Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: Pramipexole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00133198

248.543

Details and patient eligibility

About

A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.

Enrollment: 345 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind