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

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

—

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Pramipexole; p = 0.996; Least Squares mean difference 0.01 (95% CI -4.95 to 4.97); ANCOVA NCT00558467 ↗

Drugs

Indications