Actively Recruiting
ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures
Led by Ono Pharmaceutical Co., Ltd. · Updated on 2025-06-17
15
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ONO-2017 (cenobamate) combined with other antiepileptic drugs in Japanese patients who have primary generalized tonic-clonic seizures. This phase III, open-label study focuses on patients aged 12 years or older who experience frequent generalized seizures as part of idiopathic generalized epilepsy. Participants will take cenobamate orally once daily alongside one to three other fixed-dose antiepileptic medications. The study aims to observe changes in seizure frequency over a 12-week maintenance period while monitoring safety and tolerability. Throughout the study, researchers will track seizure frequency and reduction rates using 28-day intervals during the maintenance phase. Participants will be assessed regularly for seizure control and any side effects. The study will continue until January 2027, allowing for ongoing evaluation of treatment effects and safety.
CONDITIONS
Brief Title
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Japanese patients of any gender aged 12 years or older at the time of consent
- Clinical diagnosis of primary generalized tonic-clonic seizures within idiopathic generalized epilepsy
- Experiencing at least 5 primary generalized tonic-clonic seizures in the past 12 weeks
- Currently receiving 1 to 3 antiepileptic drugs at fixed doses
You will not qualify if you...
- History of status epilepticus requiring hospitalization within 15 months before enrollment
- Seizure clusters where individual seizures cannot be counted or classified
- History of non-epileptic or psychogenic seizures
- Diagnosis of partial onset seizures
- History of serious drug-induced hypersensitivity reactions or drug-related rash requiring hospitalization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive the study drug Cenobamate orally once daily as treatment for their seizures.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 25 locations
1
Aichi Medical University Hospital
Aichi, Japan
Actively Recruiting
2
Hospital of the University of Occupational and Environmental Health, Japan
Fukuoka, Japan
Actively Recruiting
3
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Fukushima, Japan
Actively Recruiting
4
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Actively Recruiting
5
Hokkaido University Hospital
Hokkaido, Japan
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6
Itami City Hospital
Hyōgo, Japan
Actively Recruiting
7
Tsuchiura Kyodo General Hospita
Ibaraki, Japan
Actively Recruiting
8
University of Tsukuba Hospital
Ibaraki, Japan
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9
Kagoshima University Hospital
Kagoshima, Japan
Actively Recruiting
10
SHOWA University Fujigaoka Hospital
Kanagawa, Japan
Actively Recruiting
11
Yokohama City University Hospital
Kanagawa, Japan
Actively Recruiting
12
National Hospital Organization Nishiniigata Chuo Hospital
Niigata, Japan
Actively Recruiting
13
Koide Clinic of Epilepsy and Neurological Disorders
Osaka, Japan
Actively Recruiting
14
TMG Asaka Medical Center
Saitama, Japan
Actively Recruiting
15
NHO Shizuoka Institute of Epilepsy and Neurological Disorder
Shizuoka, Japan
Actively Recruiting
16
Jichi Medical University Hospital
Tochigi, Japan
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17
Jikei University Hospital
Tokyo, Japan
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18
Maynds Tower Mental Clinic
Tokyo, Japan
Actively Recruiting
19
National Center of Neurology and Psychiatry
Tokyo, Japan
Actively Recruiting
20
Nihonbashi Neuro Clinic
Tokyo, Japan
Actively Recruiting
21
Shinjuku Neuro Clinic
Tokyo, Japan
Actively Recruiting
22
Tokyo Women's Medical University, Adachi Medical Center
Tokyo, Japan
Actively Recruiting
23
Yamaguchi Grand Medical Center
Yamaguchi, Japan
Actively Recruiting
24
University of Yamanashi Hospital
Yamanashi, Japan
Actively Recruiting
25
Yamanashi Prefectural Central Hospital
Yamanashi, Japan
Actively Recruiting
Research Team
N
North America Clinical Trial Support Desk
I
International Clinical Trial Support Desk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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