A Phase 3 interventional study of Cenobamate in Epilepsy, Generalized, sponsored by Ono Pharmaceutical Co. Ltd. Recruiting at 25 sites in Japan. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Ono Pharmaceutical Co. Ltd · Phase 3, Interventional, and Treatment
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.
This study's planned enrollment of 15 is below the median of 75 across 25 interventional studies indexed under Epilepsy, Generalized.
Browse Epilepsy, Generalized studies →Ono Pharmaceutical Co. Ltd is the lead sponsor of 63 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cenobamate
Cenobamate will be orally administered once daily.
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.
Time frame: 12 Weeks of the Maintenance Phase
Percentage Change in all generalized seizure frequency per 28-Day
Convert the frequency of all generalized seizures in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.
Time frame: 12 Weeks of the Maintenance Phase
Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval
The percentage of subjects who have a 50%, 75%, 90%, and 100% reduction in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to the Pre-treatment Phase
Time frame: 12 Weeks of the Maintenance Phase
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Jan 2027, 54 months after the start.
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Studies of the drug tested here: Cenobamate