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.
2 other identifiers
interventional
15
1 country
25
Brief Summary
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2022
Longer than P75 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2022
CompletedFirst Submitted
Initial submission to the registry
August 8, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
June 17, 2025
June 1, 2025
4.6 years
August 8, 2024
June 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval
Convert the frequency of generalized tonic-clonic seizures (PGTC) in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.
12 Weeks of the Maintenance Phase
Secondary Outcomes (2)
Percentage Change in all generalized seizure frequency per 28-Day
12 Weeks of the Maintenance Phase
Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval
12 Weeks of the Maintenance Phase
Study Arms (1)
Cenobamate
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Central Study Contacts
North America Clinical Trial Support Desk
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2024
First Posted
August 30, 2024
Study Start
July 12, 2022
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share