ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Recruiting · NCT06579573 · Interventional (participants receive a specific treatment) · Lead sponsor: Ono Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Who can take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
- Subject has seizure clusters where individual seizures cannot be counted orclassified.
- History of non-epileptic or psychogenic seizures.
- Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
- 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.
Where it is running
25 locations listed.
- Aichi Medical University Hospital - Aichi, Japan
- Hospital of the University of Occupational and Environmental Health, Japan - Fukuoka, Japan
- Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic - Fukushima, Japan
- Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital - Hiroshima, Japan
- Hokkaido University Hospital - Hokkaido, Japan
- Itami City Hospital - Hyōgo, Japan
- Tsuchiura Kyodo General Hospita - Ibaraki, Japan
- University of Tsukuba Hospital - Ibaraki, Japan
- Kagoshima University Hospital - Kagoshima, Japan
- SHOWA University Fujigaoka Hospital - Kanagawa, Japan
- Yokohama City University Hospital - Kanagawa, Japan
- National Hospital Organization Nishiniigata Chuo Hospital - Niigata, Japan
- Koide Clinic of Epilepsy and Neurological Disorders - Osaka, Japan
- TMG Asaka Medical Center - Saitama, Japan
- NHO Shizuoka Institute of Epilepsy and Neurological Disorder - Shizuoka, Japan
- Jichi Medical University Hospital - Tochigi, Japan
- Jikei University Hospital - Tokyo, Japan
- Maynds Tower Mental Clinic - Tokyo, Japan
- National Center of Neurology and Psychiatry - Tokyo, Japan
- Nihonbashi Neuro Clinic - Tokyo, Japan
- Shinjuku Neuro Clinic - Tokyo, Japan
- Tokyo Women's Medical University, Adachi Medical Center - Tokyo, Japan
- Yamaguchi Grand Medical Center - Yamaguchi, Japan
- University of Yamanashi Hospital - Yamanashi, Japan
- Yamanashi Prefectural Central Hospital - Yamanashi, Japan