Deutetrabenazine Fails Trials for Children with Tourette’s Syndrome

In February Teva Pharmaceutical Industries Ltd. announced that Austedo (deutetrabenazine) did not meet the primary endpoints of trials comparing the drug to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette’s Syndrome. Austedo is currently approved for the treatment of chorea associated with Huntington’s disease and for tardive dyskinesia in adults.

The phase 2/3 ARTISTS 1 study evaluated the safety, tolerability, and efficacy of Austedo in 119 patients aged 6 to 16 years with moderate to severe Tourette’s Syndrome. Patients received either deutetrabenazine or placebo for 12 weeks. The primary endpoint was the change in the Yale Global Tic Severity Scale total tic score (YGTSS-TTS) from baseline to week 12.

In the phase 3 ARTISTS 2 study, 158 patients aged 6 to 16 years with moderate to severe Tourette’s Syndrome received either low-dose or high-dose Austedo or placebo over eight weeks. The primary endpoint was the change in YGTSS-TTS from baseline to week eight between placebo and active treatment groups. ■