At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 154 enrolled
Drug / intervention
Pramipexole 0.125 mg tablet +1 moredrug
Likely dose
Pramipexole 0.125 mg tabletfrom 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 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
In Brief
A Phase 3 clinical trial evaluating Pramipexole 0.125 mg tablet and Pramipexole 0.5 mg tablet for Idiopathic Restless Legs Syndrome. Completed, enrolled 154 participants across 34 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Restless Legs Syndrome
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedOct 2006
Primary CompletionMar 2008
TodayJul 2026
First PostedOct 20, 2006
Enrollment StartOct 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.7 years ago
Interventions
Pramipexole 0.125 mg tabletdrug
Pramipexole 0.5 mg tabletdrug