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

Name: An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome — clinical trial record (NCT05066217)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorEpygenix

Started2025-04-09

View on ClinicalTrials.gov ↗

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).

Amendment history 3 changes detected by DataLookout

2026-09-16

Trial sites expanded: 55 → 58 locations

2026-08-22

Trial sites expanded: 26 → 55 locations

2026-07-03

Trial sites expanded: 20 → 26 locations

Trial Details

NCT Number	NCT05066217
Lead Sponsor	Epygenix Collaborators: Harmony Biosciences Management, Inc.
Conditions	Lennox Gastaut Syndrome
Enrollment	260 participants
Start Date	2025-04-09
Primary Completion	2026-11-01 (estimated)
Study Completion	2029-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-09-15