What is clemizole HCl studying for Lennox-Gastaut syndrome?

Clemizole HCl is being studied as an additional treatment for Lennox-Gastaut syndrome to evaluate its safety and effectiveness in reducing seizures. This Phase 3 study is sponsored by Epygenix and aims to provide more options for managing this condition. Participants will receive either clemizole or a placebo to compare outcomes.

Who may be eligible for this Lennox-Gastaut syndrome clinical trial?

Participants aged 2 to 55 years with a diagnosis of Lennox-Gastaut syndrome may be eligible. Both males and females can join if they have specific seizure types and abnormal EEG findings. People with certain heart conditions or allergies to clemizole are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Lennox-Gastaut syndrome clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any out-of-pocket costs.

Actively Recruiting

Phase 3

Age: 2Years - 55Years

All Genders

ID05066217

Phase 3 Study Evaluating Clemizole HCl as Additional Treatment for Lennox-Gastaut Syndrome in Children and Adults Ages 2 to 55

Led by Epygenix · Updated on 2026-07-02

260

Participants Needed

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating clemizole HCl as an additional treatment for children and adults aged 2 to 55 years who have Lennox-Gastaut syndrome LGS, a condition characterized by seizures and abnormal brain activity. This Phase 3 trial aims to assess how well clemizole HCl works and how safe it is when added to existing treatments. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will go through three main phases an Observational Period, a Double-Blind Period, and an optional Open-Label Extension. During the Double-Blind Period, participants receive either clemizole HCl or a placebo as an oral solution. Those who complete this phase may continue to receive clemizole HCl for up to three years in the Open-Label Extension Phase. Throughout the study, participants will be monitored closely with various assessments, including measuring seizure frequency using the CMMS-28 scale over up to 16 weeks. Researchers will also check global impressions of change, quality of life scores, and record any treatment-emergent side effects. The studys overall duration may last up to several years, allowing for long-term safety and effectiveness monitoring.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 2Years - 55Years

All Genders

Eligibility Criteria

You may qualify if you...

Males or females aged 2 to 55 years at screening
Participant or legal representative willing and able to provide written informed consent or assent
Diagnosis of Lennox-Gastaut syndrome with at least one type of countable major motor seizure
History of EEG consistent with Lennox-Gastaut syndrome showing abnormal background activity and either slow spike-wave discharges (<2.5 Hz) or paroxysmal fast activity during sleep
Abnormal cognitive development
Seizure onset at age 11 years or younger

You will not qualify if you...

Known allergy, sensitivity, or previous exposure to clemizole HCl
History of long QT syndrome or serious ECG abnormalities (e.g., recent heart attack, significant arrhythmia)
Family history of sudden cardiac death or deaths related to QT prolongation
Seizures caused by drug or alcohol use, infection, tumors, neurological diseases, metabolic illness, recent anoxic episode requiring resuscitation, or progressive degenerative disease
Planned epilepsy surgery during the study or surgery within 6 months before screening
Use of fenfluramine
Prior or current use of lorcaserin

Research Team

Juby Philip

Cindy Sandy

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