NCT05066217 An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
| NCT ID | NCT05066217 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Epygenix |
| Condition | Lennox Gastaut Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-04-09 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 260 participants in total. It began in 2025-04-09 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Amit Ray, MD
STUDY DIRECTOR
Harmony Biosciences Management, Inc.
Frequently Asked Questions
Who can join the NCT05066217 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 55 Years, studying Lennox Gastaut Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05066217 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 260 participants.
Is NCT05066217 currently recruiting?
Yes, NCT05066217 is actively recruiting participants. Contact the research team at clinicaltrials@harmonybiosciences.com for enrollment information.
Where is the NCT05066217 trial being conducted?
This trial is being conducted at Little Rock, United States, Orange, United States, Miami, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT05066217 clinical trial?
NCT05066217 is sponsored by Epygenix. The principal investigator is Amit Ray, MD at Harmony Biosciences Management, Inc.. The trial plans to enroll 260 participants.