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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Restless Legs Syndrome

Intervention: Cabergoline (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome:

Sleep efficiency

PLMS-arousal index (PLMS-AI)

Secondary outcome:

Sleep Questionnaire Form A

Quality of Life for RLS questionnaire

Clinical Global Impressions

Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography

Total score of the severity rating scale of the International RLS (IRLS) Study Group

RLS-6 severity scales


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Additional Information

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

Starting date: November 2002
Last updated: April 22, 2011

Page last updated: August 23, 2015

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