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

This study has been completed.
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ClinicalTrials.gov Identifier:
First received: February 19, 2008
Last updated: April 22, 2011
Last verified: April 2011
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 Intervention Phase
Restless Legs Syndrome
Drug: Cabergoline
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study 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:
  • Sleep efficiency [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • PLMS-arousal index (PLMS-AI) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep Questionnaire Form A [ Time Frame: Weeks 2 and 5 ] [ Designated as safety issue: No ]
  • Quality of Life for RLS questionnaire [ Time Frame: Weeks 2 and 5 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions [ Time Frame: Weeks 2 and 5 ] [ Designated as safety issue: No ]
  • Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography [ Time Frame: Weeks 2 and 5 ] [ Designated as safety issue: No ]
  • Total score of the severity rating scale of the International RLS (IRLS) Study Group [ Time Frame: Weeks 2 and 5 ] [ Designated as safety issue: No ]
  • RLS-6 severity scales [ Time Frame: Weeks 2 and 5 ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: November 2002
Study Completion Date: May 2003
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00627003

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

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 
Study First Received: February 19, 2008
Last Updated: April 22, 2011
Health Authority: Germany: Bundesinstitute fur Arzneimittel und Medicinprodukte

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

ClinicalTrials.gov processed this record on April 27, 2016