RecruitingPhase 3NCT06579573

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.

Sponsor

Ono Pharmaceutical Co. Ltd

Enrollment

15 participants

Start Date

Jul 12, 2022

Study Type

INTERVENTIONAL

Conditions

Epilepsy, Generalized

Summary

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Eligibility

Min Age: 12 Years

Inclusion Criteria4

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 Criteria5

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.

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Interventions

DRUGCenobamate

Cenobamate will be orally administered once daily.

Locations(25)

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

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