An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clemizole HCl, Placebo.
- Who it may be relevant to
- Registry conditions: Lennox Gastaut Syndrome. Basic parameters: 2 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy, Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
Overview
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).
Detailed description
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCl as adjunctive therapy in children and adult participants with LGS.
The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.
Interventions
- Drug Clemizole HCl
Clemizole HCl will be administered as an oral solution. - Drug Placebo
Placebo will be administered as an oral solution.
Primary outcome measures
- Percent Change in CMMS-28 [Time frame: From Baseline Period up to 16 weeks]
Secondary outcome measures (10)
- Proportion of Participants with ≥50% Reduction in CMMS-28 [Time frame: From Baseline Period up to 16 weeks]
- Percent Change in CMMS-28 Seizure-free Days [Time frame: From Baseline Period up to 16 weeks]
- Clinical Global Impression of Change (CGI-C) Score [Time frame: Week 16]
- Caregiver Global Impression of Change (CaGI-C) Score [Time frame: Week 16]
- Caregiver Global Impression of Change in Seizure Intensity/Duration (CaGI-CSID) Score [Time frame: Week 16]
- Change in Quality of Life Inventory (QI)-Disability Score [Time frame: From Baseline Period up to 16 weeks]
- Percent Change per 28 Days in the Number of Seizure Free Days [Time frame: From Baseline Period up to 16 weeks]
- Percent Change in CMMS-28 [Time frame: From Baseline Period up to 12 weeks]
- Proportion of Participants with ≥50% Reduction in CMMS-28 [Time frame: From Baseline Period up to 12 weeks]
- Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: From the first dose administration of study drug up to end of the study, approximately up to 172 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 24 centers
- Arkansas Children's Hospital — Little Rock
- UC Irvine Medical Center — Orange
- UCI Center for Innovative Health Therapies — Orange
- Nemours Children's Health — Wilmington
- Rare Disease Research — Kissimmee
- University of Miami Miller School of Medicine — Miami
- AdventHealth Innovation Tower — Orlando
- Pediatric Neurology and Epilepsy Specialists — Winter Park
- … and 16 more centers
Italy · 1 center
- IRCCS Istituto Neurologico Mediterraneo Neuromed — Pozzilli
Poland · 1 center
- Neurosphera — Warsaw
Identifiers
NCT: NCT05066217 · EPX-100-003