NCT07594158RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
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.
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 11 May 2026
- Start date
- Jun 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Epilepsy
- NCT number
- NCT07594158
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 20
- From Jun 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Japan Red Cross Fukuoka Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.