI) [ Time Frame: Week 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00627003 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2008)
  • Sleep Questionnaire Form A [ Time Frame: Weeks 2 and 5 ]
  • Quality of Life for RLS questionnaire [ Time Frame: Weeks 2 and 5 ]
  • Clinical Global Impressions [ Time Frame: Weeks 2 and 5 ]
  • Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography [ Time Frame: Weeks 2 and 5 ]
  • Total score of the severity rating scale of the International RLS (IRLS) Study Group [ Time Frame: Weeks 2 and 5 ]
  • RLS-6 severity scales [ Time Frame: Weeks 2 and 5 ]
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 Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study 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 placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.
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 administered once daily in the evening: 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, followed by a stable dose for an additional 3 weeks
  • Other: Placebo
    Placebo oral tablets administered daily for 5 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Cabergoline
  • Experimental: 2
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2011)
Original Actual Enrollment  ICMJE
 (submitted: February 19, 2008)
Actual Study Completion Date  ICMJE May 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Idiopathic RLS
  • Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
  • In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time

Exclusion Criteria:

  • Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS
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 Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00627003
Other Study ID Numbers  ICMJE CABAS-0067-033
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 Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

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