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RecruitingPhase 3

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

Epygenix · with Harmony Biosciences Management, Inc. · NCT04462770

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
150
US sites recruiting
17
Study start
September 15, 2020
Record last updated
September 15, 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 hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

Being studied: Clemizole HCl; Placebo

Conditions: Dravet Syndrome

Eligibility criteria

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

Show full criteria

Key Inclusion Criteria

  • Male and female participants 2 years and older at time of consent.
  • Participant or parent/legally authorized representative (LAR) willing and able to provide written informed consent and assent (if applicable) prior to initiation of any study related procedures.
  • Clinical diagnosis of DS. Participants must have seizures which are not completely controlled by AEDs with the following criteria:
  • Onset of seizures prior to 18 months of age,
  • Normal development at onset,
  • History of at least one type of countable motor seizure (CMS),
  • Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of DS),
  • Genetic mutation of the SCN1A gene must be documented.

Key Exclusion Criteria

  • Known sensitivity, allergy, or previous exposure to clemizole HCl.
  • Exposure to any investigational drug or device \<90 days prior to screening or plans to participate in another drug or device trial at any time during the study.
  • Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol [THC] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.
  • Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.
  • Concurrent use of fenfluramine.
  • Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35233

    Site contact: Kathryn Lalor, MD · 205-586-4464 · klalor@uabmc.edu

  • Arkansas Children's Hospital

    Little Rock, AR 72202

    Site contact: Debopam Samanta, MD · 501-364-1850 · dsamanta@uams.edu

  • University of California Irvine

    Orange, CA 92868

    Site contact: Madeline Pak · 714-456-8413 · mspak@hs.uci.edu

  • Yale School of Medicine - Yale-New Haven Hospital

    New Haven, CT 06511

    Site contact: Aline Herlopian, MD

  • Pediatric Neurology and Epilepsy Specialists

    Winter Park, FL 32789

    Site contact: Alex Rivera · 407-293-1122 · ariveradelvalle@pediatricneurologyandepilepsy.com

  • Norton Children's Research Institute

    Louisville, KY 40202

    Site contact: Katie Harris · 502-629-5820 · katherine.bellamy@louisville.edu

  • Children's Nebraska

    Omaha, NE 68114

    Site contact: Kym Abraham · 402-559-2977 · kabraham@unmc.edu

  • Neurology Center for Epilepsy and Seizures

    Marlboro, NJ 07746

    Site contact: Aimee Kinlan · 732-201-6179 · Amy.Kinlan@tektonresearch.com

  • Duke University Health System

    Durham, NC 27710

    Site contact: Amanda Fristoe · 919-613-0767 · amanda.fristoe@duke.edu

  • Science 37

    Morrisville, NC 27560

  • Wake Forest Baptist Medical Center

    Winston-Salem, NC 27157

    Site contact: Tonya Woosley · 336-716-8940 · twoosley@wakehealth.edu

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 45229

    Site contact: Samantha Ballard, BSN, RN, CPN · 513-803-3177 · samantha.ballard@cchmc.org

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Honglian Huang, PhD · 216-445-2366 · huangh2@ccf.org

  • The Children's Hospital of Philadelphia

    Philadelphia, PA 19104

    Site contact: Rashmi Risbud, Mbio · 215-419-3212 · risbudr@chop.edu

  • Child Neurology Consultants of Austin

    Austin, TX 78757

    Site contact: Victoria Henderson, BS · 210-416-4163 · Victoria.Henderson@childneurotx.com

  • University of Utah

    Salt Lake City, UT 84112

    Site contact: Laura Beeler, BS · 801-585-2121 · laura.beeler@hsc.utah.edu

  • Seattle Children's Hospital

    Seattle, WA 98105

    Site contact: Laurie Guidry, RN · 206-987-0058 · laurie.guidry@seattlechildrens.org

Study contacts (from the official record)

  • Krystle Rapchak · +1 (312) 847-1289 · clinicaltrials@harmonybiosciences.com
  • Eric Bauer · clinicaltrials@harmonybiosciences.com
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A Study of EPX-100 (Clemizole Hydrochloride) in Participants With… (NCT04462770) | Bored Studies