NCT06579573RecruitingPhase 3
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Source: ClinicalTrials.gov · Last updated 17 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 8 Aug 2024
- Start date
- 12 Jul 2022
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Epilepsy
- NCT number
- NCT06579573
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 15
- From 12 Jul 2022 to the primary completion date, 31 Jan 2027
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aichi Medical University Hospital Coordinator of this site? Confirm its status | Aichi | Japan | Recruiting |
| Hospital of the University of Occupational and Environmental Health, Japan Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic Coordinator of this site? Confirm its status | Fukushima | Japan | Recruiting |
| Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Recruiting |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Hokkaido | Japan | Recruiting |
| Itami City Hospital Coordinator of this site? Confirm its status | Hyōgo | Japan | Recruiting |
| Tsuchiura Kyodo General Hospita Coordinator of this site? Confirm its status | Ibaraki | Japan | Recruiting |
| University of Tsukuba Hospital Coordinator of this site? Confirm its status | Ibaraki | Japan | Recruiting |
| Kagoshima University Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Yokohama City University Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Recruiting |
| SHOWA University Fujigaoka Hospital Coordinator of this site? Confirm its status | Kanagawa | Japan | Recruiting |
| National Hospital Organization Nishiniigata Chuo Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| Koide Clinic of Epilepsy and Neurological Disorders Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| TMG Asaka Medical Center Coordinator of this site? Confirm its status | Saitama | Japan | Recruiting |
| NHO Shizuoka Institute of Epilepsy and Neurological Disorder Coordinator of this site? Confirm its status | Shizuoka | Japan | Recruiting |
| Jichi Medical University Hospital Coordinator of this site? Confirm its status | Tochigi | Japan | Recruiting |
| National Center of Neurology and Psychiatry Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Jikei University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Nihonbashi Neuro Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tokyo Women's Medical University, Adachi Medical Center Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Shinjuku Neuro Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Maynds Tower Mental Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Yamaguchi Grand Medical Center Coordinator of this site? Confirm its status | Yamaguchi | Japan | Recruiting |
| University of Yamanashi Hospital Coordinator of this site? Confirm its status | Yamanashi | Japan | Recruiting |
| Yamanashi Prefectural Central Hospital Coordinator of this site? Confirm its status | Yamanashi | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.