Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

Summary

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

Timeline

Start

2008-04

Primary completion

2009-06

Completion

2009-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Pramipexole vs Placebo; p <0.0001; Mean Difference (Final Values) -4.52 (95% CI -6.58 to -2.46); ANCOVA NCT00654498 ↗

registry analysis (superiority or other test); Pramipexole vs Placebo; p <0.0001; Cochran-Mantel-Haenszel NCT00654498 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pramipexole	Unknown	0.125 mg	Oral
Subject	Pramipexole	Unknown	0.25 mg	Oral
Subject	Pramipexole	Unknown	0.5 mg	Oral
Subject	Pramipexole	Unknown	0.75 mg	Oral

Indications