Tests clemizole as add-on treatment for Lennox-Gastaut syndrome
Tests clemizole against placebo in children and adults with Lennox-Gastaut syndrome.
Plain-language title generated from the registry record
Registry title: An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Key facts
- Where
- Catanzaro, Florence, Genoa, Milan, Pavia, and Pozzilli, ItalySee the 7 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 55 years old?
Source: NCT05066217, who can take part
Where in Italy
- Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater DominiCatanzaro, ItalyTaking people
- Azienda Ospedaliero Universitaria A. MeyerFlorence, ItalyTaking people
- IRCCS Azienda Ospedaliera MetropolitanGenoa, ItalyTaking people
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
- Fondazione IRCCS Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCSPavia, ItalyTaking people
- IRCCS Istituto Neurologico Mediterraneo NeuromedPozzilli, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Epygenix
- Trial code
- NCT05066217
- Record updated
- 9 October 2026
- Original description
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).Read full original descriptionShow less
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
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).
Inclusion: 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: Known sensitivity, allergy, or previous exposure to clemizole HCl; 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; 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; 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.