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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for Japanese people aged 12 or older with primary generalized tonic-clonic seizures caused by idiopathic generalized epilepsy. They must already take 1 to 3 seizure medicines.
- Age
- 12 years or older
- Sex
- All sexes can join
- Disease stage
- Primary generalized tonic-clonic seizures with idiopathic generalized epilepsy, at least 5 seizures in 12 weeks
- Earlier treatment
- Must be taking 1 to a maximum of 3 antiepileptic drugs at fixed doses
Main reasons for not taking part
- Status epilepticus needing hospital stay within 15 months before enrollment
- Seizure clusters where single seizures cannot be counted or classified
- History of non-epileptic or psychogenic seizures
- Partial onset seizures at the same time
- Serious drug-induced hypersensitivity reaction, or drug rash needing hospital care
Read by machine on 12 November 2026.
Where in Japan
- Aichi Medical University HospitalAichi, JapanContact: North America Clinical Trial Support DeskTaking people
- Hospital of the University of Occupational and Environmental Health, JapanFukuoka, JapanContact: North America Clinical Trial Support DeskTaking people
- Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical ClinicFukushima, JapanContact: North America Clinical Trial Support DeskTaking people
- Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens HospitalHiroshima, JapanContact: North America Clinical Trial Support DeskTaking people
- Hokkaido University HospitalHokkaido, JapanContact: North America Clinical Trial Support DeskTaking people
- Itami City HospitalHyōgo, JapanContact: North America Clinical Trial Support DeskTaking people
- Tsuchiura Kyodo General HospitaIbaraki, JapanContact: North America Clinical Trial Support DeskTaking people
- University of Tsukuba HospitalIbaraki, JapanContact: North America Clinical Trial Support DeskTaking people
- Kagoshima University HospitalKagoshima, JapanContact: North America Clinical Trial Support DeskTaking people
- SHOWA University Fujigaoka HospitalKanagawa, JapanContact: North America Clinical Trial Support DeskTaking people
- Yokohama City University HospitalKanagawa, JapanContact: North America Clinical Trial Support DeskTaking people
- National Hospital Organization Nishiniigata Chuo HospitalNiigata, JapanContact: North America Clinical Trial Support DeskTaking people
- Koide Clinic of Epilepsy and Neurological DisordersOsaka, JapanContact: North America Clinical Trial Support DeskTaking people
- TMG Asaka Medical CenterSaitama, JapanContact: North America Clinical Trial Support DeskTaking people
- NHO Shizuoka Institute of Epilepsy and Neurological DisorderShizuoka, JapanContact: North America Clinical Trial Support DeskTaking people
- Jichi Medical University HospitalTochigi, JapanContact: North America Clinical Trial Support DeskTaking people
- Jikei University HospitalTokyo, JapanContact: North America Clinical Trial Support DeskTaking people
- Maynds Tower Mental ClinicTokyo, JapanContact: North America Clinical Trial Support DeskTaking people
- National Center of Neurology and PsychiatryTokyo, JapanContact: North America Clinical Trial Support DeskTaking people
- Nihonbashi Neuro ClinicTokyo, JapanContact: North America Clinical Trial Support DeskTaking people
- Shinjuku Neuro ClinicTokyo, JapanContact: North America Clinical Trial Support DeskTaking people
- Tokyo Women's Medical University, Adachi Medical CenterTokyo, JapanContact: North America Clinical Trial Support DeskTaking people
- Yamaguchi Grand Medical CenterYamaguchi, JapanContact: North America Clinical Trial Support DeskTaking people
- University of Yamanashi HospitalYamanashi, JapanContact: North America Clinical Trial Support DeskTaking people
- Yamanashi Prefectural Central HospitalYamanashi, JapanContact: North America Clinical Trial Support DeskTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.