NCT04462770

A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

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: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Epygenix · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

Detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of clemizole hydrochloride as adjunctive therapy in children and adult participants with DS. The study consists of a 4-week Observational Period, a 16-week Double-Blind (DB) Period and an Open-Label Extension (OLE) Period for up to 156 weeks.

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
DRUG	Clemizole HCl	Clemizole HCl will be administered as an oral solution.
DRUG	Placebo	Placebo will be administered as an oral solution.

Timeline

• Start date: 2020-09-15
• Primary completion: 2026-04-01
• Completion: 2029-05-01
• First posted: 2020-07-08
• Last updated: 2025-08-28

Locations

46 sites across 8 countries: United States, Canada, Georgia, Hungary, Poland, Romania, Spain, United Kingdom

Regulatory

• FDA-regulated drug study