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)

Epygenix Therapeutics, Inc8 个研究点分布在 1 个国家目标入组 150 人开始时间: 2026年1月16日最近更新: 2025年12月30日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: Epygenix Therapeutics, Inc
入组人数: 150
试验地点: 8

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

研究设计

研究类型: Interventional
分配方式: Other
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 2.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•1.Male and female participants 2 years and older at time of consent.
•2.Participant or parent or Legally Authorized Representative (LAR) willing and able to provide written informed consent, assent (if applicable) prior to initiation of any study related procedures.
•3.Clinical diagnosis of DS.
•Participants must have seizures which are not completely controlled by antiepileptic drugs (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 4.Brain magnetic resonance imaging (MRI) without cortical malformation (not including mild atrophy associated with the natural progression of DS), Genetic mutation of the SCN1A gene must be documented.

排除标准

•1.Known sensitivity, allergy, or previous exposure to clemizole HCl. 2.Exposure to any investigational drug or device less than 90 days prior to screening or plans to participate in another drug or device trial at any time during the study.
•3.Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol 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.
•4.Concurrent use of lorcaserin.
•Note Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.
•5.Concurrent use of fenfluramine.
•6.Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.

研究者

发起方

Epygenix Therapeutics, Inc

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

主要研究者

Umakanta Sahoo

GCT Pharma Research (India) Pvt Ltd

研究点 (8)

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