A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Recruiting now · Phase 3
Conditions studied: Partial Epilepsy
In brief
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Key facts
- Study ID
- NCT07594158
- Run by
- Ono Pharmaceutical Co., Ltd.
- People needed
- 20
- Starts
- 2026-05-30
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-05-18
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Japan Red Cross Fukuoka Hospital — Fukuoka, Japan (enrolling)
Full record on ClinicalTrials.gov
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