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
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, JapanTaking 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?
Trial 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.