Investigational ecopipam lowered relapse risk in pediatric Tourette patients compared with placebo over 24 weeks.Common side effects in the phase III trial included somnolence, anxiety, headache, and insomnia.Adult results trended similarly, but small sample size limited statistical significance.
Children and adolescents with Tourette syndrome had a lower risk of relapses with investigational ecopipam, a phase III randomized withdrawal study showed.
Compared with placebo, ecopipam reduced relapse risk in 90 pediatric participants up to 24 weeks (HR 0.47, 95% CI 0.26-0.84, P=0.008), according to Donald Gilbert, MD, MS, of Cincinnati Children's Hospital Medical Center in Ohio, and co-authors.
The effect appeared to be similar among 14 adult Tourette syndrome patients but was not significant (HR 0.51, 95% CI 0.11-2.30, P=0.37), the researchers reported in JAMA Neurology.
The study included a 12-week open-label period and a 12-week double-blind, randomized withdrawal period for participants who had clinically meaningful tic reductions.
