NCT07594158 A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
| NCT ID | NCT07594158 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ono Pharmaceutical Co., Ltd. |
| Condition | Partial Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-30 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 20 participants in total. It began in 2026-05-30 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
North America Clinical Trial Support Desk
✉ clinical_trial@ono-pharma.com📞 +18665877745 (Toll-Free)
Project Leader
STUDY DIRECTOR
Ono PharmaceuticalCo., Ltd.
Frequently Asked Questions
Who can join the NCT07594158 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Partial Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07594158 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 20 participants.
Is NCT07594158 currently recruiting?
Yes, NCT07594158 is actively recruiting participants. Contact the research team at clinical_trial@ono-pharma.com for enrollment information.
Where is the NCT07594158 trial being conducted?
This trial is being conducted at Fukuoka, Japan.
Who is sponsoring the NCT07594158 clinical trial?
NCT07594158 is sponsored by Ono Pharmaceutical Co., Ltd.. The principal investigator is Project Leader at Ono PharmaceuticalCo., Ltd.. The trial plans to enroll 20 participants.
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