Evaluating the safety of cenobamate for Japanese patients with partial seizures
Official title: A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
Run by Ono Pharmaceutical Co., Ltd. · NCT06590896 · Data updated 2026-11-12
This study is testing how safe cenobamate is for Japanese patients with partial seizures who have already taken part in a related study.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ono Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 29 sites (Ehime and 28 other locations) |
| Status | Recruiting |
| Started | November 4, 2022 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | June 3, 2025 |
| Trial ID | NCT06590896 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are Japanese individuals who have previously participated in the related study YKP3089C035.
✕Probably not a fit
Patients who have previously discontinued from the core study or have significant medical history changes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the long-term safety and tolerability of cenobamate in Japanese patients suffering from partial onset seizures. Participants must have previously completed a related study and will be monitored for any adverse effects or changes in their medical condition. The study focuses on gathering data to ensure that cenobamate is a safe treatment option for this specific population.
Why it matters
Potential benefit: If successful, this study could provide a new, safe treatment option for Japanese patients with partial onset seizures.
How similar studies have gone: While this approach is focused on a specific population, similar studies evaluating the safety of new epilepsy treatments have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects completed Study YKP3089C035 by SK Life Science. Exclusion Criteria: * Subjects that have previously discontinued for any reason from the Core study (YKP3089C035). * Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.
Where it's running
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Ehime University Hospital
Ehime, Japan Recruiting -
Department of Neurology and Stroke Center, Southern Tohoku Clinic.
Fukushima, Japan Recruiting -
Hiroshima University Hospital
Hiroshima, Japan Recruiting -
NHO Kure Medical Center and Chugoku Cancer Center
Hiroshima, Japan Recruiting -
Asahikawa Medical University Hospital
Hokkaido, Japan Recruiting -
Itami City Hospital
Hyōgo, Japan Recruiting
Show 23 more locations
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JA-Ibaraki Tsuchiura Kyodo General Hospital
Ibaraki, Japan Recruiting -
University of Tsukuba Hospital
Ibaraki, Japan Recruiting -
Kagoshima University Hospital
Kagoshima, Japan Recruiting -
Tanaka Neurosurgical Clinic
Kagoshima, Japan Recruiting -
St. Marianna University School of Medicine Hospital
Kanagawa, Japan Recruiting -
Yokohama City University Hospital
Kanagawa, Japan Recruiting -
Kumamoto Ezuko Rehabilitation Medical Center
Kumamoto, Japan Recruiting -
NHO Nagasaki Medical Center
Nagasaki, Japan Recruiting -
Koide Clinic of Epilepsy and Neurological Disorders
Osaka, Japan Recruiting -
Osaka University Hospital
Osaka, Japan Recruiting -
Shintokukai Nii Neurosurgery and Psychiatry Clinic
Osaka, Japan Recruiting -
Ochiai Brain Clinic
Saitama, Japan Recruiting -
TMG ASAKA Medical Center
Saitama, Japan Recruiting -
Sakurai Clinic
Shiga, Japan Recruiting -
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Japan Recruiting -
Seirei Hamamatsu General Hospital
Shizuoka, Japan Recruiting -
Seirei Mikatahara General Hospital
Shizuoka, Japan Recruiting -
Jichi Medical University Hospital
Tochigi, Japan Recruiting -
Tokushima University Hospital
Tokushima, Japan Recruiting -
Medical Hospital, Tokyo Medical and Dental University
Tokyo, Japan Recruiting -
National Center of Neurology and Psychiatry
Tokyo, Japan Recruiting -
Tokyo Medical University Hospital
Tokyo, Japan Recruiting -
NHO Yamagata National Hospital
Yamagata, Japan Recruiting
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating zonisamide for treating focal epilepsy in children
This study is testing if adding zonisamide to the treatment of children aged 1-14 with hard-to-control focal epilepsy can help reduce their seizures and improve their thinking skills.
-
Advanced MRI techniques for detecting causes of focal epilepsy
This study is testing if advanced MRI techniques can help find hidden causes of focal epilepsy in patients who didn't show any problems on regular MRIs.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.