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

This study has been completed.
Information provided by:
Pfizer 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
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)

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 ]

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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00627003

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00627003     History of Changes
Other Study ID Numbers: CABAS-0067-033
Study First Received: February 19, 2008
Last Updated: April 22, 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 processed this record on August 17, 2017