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

ClinicalTrials.gov ID: NCT05066217

Public ClinicalTrials.gov record NCT05066217. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 11:49 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT05066217
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Epygenix; Industry
Enrollment: 260 participants

Conditions and interventions

Conditions

Lennox Gastaut Syndrome

Interventions

Clemizole HCl Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 2 Years to 55 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 8, 2025
Primary completion: Oct 31, 2026
Completion: Oct 31, 2029
Last update posted: Aug 20, 2026

2025 – 2029

United States locations

U.S. sites: 21
U.S. states: 14
U.S. cities: 18

Facility	City	State	ZIP	Site status
Arkansas Children's Hospital	Little Rock	Arkansas	72202	Active, not recruiting
UC Irvine Medical Center	Orange	California	92868	Active, not recruiting
University of Miami Miller School of Medicine	Miami	Florida	33136	Recruiting
AdventHealth Innovation Tower	Orlando	Florida	32804	Recruiting
Rare Disease Research	Orlando	Florida	34746	Suspended
Pediatric Neurology and Epilepsy Specialists	Winter Park	Florida	32789	Active, not recruiting
Re:Cognition Health	Chicago	Illinois	60611	Recruiting
Norton Children's Medical Center	Louisville	Kentucky	40202	Recruiting
Henry Ford Hospital	Detroit	Michigan	48202	Active, not recruiting
Minnesota Epilepsy Group, P.A.	Roseville	Minnesota	55102	Recruiting
Children's Nebraska	Omaha	Nebraska	68114	Recruiting
Tekton Research	Marlboro	New Jersey	07746	Recruiting
NYU Comprehensive Epilepsy Center - BRANY - PPDS	New York	New York	10016-4852	Recruiting
Weill Cornell Medicine/New York Presbyterian Hospital	New York	New York	10021	Recruiting
Atrium Health STRIVE Research	Charlotte	North Carolina	28207	Recruiting
On-Site Clinical Solution	Charlotte	North Carolina	28211	Recruiting
Duke University Medical Center	Durham	North Carolina	27705	Recruiting
PPD Virtual-Science 37, Inc.	Morrisville	North Carolina	27560	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
UTHealth Houston	Houston	Texas	77030	Recruiting
Clinical Neurosciences Center	Salt Lake City	Utah	84132	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05066217, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 20, 2026 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05066217 live on ClinicalTrials.gov.

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