Kid-focused cenobamate for partial seizures in kids 2 to 17

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial evaluates cenobamate in Japanese pediatric patients with partial-onset seizures. It compares tablet and syrup formulations over a treatment period to assess safety, tolerability, and preliminary efficacy, along with pharmacokinetics. Eligible participants are 2 to under 18 years old, have uncontrolled partial seizures for at least 6 months, and are on stable anti-seizure medications. Key outcomes include seizure frequency reduction and how the drug is processed in the body. The study is conducted at a Japanese site led by Ono Pharmaceutical in collaboration with local investigators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
* Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
* Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
* Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.

Exclusion Criteria:

* Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
* Patients with a history of non-epileptic psychogenic seizures.
* Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
* Patients diagnosed with Lennox-Gastaut syndrome.
* Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome \[DIHS\]) or drug-induced rash requiring hospitalization.

Where it's running

• Japan Red Cross Fukuoka Hospital
  Fukuoka, Japan Recruiting

Study contacts

• Study coordinator: North America Clinical Trial Support Desk
• Email: clinical_trial@ono-pharma.com
• Phone: +18665877745 (Toll-Free)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.