Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

Boehringer Ingelheim

Status: Completed

Conditions: Restless Legs Syndrome

Treatments: Drug: Sifrol® (pramipexole dihydrochloride)

Study type: Observational

Funder types: Industry

Identifiers

NCT00721279

248.655

Details and patient eligibility

About

The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole

Enrollment: 549 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Restless Legs Syndrome (i.e. idiopathic RLS)
• Indication for treatment with pramipexole
• Male or female patients older than 18 years

Exclusion criteria

• Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
• Current treatment with pramipexole