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
- Ottawa, Toronto, and Vancouver, CanadaSee the 4 sites
- Phase
- Phase 3
Where in Canada
- Children's Hospital of Eastern Ontario Research Institute Inc.Ottawa, CanadaTaking people
- The Hospital for Sick ChildrenToronto, CanadaTaking people
- Toronto Western Hospital, University Health NetworkToronto, CanadaTaking people
- UBC Children's Hospital Research InstituteVancouver, CanadaTaking 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.