Epilepsy, GeneralizedPhase 3NCT06579573
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
A Phase 3 study testing Cenobamate in people with Epilepsy, Generalized, run by Ono Pharmaceutical Co., Ltd. at 25 sites in Japan.
Trial summary
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Epilepsy, Generalized
- What is being tested?
- Cenobamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 25 sitesJapan
- Study dates
- 12 Jul 2022to 31 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
25 sites in 1 country
Japan25 sites, 25 recruiting
- Recruiting
Aichi Medical University Hospital
Aichi
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan
Fukuoka
- Recruiting
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Fukushima
- Recruiting
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima
- Recruiting
Hokkaido University Hospital
Hokkaido
- Recruiting
Itami City Hospital
Hyōgo
- Recruiting
Tsuchiura Kyodo General Hospita
Ibaraki
- Recruiting
University of Tsukuba Hospital
Ibaraki
- Recruiting
Kagoshima University Hospital
Kagoshima
- Recruiting
SHOWA University Fujigaoka Hospital
Kanagawa
- Recruiting
Yokohama City University Hospital
Kanagawa
- Recruiting
National Hospital Organization Nishiniigata Chuo Hospital
Niigata
- Recruiting
Koide Clinic of Epilepsy and Neurological Disorders
Osaka
- Recruiting
TMG Asaka Medical Center
Saitama
- Recruiting
NHO Shizuoka Institute of Epilepsy and Neurological Disorder
Shizuoka
- Recruiting
Jichi Medical University Hospital
Tochigi
- Recruiting
Jikei University Hospital
Tokyo
- Recruiting
Maynds Tower Mental Clinic
Tokyo
- Recruiting
National Center of Neurology and Psychiatry
Tokyo
- Recruiting
Nihonbashi Neuro Clinic
Tokyo
- Recruiting
Shinjuku Neuro Clinic
Tokyo
- Recruiting
Tokyo Women's Medical University, Adachi Medical Center
Tokyo
- Recruiting
Yamaguchi Grand Medical Center
Yamaguchi
- Recruiting
University of Yamanashi Hospital
Yamanashi
- Recruiting
Yamanashi Prefectural Central Hospital
Yamanashi
About this study
Official title: ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
- Conditions
- Epilepsy, Generalized
- Being tested
- Cenobamate
- Medical subject headings
- Epilepsy, Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenobamateDrug
Cenobamate will be orally administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| Cenobamate | Experimental | Not described Receives: Drug: Cenobamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks of the Maintenance Phase
Secondary outcomes (2)
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.
Measured: 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
Measured: 12 Weeks of the Maintenance Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start12 Jul 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, GeneralizedStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579573
- Sponsor's protocol ID
- ONO-2017-01
- Other IDs
- jRCT2031210624
- Status last verified
- Jun 2025
- First submitted
- 8 Aug 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
- ClinicalTrials.gov ID
- NCT06579573
- Acronym / sponsor ID
- ONO-2017-01
- Conditions
- Epilepsy, Generalized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cenobamate | Experimental | Drug: Cenobamate |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenobamateCenobamate will be orally administered once daily. | Drug | Cenobamate |
Primary outcome
Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval
Time frame: 12 Weeks of the Maintenance Phase
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.
2 secondary outcomes
Percentage Change in all generalized seizure frequency per 28-Day
Time frame: 12 Weeks of the Maintenance Phase
Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval
Time frame: 12 Weeks of the Maintenance Phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
North America Clinical Trial Support Desk contact
International Clinical Trial Support Desk contact
Project Leader study director
Ono Pharmaceutical Co., Ltd.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cenobamate in people with Epilepsy, Generalized, run by Ono Pharmaceutical Co., Ltd. at 25 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact North America Clinical Trial Support Desk (+18665877745(Toll-Free), clinical_trial@ono-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval (time frame: 12 Weeks of the Maintenance Phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.