NCT05066217 is a Phase 3 clinical trial of Clemizole HCl in Lennox Gastaut Syndrome, sponsored by Epygenix.

Who is sponsoring NCT05066217?

NCT05066217 is sponsored by Epygenix.

What drugs are being tested in NCT05066217?

Interventions in NCT05066217: Clemizole HCl, Placebo.

What condition does NCT05066217 study?

NCT05066217 studies Lennox Gastaut Syndrome.

Is NCT05066217 still recruiting?

NCT05066217 is currently recruiting now. Last updated 15 April 2026.

Last reviewed 2026-04-15 · How we verify

NCT05066217

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

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

Recruiting now Phase 3 Last updated 15 April 2026

What this trial tests

Phase 3 trial testing Clemizole HCl in Lennox Gastaut Syndrome in 260 participants. Currently enrolling.

Timeline

9 April 2025

Primary endpoint
1 November 2026

1 November 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	260
Start date	9 April 2025
Primary completion	1 November 2026
Estimated completion	1 November 2029
Sites	20 locations across United States

Drugs / interventions tested

Clemizole HCl — full drug profile →
Placebo

Conditions studied

Lennox Gastaut Syndrome — all drugs for Lennox Gastaut Syndrome →

Sponsor

Epygenix — full company profile →

Who can join

Adults 2 to 55, any sex, with Lennox Gastaut 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 HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).

Publications & conference data

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

Clemizole and trazodone are effective antiseizure treatments in a zebrafish model of STXBP1 disorder.
Moog M, Baraban SC. · · 2022 · cited 16× · PMID 35451230 · DOI 10.1002/epi4.12604
Mobilizing a New Era in Lennox-Gastaut Syndrome Treatment and Prevention.
Warren AEL, Patel AD, Helen Cross J, Clarke DF, et al · · 2025 · cited 4× · PMID 40161505 · DOI 10.1177/15357597251321926
Employing zebrafish to understand genetic drivers of epilepsy-related comorbid behaviors.
Ononuju C, Hall K, Beatty O, Baraban SC, et al · · 2026 · PMID 42158950 · DOI 10.3389/fphar.2026.1781517

Verify or expand the search:

Other trials of Clemizole HCl

Trials testing the same drug.

NCT04462770 — A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome · Phase 3 · recruiting

Other recruiting trials for Lennox Gastaut Syndrome

Currently open trials in the same condition.

NCT06401538 — BMB-101 in Absence Epilepsy and DEE · Phase 2 · recruiting
NCT06464653 — Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome · NA · active not recruiting
NCT05339126 — RNS System LGS Feasibility Study · Phase 2 · active not recruiting
NCT05374824 — Comparative Effectiveness of Palliative Surgery Versus Additional Anti-Seizure Medications for Lennox-Gastaut Syndrome · recruiting
NCT05044819 — Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution · Phase 4 · active not recruiting

Other Epygenix trials

Trials by the same sponsor.

NCT04462770 — A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet 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 NCT05066217 (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: 15 April 2026

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/NCT05066217.

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