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Completed

NCT Number: NCT00627003

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

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cabergoline

Drug

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

Placebo

Other

Placebo oral tablets administered daily for 5 weeks

Primary outcomes

  1. Sleep efficiency

    Time frame: Week 5

  2. PLMS-arousal index (PLMS-AI)

    Time frame: Week 5

Secondary outcomes

  1. Sleep Questionnaire Form A

    Time frame: Weeks 2 and 5

  2. Quality of Life for RLS questionnaire

    Time frame: Weeks 2 and 5

  3. Clinical Global Impressions

    Time frame: Weeks 2 and 5

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

    Time frame: Weeks 2 and 5

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

    Time frame: Weeks 2 and 5

  6. RLS-6 severity scales

    Time frame: Weeks 2 and 5

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2003
First posted
Feb 29, 2008
Registry last updated
Apr 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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