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

Launched by EPYGENIX · Sep 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called clemizole HCl, which is being tested as an add-on treatment for people with Lennox-Gastaut syndrome (LGS), a type of epilepsy that causes multiple types of seizures and often involves developmental delays. The trial is designed to find out if clemizole can help reduce seizures in both children and adults aged 2 to 55 who have LGS. Participants will be randomly assigned to receive either the medication or a placebo (a non-active treatment) without knowing which one they got, helping researchers determine the effectiveness of clemizole.

To be eligible for the trial, participants must be diagnosed with LGS and have experienced at least one major type of seizure. They also need to have specific EEG results that support the diagnosis and show signs of cognitive development issues. However, individuals with certain medical histories, such as previous severe reactions to clemizole or significant heart problems, cannot participate. Those who join the trial can expect regular follow-up visits and assessments to monitor their health and seizure activity during the study. This trial is currently recruiting participants, and your involvement could contribute to understanding better treatments for LGS.

Gender

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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 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.
• Key Exclusion Criteria:
• • 1. Known sensitivity, allergy, or previous exposure to clemizole HCl.
• • 2. 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).
• • 3. Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
• • 4. 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.
• • 5. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
• • 6. Concomitant use of fenfluramine.
• • 7. Prior or concomitant use of lorcaserin.