At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 enrolled
Drug / intervention
pramipexole immediate release (IR) +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, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.
In Brief
A Phase 2 clinical trial evaluating pramipexole immediate release (IR) and Placebo for Tourette Syndrome. Completed, enrolled 63 participants across 16 sites in 2 countries.
Detailed Summary
A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette Syndrome
CountriesGermany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2007
Enrollment StartJan 2008
Primary CompletionJun 2009
TodayJul 2026
First PostedNov 15, 2007
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.6 years ago
Interventions
pramipexole immediate release (IR)drug
Placebodrug