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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00625547
First Posted: February 28, 2008
Last Update Posted: October 29, 2008
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.
Information provided by:
Pfizer
  Purpose
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.

Condition Intervention Phase
Restless Legs Syndrome Drug: cabergoline Drug: levodopa Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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 ]

Enrollment: 361
Study Start Date: January 2003
Study Completion Date: December 2004
Arms Assigned Interventions
Experimental: 1 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
Experimental: 2 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625547


  Show 50 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00625547     History of Changes
Other Study ID Numbers: CABAS-0067-031
First Submitted: February 19, 2008
First Posted: February 28, 2008
Last Update Posted: October 29, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Levodopa
Cabergoline
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents
Dopamine Agonists