A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
ConditionDravet Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorEpygenix
About this 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).
Eligibility criteria
Qualifiers
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.
Onset of seizures prior to 18 months of age,
Normal development at onset,
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Clemizole HCl
- Placebo
Treatment groups
150 Participants
are divided into 3 treatment groupsSponsors and collaborators
Epygenix
Lead sponsor
Harmony Biosciences Management, Inc.
Collaborator
Source ClinicalTrials.gov