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

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

Condition(s) targeted: Restless Legs Syndrome

Intervention: Pramipexole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: B.I. Pharmaceuticals,Inc./Ridgefield

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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)

CGI-I (CGI-Improvement)

Secondary outcome:

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

CGI-I responder analysis

Change from baseline in CGI-Severity

CGI-therapeutic effect

CGI-Side effects

Patient Global Impression (PGI)

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

Change from baseline in Epworth sleepiness scale (ESS)

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

Change from baseline in Augmentation Severity Rating Scale of IRLSSG

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

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

Change in routine laboratory tests

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

Change in Electrocardiogram

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

Concomitant medication reporting

Early withdrawal phenomena

Assessment of sudden onset of sleep (SOOS)

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Locations and Contacts

Pivotal Research Centers, Peoria, Arizona 85381, United States

Mayo Clinic - Scottsdale, Scottsdale, Arizona 85259, United States

Boehringer Ingelheim Investigational Site, Fountain Valley, California 92708, United States

HealthQuest Clinical Trials Research, San Diego, California 92123, United States

Stanford Sleep Clinic, Stanford, California 94305-5730, United States

Adult CF Center, Denver, Colorado 80206, United States

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

CNI Movement Disorders Center, Englewood, Colorado 80113, United States

George Washington University Medical Faculty Associates, Washington, District of Columbia 20037, United States

PAB Clinical Research, Brandon, Florida 33511, United States

Broward Research Group, Pembroke Pines, Florida 33026-1956, United States

Clinical Research Group of St Petersburg, St.Petersburg, Florida 33707, United States

Cleveland Clinic Florida- Department of Neurology, Weston, Florida 33331, United States

5671 Peachtree Dunwoody Road, Atlanta, Georgia 30342, United States

Atlanta Pulmonary Group, LLC, Atlanta, Georgia 30342, United States

Movement Disorders Clinic, Augusta, Georgia 30912, United States

Sleepmed, Inc, Macon, Georgia 31201, United States

University of Iowa Health Care, Iowa City, Iowa 52242-1053, United States

Mid America NeuroScience Institute, Lenexa, Kansas 66214, United States

Boehringer Ingelheim Investigational Site, Baton Rouge, Louisiana 70808, United States

Center for Sleep and Wake Disorders, Chevy Chase, Maryland 20815, United States

170 Thomas Johnson Dr, Suite 100, Frederick, Maryland 21702, United States

Sleep Health Centers, Newton Center, Massachusetts 02459, United States

Henry Ford Hospital - Sleep Disorders and Research Center, Detroit, Michigan 48202, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

Sleep Disorders Center, Jackson, Mississippi 39216, United States

Sleep Medicine Center, St.Louis, Missouri 63108, United States

Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States

Winthrop Sleep Disorders Center, Mineola, New York 11501, United States

932 Morreene Road #264, Durham, North Carolina 27705, United States

Raleigh Neurology Associates, Raleigh, North Carolina 27607, United States

Wilmington Health Associates, Wilmington, North Carolina 28401, United States

Attn: Dr. David Mayleben, Cincinnati, Ohio 45219, United States

Metrohealth Medical Center, Cleveland, Ohio 44109, United States

Ohio Sleep Medicine Institute, Dublin, Ohio 43017, United States

Attn: Controller/Grants & Contracts Accounting, Oklahoma City, Oklahoma 73190-3046, United States

Center For Sleep Medicine, Lafayette Hill, Pennsylvania 19444, United States

The Arthritis Group, Philadelphia, Pennsylvania 19152, United States

Boehringer Ingelheim Investigational Site, Columbia, South Carolina 29201, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Sleep Associates, Plano, Texas 75093, United States

1500 N. Bearegard St, #300, Alexandria, Virginia 22311, United States

Lynchburg Pulmonary Associates, Inc., Lynchburg, Virginia 24501, United States

Eastern Virginia Medical School, Norfolk, Virginia 23507, United States

Additional Information

Starting date: April 2004
Last updated: November 7, 2013

Page last updated: August 23, 2015

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