Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients

Phase 3

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00275457
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.

Detailed Description

To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension

Study Hypotheses:

Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment.

Comparison(s):

Pramipexole vs. Placebo

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to week 6 on the RLSRS +
CGI-I responders (much and very much improved)

Secondary Outcome Measures

Name	Time	Method
RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS

Trial Locations

Locations (14)

Univ.-Klinik für Neurologie; 🇦🇹 Innsbruck, Austria

Boehringer Ingelheim Investigational Site; 🇸🇪 Örebro, Sweden

Confraternität Privatklinik; 🇦🇹 Wien, Austria

AKH der Stadt Linz; 🇦🇹 Linz, Austria

Sonderkrankenanstalt für neurologischen und; 🇦🇹 Wien, Austria

AKH Universitätsklinik für Psychiatrie; 🇦🇹 Wien, Austria

Wilhelminenspital der Stadt Wien; 🇦🇹 Wien, Austria

Facharzt für Neurologie; 🇩🇪 Emmendingen, Germany

emovis GmbH; 🇩🇪 Berlin, Germany

ClinPharm International GmbH & Co. KG; 🇩🇪 Leipzig, Germany

Universitätsklinikum Giessen und Marburg; 🇩🇪 Marburg, Germany

Neurologkliniken; 🇸🇪 Stockholm, Sweden

Stockholms Neuro Center; 🇸🇪 Stockholm, Sweden

Läkarhuset Vällingby; 🇸🇪 Vällingby, Sweden