Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
Launched by ONO PHARMACEUTICAL CO. LTD · Sep 8, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the long-term safety and tolerability of a medication called cenobamate in Japanese patients who experience partial onset seizures, a type of epilepsy. The trial is currently recruiting participants, and it aims to gather information on how well cenobamate can be tolerated over time in people who have already taken part in a previous study.
To be eligible for this trial, participants must have completed an earlier study (referred to as YKP3089C035) and cannot have stopped participating in that study for any reason. Additionally, if there have been significant changes to their health since that study, they may not be allowed to join. Those who participate can expect regular check-ins to monitor their health and how they respond to the medication. Overall, this trial is important because it seeks to ensure that cenobamate is safe for long-term use in individuals with partial seizures.
Gender
ALL
Eligibility 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.
About Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co., Ltd. is a leading Japanese biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies that address unmet medical needs. With a strong focus on oncology, immunology, and central nervous system disorders, Ono leverages cutting-edge technology and scientific expertise to advance its pipeline of novel treatments. Committed to enhancing patient outcomes, Ono collaborates with global partners and invests in clinical trials to bring transformative medicines to market, exemplifying its mission to improve health and quality of life worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hiroshima, , Japan
Hiroshima, , Japan
Tokyo, , Japan
Tochigi, , Japan
Kagoshima, , Japan
Tokyo, , Japan
Tokushima, , Japan
Osaka, , Japan
Nagasaki, , Japan
Ibaraki, , Japan
Shizuoka, , Japan
Kanagawa, , Japan
Ehime, , Japan
Hyōgo, , Japan
Osaka, , Japan
Saitama, , Japan
Fukushima, , Japan
Hiroshima, , Japan
Hokkaido, , Japan
Ibaraki, , Japan
Kagoshima, , Japan
Kanagawa, , Japan
Kumamoto, , Japan
Osaka, , Japan
Saitama, , Japan
Shiga, , Japan
Shizuoka, , Japan
Shizuoka, , Japan
Tokyo, , Japan
Yamagata, , Japan
Patients applied
Trial Officials
Project Leader
Study Director
Ono Pharmaceutical Co. Ltd
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported