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RecruitingPhase 3

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

Epygenix · with Harmony Biosciences Management, Inc. · NCT05066217

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
260
US sites recruiting
17
Study start
April 9, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Clemizole HCl; Placebo

Conditions: Lennox Gastaut Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • Males or females, ages ≥2 to ≤55 years, at the time of Screening.
  • Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
  • 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

  • Known sensitivity, allergy, or previous exposure to clemizole HCl.
  • 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).
  • Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
  • 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.
  • Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
  • Concomitant use of fenfluramine.
  • Prior or concomitant use of lorcaserin.

Recruiting US locations

  • University of Miami Miller School of Medicine

    Miami, FL 33136

    Site contact: Brett Alonso Cardenas · 305-243-3100 · bac301@med.miami.edu

  • AdventHealth Innovation Tower

    Orlando, FL 32804

    Site contact: Holly Skinner, DO

  • Re:Cognition Health

    Chicago, IL 60611

    Site contact: Antonio Iglesias, MD · 312-971-3318 · aiglesias@re-cognitionhealth.com

  • Norton Children's Medical Center

    Louisville, KY 40202

    Site contact: Madeline McGinty-Holmes · 502-629-5568 · madeline.mcginty-holmes@louisville.edu

  • Minnesota Epilepsy Group, P.A.

    Roseville, MN 55102

    Site contact: Sarah Ellis, MD · 651-377-8319 · sellis@mnepilepsy.net

  • Children's Nebraska

    Omaha, NE 68114

    Site contact: Sookyong Koh, MD, PhD · 773-929-4445 · skoh@childrensnebraska.org

  • Tekton Research

    Marlboro, NJ 07746

    Site contact: Aimee Kinlan · 626-218-8294 · aimee.kinlan@tektonresearch.com

  • NYU Comprehensive Epilepsy Center - BRANY - PPDS

    New York, NY 10016-4852

    Site contact: Dana Price

  • Weill Cornell Medicine/New York Presbyterian Hospital

    New York, NY 10021

    Site contact: Lundy Santil · 800-785-3150 · ludny.saintil@thermofisher.com

  • Atrium Health STRIVE Research

    Charlotte, NC 28207

    Site contact: Jessica Lindley · Jessica.Lindley@atriumhealth.org

  • On-Site Clinical Solution

    Charlotte, NC 28211

    Site contact: Ludny Saintil · 800-785-3150 · ludny.santil@thermofischer.com

  • Duke University Medical Center

    Durham, NC 27705

    Site contact: Muhammad Zafar, MD · muhammad.zafar@duke.edu

  • PPD Virtual-Science 37, Inc.

    Morrisville, NC 27560

    Site contact: Victoria Taylor · 615-707-9148 · victoria.taylor@science37.com

  • Children's Hospital of Philadelphia

    Philadelphia, PA 19104

    Site contact: Eric Marsh, MD

  • Children's Health Specialty Center

    Dallas, TX 75235

    Site contact: Charuta Joshi

  • UTHealth Houston

    Houston, TX 77030

    Site contact: Antoinette Bernal-Tent · 713-500-7105 · Antoinette.BernalTent@uth.tmc.edu

  • Clinical Neurosciences Center

    Salt Lake City, UT 84132

    Site contact: Angela Peters, MD

Study contacts (from the official record)

  • Juby Philip · (302) 559-4320 · clinicaltrials@harmonybiosciences.com
  • Cindy Sandy · (317) 258-7262 · clinicaltrials@harmonybiosciences.com
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An Efficacy and Safety Study of Clemizole HCl in Patients With… (NCT05066217) | Bored Studies