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Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome

NCT00152997 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-10-31

No results posted yet for this study

Summary

The objective of this trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International Restless Legs Syndrome Study Group (IRLSSG) as a sub-study.

Conditions

  • Restless Legs Syndrome

Interventions

DRUG

Pramipexole 0.125 mg tablets

DRUG

Pramipexole 0.125 mg tablets Placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim Study Coordinator · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-12-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152997 on ClinicalTrials.gov