A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants with Dravet Syndrome (ARGUS Trial)
EPX-100
What is the goal of the study?
This is a 20-Week Multicenter, randomized, double-blind, placebo-controlled, dose escalation design of EPX-100 (Clemizole HCl) as adjunctive therapy in Patients with Dravet Syndrome (ARGUS trial). The study will contain the following phases: Observational Phase (period): This is approximately 4 weeks. Dose Titration Phase: All qualifying participants who meet all inclusion and exclusion criteria will enter the study and be randomized 1:1 to EPX-100 or placebo. This phase will occur over 4 weeks. Maintenance Phase: This phase will last 12 weeks. Open Label Extension Phase: All participants have the option to go on to the 52-week Open Label Extension (OLE) Phase. The primary endpoint is to evaluate the effectiveness of oral EPX-100 in divided doses as adjunctive therapy compared with placebo in participants with Dravet Syndrome. This will be evaluated in terms of the mean percent change in countable convulsive seizure frequency in the Titration and Maintenance periods relative to baseline. About 74 total participants ages 2 and older will be enrolled in all sites.
Who can participate in the study?
Please contact the study team listed below to learn more.