Tourette's syndrome improvement with pergolide in a randomized, double-blind, crossover trial

Objective: To determine whether pergolide, a mixed D-1-D-2-D-3 dopamine agonist, is efficacious and safe in the treatment of children with Tourette's syndrome. Background: Neuroleptics, which block dopamine transmission, are currently used for treatment of children with severe ties, but major side effects and limited efficacy reduce clinical utility. Prior open-label reports of pergolide suggest potential benefit. Methods: The authors enrolled 24 children age 7 to 17 years with Tourette's disorder, chronic motor tic disorder, or chronic vocal tic disorder by Diagnostic and Statistical Manual of Mental Disorders (4th ed.) criteria, plus severity criteria on the Yale Global Tic Severity Scale (YGTSS) of greater than or equal to 20, in a double-blind, placebo-controlled, crossover study. Children were randomized to receive either placebo or up to 300 mu g/day pergolide for the first 6-week treatment period, with a a-week placebo washout, followed by crossover to the alternate treatment. The primacy outcome measure was tic severity assessed by YGTSS. Results: Compared with placebo treatment, pergolide treatment was associated with significantly lower YGTSS scores (42.0 +/- 20.4 versus 23.5 +/- 18.7; F = 12.0, df = 1, 17, p = 0.0011). No patient had a serious adverse event and pergolide was well tolerated. Conclusions: In this randomized, placebo-controlled, crossover trial, pergolide appeared to be a safe and efficacious treatment for Tourette's syndrome in children.