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Title: Pergolide Appears Safe and Effective in Patients with Tourette's Syndrome: Presented at ANA

"Pergolide Appears Safe and Effective in Patients with Tourette's Syndrome: Presented at ANA"

By Thomas S. May Special to DG News NEW YORK, NY -- October 16, 2002 -- Pergolide, a mixed C1/D2/D3 dopamine agonist, appears to be safe and effective in the treatment of children and adolescents with Tourette's syndrome, new research suggests. Dr. Donald Gilbert, director of the Tourette's Syndrome and Movement Disorders Clinics in Cincinnati, Ohio, United States, presented the findings here October 15 at the 127th annual meeting of the American Neurological Association (ANA). Neuroleptics, which block dopamine transmission, are currently used for the treatment of children with severe tics, but major side effects and limited efficacy reduce their clinical utility. Results of prior open-label and crossover studies of pergolide have indicated that it may suppress tics. In an attempt to investigate this possibility, Dr. Gilbert and colleagues enrolled 56 children, aged 7 to 17 years, who had been diagnosed with Tourette's syndrome, in a randomised, double-blind, placebo-controlled trial. Patients were given 0.15-0.45 mg pergolide daily or placebo during the eight-week study. Tic severity was assessed by the Yale Global Tic Severity Scale (YGTSS). Compared with placebo treatment, pergolide treatment was associated with significantly greater tic reduction (pergolide vs. placebo treatment effect = 8.8 units; p=0.05). No serious adverse events occurred in any of the patients, and pergolide was well tolerated. "This trial is the largest study of dopamine agonists for tic reduction, and the results show a statistically significant, mild to moderate tic reduction, as well as significant improvement in attention deficit hyperactive disorder symptoms," Dr. Gilbert said. "The greatest benefit tended to occur in the younger children," he added. Medications currently used for tic suppression tend to have modest benefit, and in some cases, undesirable side effects, according to Dr. Gilbert. "If clonidine and guanfacine are not effective, pergolide may be a reasonable choice prior to trying a neuroleptic medication," he suggested. The study was funded by a grant from the United States' Food and Drug Administration (FDA).

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