Partial EpilepsyPhase 3NCT07594158
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
A Phase 3 study testing Cenobamate (tablet) for 12 to < 18 year olds and Cenobamate (syrup) for 2 to < 18 year olds in people with Partial Epilepsy, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- Cenobamate (tablet) for 12 to < 18 year olds and Cenobamate (syrup) for 2 to < 18 year olds
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- 10 Jun 2026to 31 Dec 2029
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
- Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
- Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
- Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.
Who cannot join
- Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
- Patients with a history of non-epileptic psychogenic seizures.
- Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
- Patients diagnosed with Lennox-Gastaut syndrome.
- Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome [DIHS]) or drug-induced rash requiring hospitalization.
Trial locations and contacts
1 site 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
About this study
Official title: A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Read the detailed description
Secondary objectives:
To evaluate the efficacy of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset (focal) seizures
To evaluate the pharmacokinetics of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset seizures
- Conditions
- Partial Epilepsy
- Being tested
- Cenobamate (tablet) for 12 to < 18 year olds, Cenobamate (syrup) for 2 to < 18 year olds
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenobamate (tablet) for 12 to < 18 year oldsDrug
The tablet form of ONO-2017 will be initiated at a dose of 12.5 mg once daily and titrated in the specified method to a target dose of 200 mg per day. The daily dose may be increased/reduced as appropriate according to symptoms within the range not exceeding 400 mg. In addition, depending on clinical response and tolerability, dose titration may be stopped at a dose of ≥ 50 mg per day to establish the maintenance dose. In principle, all doses should be taken with an appropriate amount of water in the morning. The dosage form for the doses will be selected by the principal investigator or designee. ONO-2017 can be treated until ONO-2017 is market approved, enters the market, and becomes available for supply to the study site.
Cenobamate (syrup) for 2 to < 18 year oldsDrug
The syrup form of ONO-2017 will be administered at a dose equivalent to that for 12-18 year olds on a body weight basis
| Study group | Role | What they receive |
|---|---|---|
| 2 to < 18 year olds | Experimental | Not described Receives: Drug: Cenobamate (tablet) for 12 to < 18 year olds; Drug: Cenobamate (syrup) for 2 to < 18 year olds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and adverse drug reactions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start10 Jun 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EpilepsyStudies 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
- 20 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 PharmaceuticalCo., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594158
- Sponsor's protocol ID
- ONO-2017-04
- Other IDs
- jRCT207126002
- Status last verified
- Oct 2026
- First submitted
- 11 May 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.
- ClinicalTrials.gov ID
- NCT07594158
- Acronym / sponsor ID
- ONO-2017-04
- Conditions
- Partial Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 May 2026 (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.
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Detailed description
Secondary objectives:
To evaluate the efficacy of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset (focal) seizures
To evaluate the pharmacokinetics of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset seizures
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 to < 18 year olds | Experimental | Drug: Cenobamate (tablet) for 12 to < 18 year olds, Drug: Cenobamate (syrup) for 2 to < 18 year olds |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
- Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
- Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
- Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.
Key exclusion criteria (5 listed)
- Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
- Patients with a history of non-epileptic psychogenic seizures.
- Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
- Patients diagnosed with Lennox-Gastaut syndrome.
- Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome [DIHS]) or drug-induced 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 |
|---|---|---|
| Cenobamate (tablet) for 12 to < 18 year oldsThe tablet form of ONO-2017 will be initiated at a dose of 12.5 mg once daily and titrated in the specified method to a target dose of 200 mg per day. The daily dose may be increased/reduced as appropriate according to symptoms within the range not exceeding 400 mg. In addition, depending on clinical response and tolerability, dose titration may be stopped at a dose of ≥ 50 mg per day to establish the maintenance dose. In principle, all doses should be taken with an appropriate amount of water in the morning. The dosage form for the doses will be selected by the principal investigator or designee. ONO-2017 can be treated until ONO-2017 is market approved, enters the market, and becomes available for supply to the study site. | Drug | 2 to < 18 year olds |
| Cenobamate (syrup) for 2 to < 18 year oldsThe syrup form of ONO-2017 will be administered at a dose equivalent to that for 12-18 year olds on a body weight basis | Drug | 2 to < 18 year olds |
Primary outcome
Adverse events and adverse drug reactions
Time frame: 1 year
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 9 Oct 2026.
- 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 PharmaceuticalCo., Ltd.
1 site 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 (tablet) for 12 to < 18 year olds and Cenobamate (syrup) for 2 to < 18 year olds in people with Partial Epilepsy, run by Ono Pharmaceutical Co., Ltd. at 1 site 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Adverse events and adverse drug reactions (time frame: 1 year). 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 9 Oct 2026.