NCT00390689

A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.

A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.

Conditions

• Idiopathic Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Pramipexole 0.125 mg tablet
DRUG	Pramipexole 0.5 mg tablet

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-03-01
• First posted: 2006-10-20
• Last updated: 2014-07-02
• Results posted: 2009-08-25

Locations

34 sites across 1 country: Japan