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Completed

NCT Number: NCT00133198

Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pivotal Research Centers, Peoria, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Treatment and study plan

Pramipexole

Drug

Primary outcomes

  1. Change from baseline in the total score of RLSRS (Restless Legs Syndrome rating scale for severity) of the IRLSSG (International Restless Legs Syndrome Study Group)

    Time frame: week 12

  2. CGI-I (CGI-Improvement)

    Time frame: week 12

Secondary outcomes

  1. RLSRS response (≥50% reduction from baseline in RLSRS)

    Time frame: at week 4, 6 and 12

  2. CGI-I responder analysis

    Time frame: at week 4, 6 and 12

  3. Change from baseline in CGI-Severity

    Time frame: at week 4, 6 and 12

  4. CGI-therapeutic effect

    Time frame: at week 4, 6 and 12

  5. CGI-Side effects

    Time frame: at week 4, 6 and 12

  6. Patient Global Impression (PGI)

    Time frame: at week 1-4, 6 and 12

  7. Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep

    Time frame: at week 4, 6 and 12

  8. Change from baseline in Epworth sleepiness scale (ESS)

    Time frame: at week 4, 6 and 12

  9. Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire)

    Time frame: at week 6 and 12

  10. Change from baseline in Augmentation Severity Rating Scale of IRLSSG

    Time frame: at week 6 and 12

  11. Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing)

    Time frame: week 12

  12. Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing)

    Time frame: week 12

  13. Change in routine laboratory tests

    Time frame: week 12

  14. Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination

    Time frame: week 12

  15. Change in Electrocardiogram

    Time frame: 12 weeks

  16. Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms)

    Time frame: up to 93 days

  17. Concomitant medication reporting

    Time frame: 12 weeks

  18. Early withdrawal phenomena

    Time frame: 12 weeks

  19. Assessment of sudden onset of sleep (SOOS)

    Time frame: up to 93 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Aug 23, 2005
Registry last updated
Nov 8, 2013

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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