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Completed

NCT Number: NCT00625547

A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.

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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

Primary location

Pfizer Investigational Site, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
  • Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
  • No previous treatment for RLS or dissatisfaction with their current therapy

Exclusion criteria

  • Not available

Treatment and study plan

cabergoline

Drug

Cabergoline oral tablets: 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 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events

levodopa

Drug

Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events

Primary outcomes

  1. Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)

    Time frame: Week 6

  2. Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)

Secondary outcomes

  1. RLS quality-of-life questionnaire

    Time frame: Weeks 6 and 30

  2. Clinical Global Impression

    Time frame: Weeks 6 and 30

  3. Patient Global Impression

    Time frame: Weeks 6 and 30

  4. Sleep questionnaire form A

    Time frame: Weeks 6 and 30

  5. IRLSSG-RS

    Time frame: Week 30

  6. Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram

    Time frame: Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2

  7. Rating of severity of RLS at night (RLS-6 scale)

    Time frame: Weeks 6 and 30

  8. Rating of severity of RLS before bedtime (RLS-6 scale)

    Time frame: Weeks 6 and 30

  9. Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)

    Time frame: Weeks 6 and 30

  10. Global rating of quality of sleep (RLS-6 scale)

    Time frame: Weeks 6 and 30

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Important dates

Study start
2003
Study completion
2004
First posted
Feb 28, 2008
Registry last updated
Oct 29, 2008

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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