Tests EPX-100 with usual medicines in people with Dravet syndrome
Tests EPX-100 alongside usual medicines in children and adults with Dravet syndrome.
Plain-language title generated from the registry record
Registry title: A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Key facts
- Where
- Ann Arbor, Atlanta, Austin, Birmingham, Chicago, Cincinnati, Cleveland, Columbus, Dallas, Durham, Hackensack, Kissimmee, Little Rock, Los Angeles, Louisville, Marlboro, Memphis, Milwaukee, Morrisville, New Haven, New York, Omaha, Orange, Philadelphia, Salt Lake City, San Francisco, Seattle, Wilmington, Winston-Salem, and Winter Park, United StatesSee the 31 sites
- Phase
- Phase 3
Where in United States
- University of Michigan/Mott Children's HospitalAnn Arbor, United StatesNo longer taking part
- Clinical Integrative Research Center of Atlanta (CIRCA)Atlanta, United StatesNo longer taking part
- Child Neurology Consultants of AustinAustin, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Nationwide Children's HospitalColumbus, United StatesNo longer taking part
- UT Southwestern/Children's HealthDallas, United StatesNo longer taking part
- Duke University Health SystemDurham, United StatesTaking people
- Northeast Regional Epilepsy GroupHackensack, United StatesNo longer taking part
- Rare Disease Research FLKissimmee, United StatesNo longer taking part
- Arkansas Children's HospitalLittle Rock, United StatesTaking people
- Children's Hospital of Los AngelesLos Angeles, United StatesNo longer taking part
- Norton Children's Research InstituteLouisville, United StatesTaking people
- Neurology Center for Epilepsy and SeizuresMarlboro, United StatesTaking people
- Le Bonheur Children's HospitalMemphis, United StatesNo longer taking part
- Medical College of Wisconsin, Children's WisconsinMilwaukee, United StatesNot yet recruiting
- Science 37Morrisville, United StatesTaking people
- Yale School of Medicine - Yale-New Haven HospitalNew Haven, United StatesTaking people
- Northwell Health- Lenox Hill HospitalNew York, United StatesNo longer taking part
- Weill Cornell Medical CenterNew York, United StatesNo longer taking part
- Children's NebraskaOmaha, United StatesTaking people
- University of California IrvineOrange, United StatesTaking people
- The Children's Hospital Of PhiladelphiaPhiladelphia, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- UCSF Medical CenterSan Francisco, United StatesNo longer taking part
- Seattle Children's HospitalSeattle, United StatesTaking people
- The Nemours FoundationWilmington, United StatesNo longer taking part
- Wake Forest Baptist Medical CenterWinston-Salem, United StatesTaking people
- Pediatric Neurology and Epilepsy SpecialistsWinter Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Epygenix
- Trial code
- NCT04462770EU 2024-518628-57-00
- Record updated
- 29 October 2026
- Original description
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).Read full original descriptionShow less
A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)
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).
Inclusion: 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.
Exclusion: 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.