October 30, 2017

D1 Antagonist Ecopipam Effective for Children, Adolescents With Tourette’s Disorder

By Andrew D. Bowser

WASHINGTON, DC -- October 30, 2017 -- Ecopipam, a D1 receptor antagonist, was effective and well-tolerated as a treatment for children and adolescents with Tourette’s disorder, according to a study presented here at the 2017 Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP).

“The ability to have diminution of their ticks without all the onerous side effects that our current treatments are associated with is a real advantage, particularly in this population of children with Tourette’s disorder,” said Cathy L. Budman, MD, North Shore University, Manhasset, New York.

The study included 40 children and teens aged 7 to 17 years who had a total tic score of at least 20 on the Yale Global Tic Severity Scale (YGTSS). Patients were randomised to ecopipam or placebo for 4 weeks, followed by a 2-week washout period, and then a crossover to the other treatment for an additional 4 weeks.

Ecopipam was dosed at 50 mg/day orally for patients weighing less than 34 kg and 100 mg/day for heavier subjects (>43 kg).

Total YGTSS score -- the primary endpoint -- was significantly improved in the ecopipam arm (-5.6 vs -3.4, respectively; P = .043).

There were also improvements in the ecopipam arm in the Clinical Global Impression of Improvement (CGI-I) scale (-0.78 for ecopipam vs -0.21 for placebo; P < .01).

There were no differences between groups in ADHD-Rating Scale total scores, investigators said.

Side effects were “only marginally greater than placebo,” with 4 adverse events rated as severe. The most common adverse events were mild sedation, gastrointestinal symptoms, and headache, with no changes in body weight or ECG noted.

“When we've spoken to patients, what we find is patients are switching drugs all the time because they're trying to find a balance between efficacy and side effects,” noted Richard E. Chipkin, PhD, Psyadon Pharmaceuticals, Inc., Germantown, Maryland. “We think that because of the mild nature of the side effects associated with this drug, they won't be switching around as much, and they'll be able to stay on their drugs and get efficacy.”

Funding for this study was provided by Psyadon Pharmaceuticals, Inc.

[Presentation title: A Randomized, Double-Blind, Placebo-Controlled Study of the D1 Receptor Antagonist Ecopipam for Children and Adolescents With Tourette's Disorder. Abstract 4.36]

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