Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Pramipexole

• Registration Number: NCT02248142
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-22
• Last Update Submitted: 2014-09-22
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1029

Inclusion Criteria

• Patients suffering from primary RLS who are planned to be initiated on treatment with pramipexole as part of the routine care could be included into the study
• Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pretreated with dopaminergic medication
• Male or female patients of any age

Exclusion Criteria

• Treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SPC) for the treatment with pramipexole

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RLS patients	Pramipexole	-

Primary Outcome Measures

Name	Time	Method
Assessment of RLS symptoms (IRLS) on a 4-point rating scale	up to 12 weeks
Assessment of RLS severity on a 6-point rating scale	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale	up to 12 weeks
Number of patients with adverse events	up to 12 weeks
Time to reach maintenance dose of pramipexole	up to 12 weeks
Global assessment of efficacy by investigator on a 5-point scale	after 12 weeks