drugset / Trial / NCT00558467

Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

NCT00558467

Phase 2 Completed 63 enrolled Boehringer Ingelheim
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-01
Primary completion
2009-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Pramipexole Unknown 0.125 mg
Subject Pramipexole Unknown 0.5 mg

Indications