Tests cenobamate in Japanese people with generalized tonic-clonic seizures
Tests cenobamate added to other seizure medicines in Japanese people with epilepsy.
Plain-language title generated from the registry record
Registry title: ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Key facts
- Where
- Aichi, Fukuoka, Fukushima, Hiroshima, Hokkaido, Hyōgo, Ibaraki, Kagoshima, Kanagawa, Niigata, Osaka, Saitama, Shizuoka, Tochigi, Tokyo, Yamaguchi, and Yamanashi, JapanSee the 25 sites
- Phase
- Phase 3
Where in Japan
- Aichi Medical University HospitalAichi, JapanTaking people
- Hospital of the University of Occupational and Environmental Health, JapanFukuoka, JapanTaking people
- Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical ClinicFukushima, JapanTaking people
- Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens HospitalHiroshima, JapanTaking people
- Hokkaido University HospitalHokkaido, JapanTaking people
- Itami City HospitalHyōgo, JapanTaking people
- Tsuchiura Kyodo General HospitaIbaraki, JapanTaking people
- University of Tsukuba HospitalIbaraki, JapanTaking people
- Kagoshima University HospitalKagoshima, JapanTaking people
- SHOWA University Fujigaoka HospitalKanagawa, JapanTaking people
- Yokohama City University HospitalKanagawa, JapanTaking people
- National Hospital Organization Nishiniigata Chuo HospitalNiigata, JapanTaking people
- Koide Clinic of Epilepsy and Neurological DisordersOsaka, JapanTaking people
- TMG Asaka Medical CenterSaitama, JapanTaking people
- NHO Shizuoka Institute of Epilepsy and Neurological DisorderShizuoka, JapanTaking people
- Jichi Medical University HospitalTochigi, JapanTaking people
- Jikei University HospitalTokyo, JapanTaking people
- Maynds Tower Mental ClinicTokyo, JapanTaking people
- National Center of Neurology and PsychiatryTokyo, JapanTaking people
- Nihonbashi Neuro ClinicTokyo, JapanTaking people
- Shinjuku Neuro ClinicTokyo, JapanTaking people
- Tokyo Women's Medical University, Adachi Medical CenterTokyo, JapanTaking people
- Yamaguchi Grand Medical CenterYamaguchi, JapanTaking people
- University of Yamanashi HospitalYamanashi, JapanTaking people
- Yamanashi Prefectural Central HospitalYamanashi, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT06579573
- Record updated
- 17 June 2025
- Original description
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.Read full original descriptionShow less
ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Inclusion: Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent; Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy; Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks; Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens.
Exclusion: Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment; Subject has a concomitant diagnosis of Partial Onset Seizure(POS); Subject has seizure clusters where individual seizures cannot be counted orclassified; History of non-epileptic or psychogenic seizures; Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.