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

NCT04462770 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-14

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 hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

Conditions

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2027-04-30
Completion
2029-05-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Georgia
  • Hungary
  • India
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04462770 on ClinicalTrials.gov