At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 306 enrolled
Drug / intervention
Pramipexole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo Controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally q.n. to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks
In Brief
A Phase 3 clinical trial evaluating Pramipexole and Placebo for Restless Legs Syndrome. Completed, enrolled 306 participants across 16 sites.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
First PostedApr 2008
Primary CompletionJun 2009
TodayJul 2026
First PostedApr 8, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.2 years ago
Interventions
Pramipexoledrug
Placebodrug