A multicenter randomized placebo-controlled clinical trial of pramipexole for Tourette's syndrome.

Background: Dopamine agonists could theoretically normalize the suspected central dopamine hypersensitivity in Tourette's syndrome.

Methods: There was a multicenter randomized, placebo-controlled, double-blind clinical trial of pramipexole given for 6 weeks in 63 children and adolescents with Tourette's syndrome.

Results: There were no significant differences in the adjusted mean change in the Total Tic Score of the Yale Global Tic Severity Scale for patients treated with pramipexole (-7.16) and placebo (-7.17). There were no significant treatment effects on change from baseline in the Global Severity score of the Yale Scale and parent- and investigator-scored Clinical Global Impression of Improvement. In patients with attention deficit hyperactivity disorder, there was improvement in DuPaul ADHD scale scores for patients receiving pramipexole compared with placebo.

Conclusions: There was no evidence that pramipexole has efficacy in suppressing tics. Pramipexole may decrease symptoms of associated attention deficit hyperactivity disorder.