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New drug shows promise for rare, severe childhood epilepsy

NCT ID NCT05066217

Disease control Sponsor: Epygenix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 4 times

Summary

This study tests whether clemizole HCl (EPX-100) can safely reduce seizures when added to current treatments for Lennox-Gastaut syndrome, a severe form of epilepsy. About 260 children and adults aged 2 to 55 will receive either the drug or a placebo. The main goal is to measure changes in seizure frequency over the treatment period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Males or females, ages ≥2 to ≤55 years, at the time of Screening. 2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent. 3. Diagnosis of LGS, including: * Evidence of at least one type of countable major motor seizure. * History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\<2.5 Hz\], or 2) paroxysmal fast activity during sleep). * Abnormal cognitive development. * Onset of seizures at 11 years of age or younger. Key Exclusion Criteria: 1. Known sensitivity, allergy, or previous exposure to clemizole HCl. 2. Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial infarction, clinically significant arrhythmia). 3. Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member. 4. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control. 5. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening. 6. Concomitant use of fenfluramine. 7. Prior or concomitant use of lorcaserin.

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Conditions

The condition(s) this trial relates to.

Lennox-Gastaut syndrome visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lennox Gastaut syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    54 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • AdventHealth Innovation Tower

    RECRUITING

    Orlando, Florida, 32804, United States

  • Arkansas Children's Hospital

    ACTIVE_NOT_RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Atrium Health STRIVE Research

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini

    RECRUITING

    Catanzaro, 88100, Italy

  • Azienda Ospedaliero Universitaria A Meyer

    RECRUITING

    Florence, 50139, Italy

  • Beijing Children's Hospital, Capital Medical University - PIN

    RECRUITING

    Beijing, 100045, China

  • Centro de Neurologia Avanzada

    RECRUITING

    Seville, 41013, Spain

  • Centrul National Clinic De Recuperare Neuropsihomotorie Copii Robanescu-Padure

    RECRUITING

    Bucharest, 041408, Romania

  • Centrum Medyczne Plejady Magdalena Celinska

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-363, Poland

  • Chengdu Women's and Children's Central Hospital

    RECRUITING

    Chengdu, 610073, China

  • Children and Youth Health Care Institute of Vojvodina

    RECRUITING

    Novi Sad, 21000, Serbia

  • Children's Health Specialty Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • Children's Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, 400014, China

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Nebraska

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Childrens University Hospital

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Neurosciences Center

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Emergency University Hospital

    RECRUITING

    Bucharest, 050098, Romania

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, 20133, Italy

  • Henry Ford Hospital

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Infantil Universitario Niño Jesus - PIN

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Regional Universitario de Malaga - Hospital General

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital de La Santa Creu i Sant Pau

    RECRUITING

    Barcelona, 08025, Spain

  • Hunan Children's Hospital

    RECRUITING

    Changsha, 410007, China

  • IRCCS Azienda Ospedaliera Metropolitan

    RECRUITING

    Genoa, Liguria, 16132, Italy

  • IRCCS Istituto Neurologico Mediterraneo Neuromed

    RECRUITING

    Pozzilli, Molise, 86077, Italy

  • Jiangxi Provincial Children's Hospital

    RECRUITING

    Nanchang, 330006, China

  • Minnesota Epilepsy Group, P.A.

    RECRUITING

    Roseville, Minnesota, 55102, United States

  • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

    RECRUITING

    Belgrade, 11000, Serbia

  • NYU Comprehensive Epilepsy Center - BRANY - PPDS

    RECRUITING

    New York, New York, 10016-4852, United States

  • Neurosphera

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-829, Poland

  • Norton Children's Medical Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • On-Site Clinical Solution

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • PPD Virtual-Science 37, Inc.

    RECRUITING

    Morrisville, North Carolina, 27560, United States

  • Pediatric Neurology and Epilepsy Specialists

    ACTIVE_NOT_RECRUITING

    Winter Park, Florida, 32789, United States

  • Peking University First Hospital - Changqiao Campus

    RECRUITING

    Beijing, 100034, China

  • Peking University First Hospital - Daxing Campus

    RECRUITING

    Beijing, 100034, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, 250012, China

  • Rare Disease Research

    SUSPENDED

    Orlando, Florida, 34746, United States

  • Re:Cognition Health

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Sf. Maria Children Emergency Clinical Hospital Iasi

    RECRUITING

    Iași, 700309, Romania

  • Shenzhen Children's Hospital

    RECRUITING

    Shenzhen, 518000, China

  • Tekton Research

    RECRUITING

    Marlboro, New Jersey, 07746, United States

  • The Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, 550004, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, 130021, China

  • The Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, 510260, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, 710004, China

  • UC Irvine Medical Center

    ACTIVE_NOT_RECRUITING

    Orange, California, 92868, United States

  • UTHealth Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University Clinical Center Nis

    RECRUITING

    Niš, 18 000, Serbia

  • University of Miami Miller School of Medicine

    RECRUITING

    Miami, Florida, 33136, United States

  • Weill Cornell Medicine/New York Presbyterian Hospital

    RECRUITING

    New York, New York, 10021, United States

  • West China Second University Hospital, Sichuan University - Huaxi Campus

    RECRUITING

    Chengdu, 610041, China

  • Wuhan Children's Hospital

    RECRUITING

    Wuhan, 430015, China

  • Xuzhou Children's Hospital

    RECRUITING

    Xuzhou, 221006, China

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Other studies related to the condition(s) this trial covers.