Clinical Trials in Japan / NCT06579573
Recruiting
Phase 3
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
NCT06579573 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Epilepsy, Generalized
Investigational drug(s) / intervention(s)
Cenobamate: Cenobamate will be orally administered once daily.
Study summary
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Eligibility
Inclusion Criteria:
1. Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.
2. Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
3. Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
4. Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens
Exclusion Criteria:
1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
2. Subject has seizure clusters where individual seizures cannot be counted orclassified.
3. History of non-epileptic or psychogenic seizures.
4. Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
5. 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.
Primary outcome measure(s)
- Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval — 12 Weeks of the Maintenance Phase
Convert the frequency of generalized tonic-clonic seizures (PGTC) in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| Aichi Medical University Hospital | Aichi | Japan | Recruiting |
| Hospital of the University of Occupational and Environmental Health, Japan | Fukuoka | Japan | Recruiting |
| Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic | Fukushima | Japan | Recruiting |
| Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Japan | Recruiting |
| Hokkaido University Hospital | Hokkaido | Japan | Recruiting |
| Itami City Hospital | Hyōgo | Japan | Recruiting |
| Tsuchiura Kyodo General Hospita | Ibaraki | Japan | Recruiting |
| University of Tsukuba Hospital | Ibaraki | Japan | Recruiting |
| Kagoshima University Hospital | Kagoshima | Japan | Recruiting |
| SHOWA University Fujigaoka Hospital | Kanagawa | Japan | Recruiting |
| Yokohama City University Hospital | Kanagawa | Japan | Recruiting |
| National Hospital Organization Nishiniigata Chuo Hospital | Niigata | Japan | Recruiting |
| Koide Clinic of Epilepsy and Neurological Disorders | Osaka | Japan | Recruiting |
| TMG Asaka Medical Center | Saitama | Japan | Recruiting |
| NHO Shizuoka Institute of Epilepsy and Neurological Disorder | Shizuoka | Japan | Recruiting |
| Jichi Medical University Hospital | Tochigi | Japan | Recruiting |
| Jikei University Hospital | Tokyo | Japan | Recruiting |
| Maynds Tower Mental Clinic | Tokyo | Japan | Recruiting |
| National Center of Neurology and Psychiatry | Tokyo | Japan | Recruiting |
| Nihonbashi Neuro Clinic | Tokyo | Japan | Recruiting |
| Shinjuku Neuro Clinic | Tokyo | Japan | Recruiting |
| Tokyo Women's Medical University, Adachi Medical Center | Tokyo | Japan | Recruiting |
| Yamaguchi Grand Medical Center | Yamaguchi | Japan | Recruiting |
| University of Yamanashi Hospital | Yamanashi | Japan | Recruiting |
| Yamanashi Prefectural Central Hospital | Yamanashi | Japan | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06579573 on ClinicalTrials.gov ↗ ← All trials in Japan