Estudio sobre Ecopipam
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.
Detalles del Estudio
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.
During the open-label and double-blind phases, the most common side effects of ecopipam were somnolence (11.1%), anxiety (9.7%), headache (9.7%), insomnia (8.8%), tics (7.9%), and fatigue (6.5%). Suicidal ideation adverse events were reported in five participants (2.3%) during the open-label period and one participant (1.9%) in the placebo group during the randomized withdrawal period, the researchers said.
The drug did not have a clinically meaningful effect on weight, metabolic parameters, or psychiatric scale measures and did not appear to induce movement disorders, Gilbert and colleagues observed.
Fuente: https://www.medpagetoday.com/neurology/generalneurology/121426
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