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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00627003

Enrollment

Registered

2008-02-29

Start date

2002-11-30

Completion date

2003-05-31

Last updated

2011-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome

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.

Interventions

DRUGCabergoline

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

OTHERPlacebo

Placebo oral tablets administered daily for 5 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Sleep Questionnaire Form A	Weeks 2 and 5
RLS-6 severity scales	Weeks 2 and 5
Total score of the severity rating scale of the International RLS (IRLS) Study Group	Weeks 2 and 5
Quality of Life for RLS questionnaire	Weeks 2 and 5

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026