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
- Odunpazari and Ortahisar, TürkiyeSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and adults aged 2 to 55 with Lennox-Gastaut syndrome (LGS), a severe form of epilepsy. Clemizole HCl or placebo is added to their current treatment.
- Age
- 2 to 55 years
- Sex
- Women and men can join.
- Disease stage
- A diagnosis of Lennox-Gastaut syndrome: at least one type of countable major motor seizure, an EEG consistent with LGS, abnormal cognitive development, and seizures starting at 11 years of age or younger.
- Earlier treatment
- People with previous exposure to clemizole HCl cannot join. Prior or current use of lorcaserin and current use of fenfluramine are not allowed.
Main reasons for not taking part
- Known allergy or sensitivity to clemizole HCl, or previous use of it
- Long QT syndrome or a serious abnormality on the heart tracing (ECG)
- Family history of sudden cardiac death or unexplained death
- Seizures caused by another condition, such as drug or alcohol use, infection, tumour or progressive brain disease
- Epilepsy surgery planned during the study or within 6 months before screening
Read by machine on 12 November 2026.
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 Türkiye
- Eskisehir Osmangazi Universitesi Saglik Uygulama ve Arastirma HastanesiOdunpazari, TürkiyeContact: Kursat Carman (principal investigator)Taking people
- Karadeniz Teknik Üniversitesi Farabi HastanesiOrtahisar, TürkiyeContact: Ali Cansu (principal investigator)Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.