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

A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)

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.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Drug: Cabergoline; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sleep efficiency	Week 5
PLMS-arousal index (PLMS-AI)	Week 5

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Study Completion (ACTUAL): May 1, 2003

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (ESTIMATE): February 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 25, 2011
• Last Update Submitted That Met QC Criteria: April 22, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cabergoline
• Other Study ID Numbers: CABAS-0067-033