ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Recruiting now · Phase 3

Conditions studied: Epilepsy, Generalized

In brief

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

Key facts

Study ID

NCT06579573

Run by

Ono Pharmaceutical Co., Ltd.

People needed

15

Starts

2022-07-12

Expected to finish

2027-01-31

Last updated by the study team

2025-06-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Aichi Medical University Hospital — Aichi, Japan (enrolling)
• Hospital of the University of Occupational and Environmental Health, Japan — Fukuoka, Japan (enrolling)
• Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic — Fukushima, Japan (enrolling)
• Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital — Hiroshima, Japan (enrolling)
• Hokkaido University Hospital — Hokkaido, Japan (enrolling)
• Itami City Hospital — Hyōgo, Japan (enrolling)
• Tsuchiura Kyodo General Hospita — Ibaraki, Japan (enrolling)
• University of Tsukuba Hospital — Ibaraki, Japan (enrolling)
• Kagoshima University Hospital — Kagoshima, Japan (enrolling)
• SHOWA University Fujigaoka Hospital — Kanagawa, Japan (enrolling)
• Yokohama City University Hospital — Kanagawa, Japan (enrolling)
• National Hospital Organization Nishiniigata Chuo Hospital — Niigata, Japan (enrolling)
• Koide Clinic of Epilepsy and Neurological Disorders — Osaka, Japan (enrolling)
• TMG Asaka Medical Center — Saitama, Japan (enrolling)
• NHO Shizuoka Institute of Epilepsy and Neurological Disorder — Shizuoka, Japan (enrolling)
• Jichi Medical University Hospital — Tochigi, Japan (enrolling)
• Jikei University Hospital — Tokyo, Japan (enrolling)
• Maynds Tower Mental Clinic — Tokyo, Japan (enrolling)
• National Center of Neurology and Psychiatry — Tokyo, Japan (enrolling)
• Nihonbashi Neuro Clinic — Tokyo, Japan (enrolling)
• Shinjuku Neuro Clinic — Tokyo, Japan (enrolling)
• Tokyo Women's Medical University, Adachi Medical Center — Tokyo, Japan (enrolling)
• Yamaguchi Grand Medical Center — Yamaguchi, Japan (enrolling)
• University of Yamanashi Hospital — Yamanashi, Japan (enrolling)
• Yamanashi Prefectural Central Hospital — Yamanashi, Japan (enrolling)

Full record on ClinicalTrials.gov

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