ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Japan
Aichi Medical University Hospital
RECRUITING
Aichi
Hospital of the University of Occupational and Environmental Health, Japan
RECRUITING
Fukuoka
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
RECRUITING
Fukushima
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
RECRUITING
Hiroshima
Hokkaido University Hospital
RECRUITING
Hokkaido
Itami City Hospital
RECRUITING
Hyōgo
Tsuchiura Kyodo General Hospita
RECRUITING
Ibaraki
University of Tsukuba Hospital
RECRUITING
Ibaraki
Kagoshima University Hospital
RECRUITING
Kagoshima
SHOWA University Fujigaoka Hospital
RECRUITING
Kanagawa
Yokohama City University Hospital
RECRUITING
Kanagawa
National Hospital Organization Nishiniigata Chuo Hospital
RECRUITING
Niigata
Koide Clinic of Epilepsy and Neurological Disorders
RECRUITING
Osaka
TMG Asaka Medical Center
RECRUITING
Saitama
NHO Shizuoka Institute of Epilepsy and Neurological Disorder
RECRUITING
Shizuoka
Jichi Medical University Hospital
RECRUITING
Tochigi
Jikei University Hospital
RECRUITING
Tokyo
Maynds Tower Mental Clinic
RECRUITING
Tokyo
National Center of Neurology and Psychiatry
RECRUITING
Tokyo
Nihonbashi Neuro Clinic
RECRUITING
Tokyo
Shinjuku Neuro Clinic
RECRUITING
Tokyo
Tokyo Women's Medical University, Adachi Medical Center
RECRUITING
Tokyo
Yamaguchi Grand Medical Center
RECRUITING
Yamaguchi
University of Yamanashi Hospital
RECRUITING
Yamanashi
Yamanashi Prefectural Central Hospital
RECRUITING
Yamanashi
Contact Information
Primary
North America Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+18665877745(Toll-Free)
Backup
International Clinical Trial Support Desk
clinical_trial@ono-pharma.com
+17162141777(Standard)
Time Frame
Start Date: 2022-07-12
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 15
Treatments
Experimental: Cenobamate
Related Therapeutic Areas
Sponsors
Leads: Ono Pharmaceutical Co. Ltd