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NCT05066217
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Conditions: Lennox Gastaut Syndrome
Sex: All
Ages: 2 Years – 55 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 260
Sponsor: Epygenix
Location: Arkansas Children's Hospital Little Rock Arkansas
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).
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 motor seizure.
* History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\
Source: ClinicalTrials.gov (NCT05066217). StuddyBuddy aggregates publicly available trial information.
