A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds

NCT07594158 · tracked via the Priya Life Science Japan tracker

Sponsor

Ono Pharmaceutical Co., Ltd

Phase

Phase 3

Started

2026-06-10

Last updated

2026-10-09

Condition(s) studied

Partial Epilepsy

Investigational drug(s) / intervention(s)

Cenobamate (tablet) for 12 to < 18 year oldsCenobamate (syrup) for 2 to < 18 year olds

Cenobamate (tablet) for 12 to < 18 year olds: The tablet form of ONO-2017 will be initiated at a dose of 12.5 mg once daily and titrated in the specified method to a target dose of 200 mg per day. The daily dose may be increased/reduced as appropriate according to symptoms within the range not exceeding 400 mg. In addition, depending on clinical response and tolerability, dose titration may be stopped at a dose of ≥ 50 mg per day to establish the maintenance dose. In principle, all doses should be taken with an appropriate amount of water in the morning. The dosage form for the doses will be selected by the principal investigator or designee. ONO-2017 can be treated until ONO-2017 is market approved, enters the market, and becomes available for supply to the study site.

Cenobamate (syrup) for 2 to < 18 year olds: The syrup form of ONO-2017 will be administered at a dose equivalent to that for 12-18 year olds on a body weight basis

Study summary

Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Eligibility

Sex

ALL

Min age

2 Years

Max age

17 Years

Healthy volunteers

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.

Primary outcome measure(s)

Adverse events and adverse drug reactions — 1 year

Trial sites (1)

Facility	City	Region	Status
Japan Red Cross Fukuoka Hospital	Fukuoka	Japan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07594158 on ClinicalTrials.gov ↗ ← All trials in Japan