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

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ClinicalTrials.gov Identifier: NCT00627003
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : April 25, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Drug: Cabergoline Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)
Study Start Date : November 2002
Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 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
Experimental: 2 Other: Placebo
Placebo oral tablets administered daily for 5 weeks

Primary Outcome Measures :
  1. Sleep efficiency [ Time Frame: Week 5 ]
  2. PLMS-arousal index (PLMS-AI) [ Time Frame: Week 5 ]

Secondary Outcome Measures :
  1. Sleep Questionnaire Form A [ Time Frame: Weeks 2 and 5 ]
  2. Quality of Life for RLS questionnaire [ Time Frame: Weeks 2 and 5 ]
  3. Clinical Global Impressions [ Time Frame: Weeks 2 and 5 ]
  4. Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography [ Time Frame: Weeks 2 and 5 ]
  5. Total score of the severity rating scale of the International RLS (IRLS) Study Group [ Time Frame: Weeks 2 and 5 ]
  6. RLS-6 severity scales [ Time Frame: Weeks 2 and 5 ]

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

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

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): NCT00627003

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00627003     History of Changes
Other Study ID Numbers: CABAS-0067-033
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: April 25, 2011
Last Verified: April 2011

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