Cenobamate for Partial-Onset Seizures in Japanese Children and Teenagers
Tests cenobamate in Japanese children and teenagers with partial-onset seizures.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Key facts
- Where
- Fukuoka, JapanSee the site
- 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 Japanese children and teenagers aged 2 to under 18 with partial-onset seizures that are not controlled, to test the safety of cenobamate.
- Age
- 2 to under 18 years
- Sex
- Boys and girls can both join.
- Disease stage
- Epilepsy with partial-onset seizures, not controlled for at least 6 months before consent. At least one partial-onset seizure in the 4 weeks before registration.
- Earlier treatment
- Must have taken 1 to 3 anti-seizure medicines at stable doses for at least 2 months before registration.
Main reasons for not taking part
- Hospital stay for status epilepticus within 3 months before registration
- History of non-epileptic psychogenic seizures
- Simple partial seizures without motor symptoms, or idiopathic generalized epilepsy
- Lennox-Gastaut syndrome
- Serious drug allergic reaction (such as Stevens-Johnson syndrome) or drug rash needing hospital care
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 17 years old?
Source: NCT07594158, who can take part
Where in Japan
- Japan Red Cross Fukuoka HospitalFukuoka, JapanContact: North America Clinical Trial Support DeskTaking 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
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT07594158
- Record updated
- 9 October 2026
- Original description
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizuresRead full original descriptionShow less
A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Inclusion: 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: 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.