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 ago nist, 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 e ffects and limited efficacy reduce clinical utility. Prior open-label repor ts of pergolide suggest potential benefit. Methods: The authors enrolled 24 children age 7 to 17 years with Tourette's disorder, chronic motor tic dis order, or chronic vocal tic disorder by Diagnostic and Statistical Manual o f Mental Disorders (4th ed.) criteria, plus severity criteria on the Yale G lobal Tic Severity Scale (YGTSS) of greater than or equal to 20, in a doubl e-blind, placebo-controlled, crossover study. Children were randomized to r eceive 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 t he alternate treatment. The primacy outcome measure was tic severity assess ed 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 random ized, placebo-controlled, crossover trial, pergolide appeared to be a safe and efficacious treatment for Tourette's syndrome in children.