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

NCT05066217 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-04-15

No results posted yet for this study

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).

Conditions

  • Lennox Gastaut Syndrome

Interventions

DRUG

Clemizole HCl

Clemizole HCl will be administered as an oral solution.

DRUG

Placebo

Placebo will be administered as an oral solution.

Sponsors & Collaborators

  • Harmony Biosciences Management, Inc.

    collaborator INDUSTRY

  • Epygenix

    lead INDUSTRY

Principal Investigators

  • Amit Ray, MD · Harmony Biosciences Management, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2026-11-01
Completion
2029-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066217 on ClinicalTrials.gov