For less commonly reported adverse events, a slightly higher proportion of ecopipam-treated patients experienced depression, when compared to placebo, and several ecopipam-treated patients reported anxiety.
The most frequent adverse events (≥ 5% and higher than placebo) were headache, fatigue, somnolence, and restlessness. The key secondary endpoint, the Clinical Global Impression of Tourette Syndrome Severity (CGI-TS-S), was also statistically significant at all timepoints from Week 6 to Week 12. Statistically significant and clinically meaningful results were obtained on this primary endpoint at all timepoints, from Week 4 to Week 12. The primary efficacy endpoint was the change from Baseline to Week 12 in the Yale Global Tic Severity Score-Total Tic Score (YGTSS-TTS). Study medication was titrated to the target dose over four weeks and then maintained for an eight-week treatment period. Patients were randomized to receive either ecopipam tablets at a dose of 2 mg/kg/day or placebo tablets. The D1AMOND Study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of ecopipam in 153 children and adolescents (ages 6 to < 18) conducted at 63 sites across the U.S., Canada and Europe.
"Behind the data is a strong team of scientists, clinicians, neurologists, psychiatrists and industry experts determined to develop new treatment options for those with this disease, as well as dedicated patients and families who participated in the study." Mahableshwarkar M.D., Chief Medical Officer and Senior Vice President of Drug Development. "The robust results of our ecopipam study are very encouraging, giving us momentum to continue our important work towards a safe and effective therapy for pediatric patients living with Tourette Syndrome," said Atul R. ("Emalex"), a biopharmaceutical company founded by Paragon Biosciences to develop treatments for central nervous system movement disorders and fluency disorders, today announced positive topline results from its Phase 2b clinical study (D1AMOND Study) evaluating the efficacy and safety of ecopipam (EBS-101), an investigational, first-in-class, dopamine-1 (D1) receptor antagonist, for the treatment of pediatric patients with Tourette Syndrome. 10, 2021 /PRNewswire/ - Emalex Biosciences, Inc.
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