Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks

This study has been completed.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00133198

Purpose

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

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: Pramipexole	Phase III

MedlinePlus related topics: Restless Legs

Drug Information available for: Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

restless legs syndrome

Estimated Enrollment:	344
Study Start Date:	April 2004
Estimated Study Completion Date:	February 2005

Detailed Description:

Study Hypothesis:

Comparison(s):

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133198

Show 44 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. Pharmaceuticals,Inc./Ridgefield

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	248.543
Study First Received:	August 22, 2005
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00133198
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Ekbom syndrome
Sleep Disorders
Dyssomnias
Psychomotor Agitation
Dyskinesias
Pramipexol
Sleep Disorders, Intrinsic

Signs and Symptoms
Dopamine
Mental Disorders
Restless Legs Syndrome
Neurologic Manifestations
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Parasomnias
Physiological Effects of Drugs
Antiparkinson Agents

Dopamine Agonists
Protective Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Syndrome
Psychomotor Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009