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

Phase 3
Completed
Conditions
Restless Legs Syndrome
Registration Number
NCT00133198
Lead Sponsor
Boehringer Ingelheim
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Not specified
Target Recruitment
345
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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)week 12
CGI-I (CGI-Improvement)week 12
Secondary Outcome Measures
NameTimeMethod
CGI-I responder analysisat week 4, 6 and 12
Change from baseline in CGI-Severityat week 4, 6 and 12
CGI-therapeutic effectat week 4, 6 and 12
CGI-Side effectsat week 4, 6 and 12
Patient Global Impression (PGI)at week 1-4, 6 and 12
RLSRS response (≥50% reduction from baseline in RLSRS)at week 4, 6 and 12
Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examinationweek 12
Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleepat week 4, 6 and 12
Change from baseline in Epworth sleepiness scale (ESS)at week 4, 6 and 12
Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire)at week 6 and 12
Change from baseline in Augmentation Severity Rating Scale of IRLSSGat week 6 and 12
Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing)week 12
Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing)week 12
Assessment of sudden onset of sleep (SOOS)up to 93 days
Change in routine laboratory testsweek 12
Change in Electrocardiogram12 weeks
Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms)up to 93 days
Concomitant medication reporting12 weeks
Early withdrawal phenomena12 weeks

Trial Locations

Locations (42)

Pivotal Research Centers

🇺🇸

Peoria, Arizona, United States

Mayo Clinic - Scottsdale

🇺🇸

Scottsdale, Arizona, United States

Boehringer Ingelheim Investigational Site

🇺🇸

Columbia, South Carolina, United States

HealthQuest Clinical Trials Research

🇺🇸

San Diego, California, United States

Stanford Sleep Clinic

🇺🇸

Stanford, California, United States

Adult CF Center

🇺🇸

Denver, Colorado, United States

University of Colorado Health Sciences Center

🇺🇸

Denver, Colorado, United States

CNI Movement Disorders Center

🇺🇸

Englewood, Colorado, United States

George Washington University Medical Faculty Associates

🇺🇸

Washington, District of Columbia, United States

PAB Clinical Research

🇺🇸

Brandon, Florida, United States

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Pivotal Research Centers
🇺🇸Peoria, Arizona, United States

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