January 30, 2017
Psyadon Pharmaceuticals released results of a phase IIb study of ecopipam for treatment of total tic severity scores in children (7-17 years) with Tourette’s syndrome. The study was a double-blind, randomized, placebo-controlled crossover study. Patients were instructed to take the study medication (either ecopipam or placebo) each evening before bedtime over a four-week treatment period. Patients were evaluated in the clinic every other week with telephone contacts on the alternate weeks. The primary efficacy endpoint was the change in the Yale Global Tic Severity Score–Total Tic Score (YGTSS-TTS), a well-validated rating scale typically used in Tourette’s syndrome trials. The study was fully enrolled at 40 subjects. The study’s primary endpoint was a statistically significant reduction in the mean Yale Global Tic Severity Score Total Tic Score (YGTSS-TTS). This is a well-validated and standard measure of the clinical efficacy of drugs treating Tourette’s syndrome. Ecopipam caused significant reductions in the YGTSS-TTS at both two- and four weeks after initiating treatment. Furthermore, the side effects seen in the subjects taking ecopipam were comparable to those seen in the placebo-treated subjects, including no clinically significant changes in standard clinical lab tests or ECGs, and no increases in body weights.
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.