An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

Recruiting Phase 3 Interventional Study
Lennox Gastaut Syndrome
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 55
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
Epygenix · Industry
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About This Trial

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: 1. Males or females, ages ≥2 to ≤55 years, at the time of Screening. 2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent. 3. Diagnosis of LGS, including: * Evidence of at least one type of countable major m…
Contacts

Juby Philip

(302) 559-4320

clinicaltrials@harmonybiosciences.com

CONTACT

Cindy Sandy

(317) 258-7262

clinicaltrials@harmonybiosciences.com

CONTACT