Trial Profile

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)

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 09 Sep 2026

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At a glance

03 Sep 2026 According to a Harmony Biosciences media release, company will present data from EPX-100 (clemizole hydrochloride) from this trial, at the 16th European Epilepsy Congress being held from Sep 5-9, in Athens, Greece.
04 Aug 2026 According to a Harmony Biosciences media release, PDUFA dates anticipated in 2028.
14 May 2026 Planned primary completion date changed from 1 Apr 2026 to 1 Apr 2027.

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