At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 404 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Ropinirole 0.25mgfrom 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 Parallel Group Study to Evaluate the Efficacy and Safety of Ropinirole for 26 Weeks and to Further Evaluate the Incidence of Augmentation and Rebound for a Further 40 Weeks Open-label Extension Treatment Period in Subjects Suffering From Moderate to Severe Restless Legs Syndrome.
In Brief
A Phase 4 clinical trial evaluating Placebo and Ropinirole for Restless Legs Syndrome. Completed, enrolled 404 participants across 39 sites in 11 countries.
Detailed Summary
This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesAustralia, Czechia, Denmark, Germany, Italy, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMay 2006
Primary CompletionSep 2008
TodayJul 2026
First PostedMay 25, 2006
Enrollment StartMar 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.1 years ago
Interventions
Placebodrug
Matching Placebo
Ropiniroledrug
Ropinirole IR 0.25mg/day to 4mg/day for RLS