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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pramipexole

Criteria

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