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

NCT00133198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2013-11-08

No results posted yet for this study

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.

Conditions

Restless Legs Syndrome

Interventions

DRUG: Pramipexole

Sponsors & Collaborators

Boehringer Ingelheim
lead INDUSTRY

Principal Investigators

Boehringer Ingelheim Study Coordinator · B.I. Pharmaceuticals,Inc./Ridgefield

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: DOUBLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 80 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2004-04-30
Primary Completion: 2005-02-28
Completion: 2005-02-28

Countries

United States

Study Locations

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Companies

Boehringer Ingelheim

Summary

Conditions

Interventions

Sponsors & Collaborators

Principal Investigators

Study Design

Eligibility

Timeline & Regulatory

Countries

Study Locations

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A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS

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A Phase IV Trial With Pramipexole to Investigate the Effects on RLS Symptoms and Sleep Disturbance in Patients With RLS

Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)

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