NCT04462770 (ARGUS) is a Phase 3 clinical trial of Clemizole HCl in Dravet Syndrome, sponsored by Epygenix.

Who is sponsoring NCT04462770?

NCT04462770 is sponsored by Epygenix.

What drugs are being tested in NCT04462770?

Interventions in NCT04462770: Clemizole HCl, Placebo.

What condition does NCT04462770 study?

NCT04462770 studies Dravet Syndrome.

Is NCT04462770 still recruiting?

NCT04462770 is currently recruiting now. Last updated 28 August 2025.

Last reviewed 2025-08-28 · How we verify

NCT04462770: ARGUS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 28 August 2025

What this trial tests

Phase 3 trial testing Clemizole HCl in Dravet Syndrome in 150 participants. Currently enrolling.

Timeline

15 September 2020

Primary endpoint
1 April 2026

1 May 2029

Quick facts

Lead sponsor	Epygenix
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	150
Start date	15 September 2020
Primary completion	1 April 2026
Estimated completion	1 May 2029
Sites	46 locations across Georgia, United Kingdom, Poland, Hungary, Romania, Canada, United States, Spain

Drugs / interventions tested

Clemizole HCl — full drug profile →
Placebo

Conditions studied

Dravet Syndrome — all drugs for Dravet Syndrome →

Sponsor

Epygenix — full company profile →

Who can join

2 and older, any sex, with Dravet Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Zebrafish disease models in drug discovery: from preclinical modelling to clinical trials.
Patton EE, Zon LI, Langenau DM. · · 2021 · cited 379× · PMID 34117457 · DOI 10.1038/s41573-021-00210-8
Phenotypic analysis of catastrophic childhood epilepsy genes.
Griffin A, Carpenter C, Liu J, Paterno R, et al · · 2021 · cited 61× · PMID 34083748 · DOI 10.1038/s42003-021-02221-y
A zebrafish-centric approach to antiepileptic drug development.
Baraban SC. · · 2021 · cited 31× · PMID 34231838 · DOI 10.1242/dmm.049080
Pharmacotherapy for Dravet Syndrome: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.
Lattanzi S, Trinka E, Russo E, Del Giovane C, et al · · 2023 · cited 28× · PMID 37695433 · DOI 10.1007/s40265-023-01936-y
Zebrafish, an In Vivo Platform to Screen Drugs and Proteins for Biomedical Use.
Lee HC, Lin CY, Tsai HJ. · · 2021 · cited 26× · PMID 34073947 · DOI 10.3390/ph14060500
Enhancing glucose metabolism via gluconeogenesis is therapeutic in a zebrafish model of Dravet syndrome.
Banerji R, Huynh C, Figueroa F, Dinday MT, et al · · 2021 · cited 24× · PMID 33842883 · DOI 10.1093/braincomms/fcab004
Pharmacological diversity amongst approved and emerging antiseizure medications for the treatment of developmental and epileptic encephalopathies.
Sills GJ. · · 2023 · cited 19× · PMID 37655228 · DOI 10.1177/17562864231191000
Diving into the zebrafish brain: exploring neuroscience frontiers with genetic tools, imaging techniques, and behavioral insights.
Doszyn O, Dulski T, Zmorzynska J. · · 2024 · cited 18× · PMID 38533456 · DOI 10.3389/fnmol.2024.1358844

Verify or expand the search:

Other trials of Clemizole HCl

Trials testing the same drug.

NCT05066217 — An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome · Phase 3 · recruiting

Other recruiting trials for Dravet Syndrome

Currently open trials in the same condition.

NCT07251673 — Longitudinal Study of Phenotypic and Developmental Severity in Patients With Dravet Syndrome With SCN1A Gene Mutation · recruiting
NCT06401538 — BMB-101 in Absence Epilepsy and DEE · Phase 2 · recruiting
NCT06660394 — A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS) · Phase 3 · recruiting
NCT06118255 — A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less · Phase 3 · active not recruiting
NCT06504511 — SCN1A Horizons A Natural History Study of SCN1A-related Epilepsies in the United Kingdom · recruiting

Other Epygenix trials

Trials by the same sponsor.

NCT05066217 — An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome · Phase 3 · recruiting
NCT04069689 — Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects. · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04462770 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Epygenix
Last refreshed: 28 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04462770.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing