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

NCT ID: NCT00133198

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-02-28

Brief Summary

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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

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Conditions

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Restless Legs Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pramipexole

Intervention Type DRUG

Eligibility Criteria

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Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Pharmaceuticals,Inc./Ridgefield

Locations

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Pivotal Research Centers

Peoria, Arizona, United States

Site Status

Mayo Clinic - Scottsdale

Scottsdale, Arizona, United States

Site Status

Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Site Status

HealthQuest Clinical Trials Research

San Diego, California, United States

Site Status

Stanford Sleep Clinic

Stanford, California, United States

Site Status

Adult CF Center

Denver, Colorado, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

CNI Movement Disorders Center

Englewood, Colorado, United States

Site Status

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Site Status

PAB Clinical Research

Brandon, Florida, United States

Site Status

Broward Research Group

Pembroke Pines, Florida, United States

Site Status

Clinical Research Group of St Petersburg

St. Petersburg, Florida, United States

Site Status

Cleveland Clinic Florida- Department of Neurology

Weston, Florida, United States

Site Status

5671 Peachtree Dunwoody Road

Atlanta, Georgia, United States

Site Status

Atlanta Pulmonary Group, LLC

Atlanta, Georgia, United States

Site Status

Movement Disorders Clinic

Augusta, Georgia, United States

Site Status

Sleepmed, Inc

Macon, Georgia, United States

Site Status

University of Iowa Health Care

Iowa City, Iowa, United States

Site Status

Mid America NeuroScience Institute

Lenexa, Kansas, United States

Site Status

Boehringer Ingelheim Investigational Site

Baton Rouge, Louisiana, United States

Site Status

Center for Sleep and Wake Disorders

Chevy Chase, Maryland, United States

Site Status

170 Thomas Johnson Dr, Suite 100

Frederick, Maryland, United States

Site Status

Sleep Health Centers

Newton Center, Massachusetts, United States

Site Status

Henry Ford Hospital - Sleep Disorders and Research Center

Detroit, Michigan, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Sleep Disorders Center

Jackson, Mississippi, United States

Site Status

Sleep Medicine Center

St Louis, Missouri, United States

Site Status

Lovelace Scientific Resources

Albuquerque, New Mexico, United States

Site Status

Winthrop Sleep Disorders Center

Mineola, New York, United States

Site Status

932 Morreene Road #264

Durham, North Carolina, United States

Site Status

Raleigh Neurology Associates

Raleigh, North Carolina, United States

Site Status

Wilmington Health Associates

Wilmington, North Carolina, United States

Site Status

Attn: Dr. David Mayleben

Cincinnati, Ohio, United States

Site Status

Metrohealth Medical Center

Cleveland, Ohio, United States

Site Status

Ohio Sleep Medicine Institute

Dublin, Ohio, United States

Site Status

Attn: Controller/Grants & Contracts Accounting

Oklahoma City, Oklahoma, United States

Site Status

Center For Sleep Medicine

Lafayette Hill, Pennsylvania, United States

Site Status

The Arthritis Group

Philadelphia, Pennsylvania, United States

Site Status

Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Sleep Associates

Plano, Texas, United States

Site Status

1500 N. Bearegard St, #300

Alexandria, Virginia, United States

Site Status

Lynchburg Pulmonary Associates, Inc.

Lynchburg, Virginia, United States

Site Status

Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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248.543

Identifier Type: -

Identifier Source: org_study_id