Evaluating the safety of cenobamate for Japanese patients with partial seizures
A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
PHASE2 · Ono Pharmaceutical Co., Ltd. · NCT06590896
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. (industry) |
| Locations | 29 sites (Ehime and 28 other locations) |
| Trial ID | NCT06590896 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese individuals who have previously participated in the related study YKP3089C035.
Not a fit: Patients who have previously discontinued from the core study or have significant medical history changes may not benefit from this study.
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 performed: While this approach is focused on a specific population, similar studies evaluating the safety of new epilepsy treatments have shown promising results.
Eligibility criteria
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 this trial is running
Ehime and 28 other locations
- 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)
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsies, Partial