At a glance
ClinicalIndex Comparison RecordN/ACompleted· 549 enrolled
Drug / intervention
Sifrol® (pramipexole dihydrochloride)drug
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.
Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS
In Brief
An observational study evaluating Sifrol® (pramipexole dihydrochloride) for Restless Legs Syndrome. Completed, enrolled 549 participants across 127 sites.
Detailed Summary
The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
CountriesAustria
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedJul 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedJul 24, 2008
Enrollment StartSep 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.9 years ago
Interventions
Sifrol® (pramipexole dihydrochloride)drug