Epilepsies, PartialPhase 2NCT06590896
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
A Phase 2 study testing Cenobamate in people with Epilepsies, Partial, run by Ono Pharmaceutical Co., Ltd. at 29 sites in Japan.
Trial summary
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsies, Partial
- 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
- 100 participants
- Where
- 29 sitesJapan
- Study dates
- 4 Nov 2022to 31 Jan 2027
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects completed Study YKP3089C035 by SK Life Science.
Who cannot join
- Subjects that have previously discontinued for any reason from the Core study (YKP3089C035).
- Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.
Trial locations and contacts
29 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
29 sites in 1 country
Japan29 sites, 29 recruiting
- Recruiting
Ehime University Hospital
Ehime
- Recruiting
Department of Neurology and Stroke Center, Southern Tohoku Clinic.
Fukushima
- Recruiting
Hiroshima University Hospital
Hiroshima
- Recruiting
NHO Kure Medical Center and Chugoku Cancer Center
Hiroshima
- Recruiting
Asahikawa Medical University Hospital
Hokkaido
- Recruiting
Itami City Hospital
Hyōgo
- Recruiting
JA-Ibaraki Tsuchiura Kyodo General Hospital
Ibaraki
- Recruiting
University of Tsukuba Hospital
Ibaraki
- Recruiting
Kagoshima University Hospital
Kagoshima
- Recruiting
Tanaka Neurosurgical Clinic
Kagoshima
- Recruiting
St. Marianna University School of Medicine Hospital
Kanagawa
- Recruiting
Yokohama City University Hospital
Kanagawa
- Recruiting
Kumamoto Ezuko Rehabilitation Medical Center
Kumamoto
- Recruiting
NHO Nagasaki Medical Center
Nagasaki
- Recruiting
Koide Clinic of Epilepsy and Neurological Disorders
Osaka
- Recruiting
Osaka University Hospital
Osaka
- Recruiting
Shintokukai Nii Neurosurgery and Psychiatry Clinic
Osaka
- Recruiting
Ochiai Brain Clinic
Saitama
- Recruiting
TMG ASAKA Medical Center
Saitama
- Recruiting
Sakurai Clinic
Shiga
- Recruiting
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka
- Recruiting
Seirei Hamamatsu General Hospital
Shizuoka
- Recruiting
Seirei Mikatahara General Hospital
Shizuoka
- Recruiting
Jichi Medical University Hospital
Tochigi
- Recruiting
Tokushima University Hospital
Tokushima
- Recruiting
Medical Hospital, Tokyo Medical and Dental University
Tokyo
- Recruiting
National Center of Neurology and Psychiatry
Tokyo
- Recruiting
Tokyo Medical University Hospital
Tokyo
- Recruiting
NHO Yamagata National Hospital
Yamagata
About this study
Official title: A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
- Conditions
- Epilepsies, Partial
- Being tested
- Cenobamate
- Medical subject headings
- Epilepsies, Partial
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.
Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.
Measured: Through study completion, an average of 4 years
Urinalysis(pH)
Measurement of urine pH.
Measured: Through study completion, an average of 4 years
Urinalysis(Specific Gravity)
Measurement of urine specific gravity (g/mL).
Measured: Through study completion, an average of 4 years
Urinalysis(Protein)
Measurement of urine protein (mg/dL).
Measured: Through study completion, an average of 4 years
Urinalysis(Glucose)
Measurement of urine glucose (mg/dL).
Measured: Through study completion, an average of 4 years
Urinalysis(Ketone)
Measurement of urine ketone (mg/dL).
Measured: Through study completion, an average of 4 years
Urinalysis(Bilirubin)
Measurement of urine bilirubin (mg/dL).
Measured: Through study completion, an average of 4 years
Urinalysis(Blood)
Measurement of urine blood (presence/absence).
Measured: Through study completion, an average of 4 years
Urinalysis(Nitrite)
Measurement of urine nitrite (presence/absence).
Measured: Through study completion, an average of 4 years
Urinalysis(Urobilinogen)
Measurement of urine urobilinogen (mg/dL).
Measured: Through study completion, an average of 4 years
Urinalysis( Microscopic Examination)
Microscopic examination of urine (if abnormal).
Measured: Through study completion, an average of 4 years
Liver function tests(total protein)
Measurement of total protein(g/dL)
Measured: Through study completion, an average of 4 years
Liver function tests(albumin)
Measurement of albumin(g/dL)
Measured: Through study completion, an average of 4 years
Liver function tests(total bilirubin)
Measurement of total bilirubin(mg/dL)
Measured: Through study completion, an average of 4 years
Liver function tests(aspartate transaminase)
Measurement of aspartate transaminase(U/L)
Measured: Through study completion, an average of 4 years
Liver function tests(alanine aminotransferase)
Measurement of alanine aminotransferase(U/L)
Measured: Through study completion, an average of 4 years
Liver function tests(alkaline phosphatase)
alkaline phosphatase(U/L)
Measured: Through study completion, an average of 4 years
Liver function tests(gamma-glutamyl transferase)
Measurement of gamma-glutamyl transferase(U/L)
Measured: Through study completion, an average of 4 years
Hematology(Hemoglobin)
Measurement of hemoglobin(g/dL)
Measured: Through study completion, an average of 4 years
Hematology(hematocrit)
Measurement of hematocrit(%)
Measured: Through study completion, an average of 4 years
Hematology(white blood cell count)
Measurement of white blood cell count（/μL）
Measured: Through study completion, an average of 4 years
Hematology(red blood cell count)
Measurement of red blood cell count（/μL)
Measured: Through study completion, an average of 4 years
Hematology(mean corpuscular volume)
Measurement of mean corpuscular volume(fL)
Measured: Through study completion, an average of 4 years
Hematology(mean corpuscular hemoglobin)
Measurement of mean corpuscular hemoglobin(pg)
Measured: Through study completion, an average of 4 years
Hematology(red blood cell distribution width)
Measurement of red blood cell distribution width(％)
Measured: Through study completion, an average of 4 years
Hematology(platelet count)
Measurement of platelet count(/μL)
Measured: Through study completion, an average of 4 years
Serum chemistry(blood urea nitrogen)
Measurement of blood urea nitrogen(mg/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(calcium)
Measurement of calcium(mg/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(chloride)
Measurement of chloride(mEq/L)
Measured: Through study completion, an average of 4 years
Serum chemistry(creatinine)
Measurement of creatinine(mg/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(total bilirubin)
Measurement of total bilirubin(mg/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(direct bilirubin)
Measurement of direct bilirubin(mg/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(alkaline phosphatase)
Measurement of alkaline phosphatas（U/L）
Measured: Through study completion, an average of 4 years
Serum chemistry(alanine aminotransferase)
Measurement of alanine aminotransferase(U/L)
Measured: Through study completion, an average of 4 years
Serum chemistry(gamma-glutamyl transferase)
Measurement of gamma-glutamyl transferase(U/L)
Measured: Through study completion, an average of 4 years
Serum chemistry(total protein)
Measurement of total protein(g/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(albumin)
Measurement of albumin(g/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(globulin)
Measurement of globulin(g/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(sodium)
Measurement of sodium(mEq/L)
Measured: Through study completion, an average of 4 years
Serum chemistry(potassium)
Measurement of potassium(mEq/L)
Measured: Through study completion, an average of 4 years
Serum chemistry(phosphorus)
Measurement of phosphorus(mq/dL)
Measured: Through study completion, an average of 4 years
Serum chemistry(glucose)
Measurement of glucose(mq/dL)
Measured: Through study completion, an average of 4 years
Heart rate
heart rate (beats per minute)
Measured: Through study completion, an average of 4 years
Respiratory Rate
Respiratory Rate (breaths per minute),
Measured: Through study completion, an average of 4 years
Blood Pressure
blood pressure, both of systolic and diastolic (mm Hg)
Measured: Through study completion, an average of 4 years
Electrocardiogram (ECG) Findings
ECG findings, including heart rate (beats per minute), PR Interval (milliseconds), PQ Interval (milliseconds), RR Interval (milliseconds), QRS Interval (milliseconds), and QT Interval (milliseconds), will be recorded.
Measured: Through study completion, an average of 4 years
Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) will be recorded. Questions regarding suicide are recorded as yes or no, and the percentage of subject with suicide risk (yes) is assessed.
Measured: Through study completion, an average of 4 years
Secondary outcomes (1)
Percentage Change in all partial seizure frequency per 28-Day
It will confirm the frequency of partial seizures at 28-day intervals and calculate the percentage change until the study is completed.
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Nov 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 Epilepsies, PartialStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT06590896
- Sponsor's protocol ID
- ONO-2017-02
- Other IDs
- jRCT2031220198
- Status last verified
- Jun 2025
- First submitted
- 8 Aug 2024
- Last updated
- 3 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
- ClinicalTrials.gov ID
- NCT06590896
- Acronym / sponsor ID
- ONO-2017-02
- Conditions
- Epilepsies, Partial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Sep 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 evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial 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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects completed Study YKP3089C035 by SK Life Science.
Key exclusion criteria (2 listed)
- Subjects that have previously discontinued for any reason from the Core study (YKP3089C035).
- Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.
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
Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of 4 years
The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.
Urinalysis(pH)
Time frame: Through study completion, an average of 4 years
Measurement of urine pH.
Urinalysis(Specific Gravity)
Time frame: Through study completion, an average of 4 years
Measurement of urine specific gravity (g/mL).
Urinalysis(Protein)
Time frame: Through study completion, an average of 4 years
Measurement of urine protein (mg/dL).
Urinalysis(Glucose)
Time frame: Through study completion, an average of 4 years
Measurement of urine glucose (mg/dL).
Urinalysis(Ketone)
Time frame: Through study completion, an average of 4 years
Measurement of urine ketone (mg/dL).
Urinalysis(Bilirubin)
Time frame: Through study completion, an average of 4 years
Measurement of urine bilirubin (mg/dL).
Urinalysis(Blood)
Time frame: Through study completion, an average of 4 years
Measurement of urine blood (presence/absence).
Urinalysis(Nitrite)
Time frame: Through study completion, an average of 4 years
Measurement of urine nitrite (presence/absence).
Urinalysis(Urobilinogen)
Time frame: Through study completion, an average of 4 years
Measurement of urine urobilinogen (mg/dL).
Urinalysis( Microscopic Examination)
Time frame: Through study completion, an average of 4 years
Microscopic examination of urine (if abnormal).
Liver function tests(total protein)
Time frame: Through study completion, an average of 4 years
Measurement of total protein(g/dL)
Liver function tests(albumin)
Time frame: Through study completion, an average of 4 years
Measurement of albumin(g/dL)
Liver function tests(total bilirubin)
Time frame: Through study completion, an average of 4 years
Measurement of total bilirubin(mg/dL)
Liver function tests(aspartate transaminase)
Time frame: Through study completion, an average of 4 years
Measurement of aspartate transaminase(U/L)
Liver function tests(alanine aminotransferase)
Time frame: Through study completion, an average of 4 years
Measurement of alanine aminotransferase(U/L)
Liver function tests(alkaline phosphatase)
Time frame: Through study completion, an average of 4 years
alkaline phosphatase(U/L)
Liver function tests(gamma-glutamyl transferase)
Time frame: Through study completion, an average of 4 years
Measurement of gamma-glutamyl transferase(U/L)
Hematology(Hemoglobin)
Time frame: Through study completion, an average of 4 years
Measurement of hemoglobin(g/dL)
Hematology(hematocrit)
Time frame: Through study completion, an average of 4 years
Measurement of hematocrit(%)
Hematology(white blood cell count)
Time frame: Through study completion, an average of 4 years
Measurement of white blood cell count（/μL）
Hematology(red blood cell count)
Time frame: Through study completion, an average of 4 years
Measurement of red blood cell count（/μL)
Hematology(mean corpuscular volume)
Time frame: Through study completion, an average of 4 years
Measurement of mean corpuscular volume(fL)
Hematology(mean corpuscular hemoglobin)
Time frame: Through study completion, an average of 4 years
Measurement of mean corpuscular hemoglobin(pg)
Hematology(red blood cell distribution width)
Time frame: Through study completion, an average of 4 years
Measurement of red blood cell distribution width(％)
Hematology(platelet count)
Time frame: Through study completion, an average of 4 years
Measurement of platelet count(/μL)
Serum chemistry(blood urea nitrogen)
Time frame: Through study completion, an average of 4 years
Measurement of blood urea nitrogen(mg/dL)
Serum chemistry(calcium)
Time frame: Through study completion, an average of 4 years
Measurement of calcium(mg/dL)
Serum chemistry(chloride)
Time frame: Through study completion, an average of 4 years
Measurement of chloride(mEq/L)
Serum chemistry(creatinine)
Time frame: Through study completion, an average of 4 years
Measurement of creatinine(mg/dL)
Serum chemistry(total bilirubin)
Time frame: Through study completion, an average of 4 years
Measurement of total bilirubin(mg/dL)
Serum chemistry(direct bilirubin)
Time frame: Through study completion, an average of 4 years
Measurement of direct bilirubin(mg/dL)
Serum chemistry(alkaline phosphatase)
Time frame: Through study completion, an average of 4 years
Measurement of alkaline phosphatas（U/L）
Serum chemistry(alanine aminotransferase)
Time frame: Through study completion, an average of 4 years
Measurement of alanine aminotransferase(U/L)
Serum chemistry(gamma-glutamyl transferase)
Time frame: Through study completion, an average of 4 years
Measurement of gamma-glutamyl transferase(U/L)
Serum chemistry(total protein)
Time frame: Through study completion, an average of 4 years
Measurement of total protein(g/dL)
Serum chemistry(albumin)
Time frame: Through study completion, an average of 4 years
Measurement of albumin(g/dL)
Serum chemistry(globulin)
Time frame: Through study completion, an average of 4 years
Measurement of globulin(g/dL)
Serum chemistry(sodium)
Time frame: Through study completion, an average of 4 years
Measurement of sodium(mEq/L)
Serum chemistry(potassium)
Time frame: Through study completion, an average of 4 years
Measurement of potassium(mEq/L)
Serum chemistry(phosphorus)
Time frame: Through study completion, an average of 4 years
Measurement of phosphorus(mq/dL)
Serum chemistry(glucose)
Time frame: Through study completion, an average of 4 years
Measurement of glucose(mq/dL)
Heart rate
Time frame: Through study completion, an average of 4 years
heart rate (beats per minute)
Respiratory Rate
Time frame: Through study completion, an average of 4 years
Respiratory Rate (breaths per minute),
Blood Pressure
Time frame: Through study completion, an average of 4 years
blood pressure, both of systolic and diastolic (mm Hg)
Electrocardiogram (ECG) Findings
Time frame: Through study completion, an average of 4 years
ECG findings, including heart rate (beats per minute), PR Interval (milliseconds), PQ Interval (milliseconds), RR Interval (milliseconds), QRS Interval (milliseconds), and QT Interval (milliseconds), will be recorded.
Columbia-Suicide Severity Rating Scale (C-SSRS) Scores
Time frame: Through study completion, an average of 4 years
Scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) will be recorded. Questions regarding suicide are recorded as yes or no, and the percentage of subject with suicide risk (yes) is assessed.
1 secondary outcome
Percentage Change in all partial seizure frequency per 28-Day
Time frame: Through study completion, an average of 4 years
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 3 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.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cenobamate in people with Epilepsies, Partial, run by Ono Pharmaceutical Co., Ltd. at 29 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 1 inclusion and 2 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 3 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 29 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Through study completion, an average of 4 years). The study lists 47 primary outcomes in all. 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 3 Jun 2025.