RecruitingPhase 3

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

United States150 participantsStarted 2020-09-15

Plain-language summary

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).

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. 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, 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:

Exclusion criteria

✕. 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.

What they're measuring

Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline

Timeframe: From Baseline Period (Day 1) up to 16 weeks

European Union: Percent Change in Countable Motor Seizures Per 28 Days in the Maintenance Period Relative to Baseline

Timeframe: From maintenance period Baseline (Day 29) up to Day 85

Trial details

NCT IDNCT04462770

SponsorEpygenix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Krystle Rapchak

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

View on ClinicalTrials.gov More Dravet Syndrome trials