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
- Campinas, São José do Rio Preto, and São Paulo, BrazilSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and adults with Dravet syndrome whose seizures are not fully controlled by their current seizure medicines.
- Age
- 2 years and older
- Sex
- Men and women can join
- Disease stage
- Clinical diagnosis of Dravet syndrome. Seizures not completely controlled by seizure medicines. First seizures before 18 months of age and normal development at that time. At least one type of countable motor seizure. Brain MRI without cortical malformation.
- Earlier treatment
- Cannot have used clemizole HCl before. Cannot have used lorcaserin at the same time; earlier use is fine if at least 30 days have passed since the last dose. Cannot be using fenfluramine at the same time.
- Biomarker or test result
- A mutation of the SCN1A gene must be documented.
Main reasons for not taking part
- Known sensitivity or allergy to clemizole HCl, or earlier use of it
- Any investigational drug or device in the 90 days before screening, or plans to join another drug or device trial
- Seizures caused by illicit drugs, THC, nonprescription cannabidiol, alcohol, infection, tumour or a progressive brain or metabolic disease
- Using lorcaserin or fenfluramine at the same time
- Epilepsy surgery planned during the study or within 6 months before screening
Read by machine on 9 November 2026.
Where in Brazil
- Hospital Universitário da Universidade Estadual de Campinas - UNICAMPCampinas, BrazilNot yet recruiting
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDSSão José do Rio Preto, BrazilNot yet recruiting
- Hospital São Paulo da Universidade Federal de Sao Paulo - Escola Paulista de Medicina UNIFESP-EPMSão Paulo, BrazilNot yet recruiting
- Instituto de Psiquiatria HC FMUSPSão Paulo, BrazilNot yet recruiting
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.