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July 30, 2012
Psyadon Pharmaceuticals issued results from a phase II trial of ecopipam for the treatment of Tourette’s syndrome. This eight-week, multi-center, open-label, non-randomized study enrolled 15 patients with moderate to severe Tourette’s syndrome. Subjects received ecopipam 50mg/day for the first two weeks and then 100mg/day for the remaining six weeks. The results showed a statistically significant (p<0.001) reduction in the total tic severity scores of the Yale Global Tic Severity Score, a well-validated rating scale typically used in Tourette’s trials. This effect was seen in the analysis of both patients who completed all visits (completer analysis; n=12) and all enrolled patients (intent-to-treat analysis; n=15). The study was stopped early when a planned interim analysis revealed a statistically significant reduction in the severity of the patients’ tic symptoms. Ecopipam was well tolerated. The most frequent adverse events were fatigue, nausea, sedation, headache, restlessness and sleeplessness. Psyadon is eager to move ecopipam into phase III trials.