NCT05066217

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Epygenix · Industry
• Sex: All
• Age: 2 Years – 55 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 HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).

Detailed description

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCl as adjunctive therapy in children and adult participants with LGS. The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.

Conditions

• Lennox Gastaut 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: 2025-04-09
• Primary completion: 2026-11-01
• Completion: 2029-11-01
• First posted: 2021-10-04
• Last updated: 2026-04-15

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study