RecruitingPhase 3NCT05066217
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
Sponsor
Epygenix
Enrollment
260 participants
Start Date
Apr 9, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 2 YearsMax Age: 55 Years
Inclusion Criteria7
- Males or females, ages ≥2 to ≤55 years, at the time of Screening.
- Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
- 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 age or younger.
Exclusion Criteria7
- Known sensitivity, allergy, or previous exposure to clemizole HCl.
- Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial infarction, clinically significant arrhythmia).
- Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
- Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control.
- Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
- Concomitant use of fenfluramine.
- Prior or concomitant use of lorcaserin.
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Interventions
DRUGClemizole HCl
Clemizole HCl will be administered as an oral solution.
DRUGPlacebo
Placebo will be administered as an oral solution.
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT05066217
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