Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
Epygenix
Summary
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).
Description
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCl as adjunctive therapy in children and adult participants with LGS. The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.
Eligibility
- Age range
- 2–55 years
- Sex
- All
- Healthy volunteers
- No
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 motor seizure. * History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\<2.5 Hz\], or 2) paroxysmal fast activity during sleep). * Abnormal cognitive development. * Onset of seizures at 11 years of a…
Interventions
- DrugClemizole HCl
Clemizole HCl will be administered as an oral solution.
- DrugPlacebo
Placebo will be administered as an oral solution.
Locations (20)
- Arkansas Children's HospitalLittle Rock, Arkansas
- UC Irvine Medical CenterOrange, California
- UCI Center for Innovative Health TherapiesOrange, California
- Nemours Children's HealthWilmington, Delaware
- Rare Disease ResearchKissimmee, Florida
- University of Miami Miller School of MedicineMiami, Florida