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

ConditionLennox Gastaut Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-55
SponsorEpygenix

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clemizole HCl

    Drug

    Clemizole HCl will be administered as an oral solution.

  • Placebo

    Drug

    Placebo will be administered as an oral solution.

Treatment groups

260 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Double-blind clemizole HClExperimental treatment 1 intervention
Group C: Open-label clemizole HClExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change in CMMS-28

Percent change in CMMS-28 from the Baseline Period through the end of the DB Period

Time frame
From Baseline Period up to 16 weeks

Secondary outcomes

1

Proportion of Participants with ≥50% Reduction in CMMS-28

Proportion of participants with ≥50% reduction in CMMS-28 from the Baseline Period through the end of the DB Period

Time frame
From Baseline Period up to 16 weeks
2

Percent Change in CMMS-28 Seizure-free Days

Percent change in CMMS-28 seizure-free days from the Baseline Period through the end of the DB Period

Time frame
From Baseline Period up to 16 weeks
3

Clinical Global Impression of Change (CGI-C) Score

CGI-C score at the end of the DB Period

Time frame
Week 16
4

Caregiver Global Impression of Change (CaGI-C) Score

CaGI-C score at the end of the DB Period

Time frame
Week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Epygenix

Lead sponsor

Harmony Biosciences Management, Inc.

Collaborator

Source ClinicalTrials.gov
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