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

Boehringer Ingelheim1,029 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

1,029

Conditions

Restless Legs Syndrome

Interventions

PramipexoleDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Assessment of RLS symptoms (IRLS) on a 4-point rating scale

Time frame: up to 12 weeks

Assessment of RLS severity on a 6-point rating scale

Time frame: up to 12 weeks

Secondary Outcomes

Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale

Time frame: up to 12 weeks

Global assessment of efficacy by investigator on a 5-point scale

Time frame: after 12 weeks

Number of patients with adverse events

Time frame: up to 12 weeks

Time to reach maintenance dose of pramipexole

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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