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

Boehringer Ingelheim

Status: Completed

Conditions: Restless Legs Syndrome

Treatments: Drug: Pramipexole

Study type: Observational

Funder types: Industry

Identifiers

NCT02248142

248.623

Details and patient eligibility

About

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)

Enrollment: 1,029 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,029 participants in 1 patient group

RLS patients

Treatment:

Drug: Pramipexole