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Study identifier: NCT04462770 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Dravet Syndrome  ·  Sponsor: Epygenix

PhasePhase 3
Planned participants150
Who can joinAll sexes, 2 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

Krystle Rapchak  ·  +1 (312) 847-1289  ·  clinicaltrials@harmonybiosciences.com

Eric Bauer  ·  clinicaltrials@harmonybiosciences.com

Always discuss trial participation with your own doctor first.

Locations (60)

University of Alabama at BirminghamBirmingham, Alabama, United StatesActive Not Recruiting
Arkansas Children's HospitalLittle Rock, Arkansas, United StatesActive Not Recruiting
Children's Hospital of Los AngelesLos Angeles, California, United StatesTerminated
University of California IrvineOrange, California, United StatesRecruiting
UCSF Medical CenterSan Francisco, California, United StatesRecruiting
Yale University School of MedicineNew Haven, Connecticut, United StatesNot Yet Recruiting
Yale School of Medicine - Yale-New Haven HospitalNew Haven, Connecticut, United StatesRecruiting
The Nemours FoundationWilmington, Delaware, United StatesTerminated
Rare Disease Research FLKissimmee, Florida, United StatesRecruiting
Pediatric Neurology and Epilepsy SpecialistsWinter Park, Florida, United StatesRecruiting
Clinical Integrative Research Center of Atlanta (CIRCA)Atlanta, Georgia, United StatesWithdrawn
Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois, United StatesTerminated

+ 48 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04462770