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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Other: Placebo; Drug: Cabergoline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627003

CABAS-0067-033

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Cabergoline

2

Experimental group

Treatment:

Other: Placebo