At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
MIRAPEX® - low +2 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.
An Open-label Clinical Study to Investigate Pharmacokinetics (PK) of Different Doses (0.125 mg, 0.25 mg, 0.5 mg) of Pramipexole Administered Once Daily Orally in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
In Brief
A Phase 2 clinical trial evaluating MIRAPEX® - low, MIRAPEX® - medium, and 1 other intervention for Restless Legs Syndrome. Completed, enrolled 26 participants.
Detailed Summary
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
Primary CompletionJul 2007
First PostedSep 2014
TodayJul 2026
First PostedSep 4, 2014
Enrollment StartMay 1, 2006
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.8 years ago
Interventions
MIRAPEX® - lowdrug
MIRAPEX® - mediumdrug
MIRAPEX® - highdrug