Teva Pharmaceutical Industries Ltd. announced deutetrabenazine failed to meet the endpoint in in Phase II/III trials to treat tics in pediatric patients with Tourette Syndrome.
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Published:22nd Feb 2020
Teva Pharmaceutical Industries Ltd. announced the Phase II/III ARTISTS 1 and Phase III ARTISTS 2 trials designed to evaluate deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary endpoint of reduction in motor and phonic tics as assessed by the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS). In the data received this week, the most commonly reported adverse event in the ARTISTS 1 and ARTISTS 2 studies were headache, somnolence and fatigue. In this population, no new safety signals were identified that were inconsistent with the known safety profile of deutetrabenazine.
Condition: Tourette Syndrome