Focal Onset SeizurePhase 4NCT06453213
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
A Phase 4 study testing Cenobamate in people with Focal Onset Seizure, run by SK Life Science, Inc. at 19 sites in United States.
Trial summary
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Focal Onset Seizure
- What is being tested?
- Cenobamate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 19 sitesUnited States
- Study dates
- 14 Oct 2024to 9 Jul 2027
- Phase
- Phase 4
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them.
- Male or female subjects 18-74 years of age with a diagnosis of partial-onset seizures (POS) according to the 2017 ILAE Classification of Epileptic Seizures. Diagnosis will be established by clinical history and an electroencephalogram (EEG) consistent with POS. Subjects with a normal EEG could be included provided they met the other diagnostic criteria according to clinical history.
- Subjects who are newly diagnosed or have recurrent epilepsy and have experienced:
- At least 2 unprovoked seizures (at least >24 hours apart) within the 1 year prior to Day 1 of the Treatment Period, of which, at least 1 unprovoked seizure (but below 20 seizures) occurred in the 12 weeks prior to Day 1 of the Treatment Period.
- OR
- 1 unprovoked seizure within the 12 weeks prior to Day 1 of the Treatment Period with concomitant information to support an increased risk (>60%) of a second seizure. In the absence of clear information about recurrence risk, or even knowledge of such information, the default definition of epilepsy originates at the second unprovoked seizure.
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- Subjects who are newly diagnosed and have been prescribed a low dose of 1 ASM for ≤12 weeks can be included if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks after the 1st dose of cenobamate. For subjects with recurrent epilepsy, they must have relapsed at least 6 months after the end of the last ASM treatment but can have been prescribed a low dose of 1 ASM for ≤12 weeks if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks after the 1st dose of cenobamate.
- Female subjects are either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 2 weeks after last dose of study drug.
- Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study.
- Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements.
Who cannot join
- Subjects who have only simple partial-onset seizures (focal aware seizures) without motor signs.
- Subjects who have seizure clusters where individual seizures cannot be counted.
- Subjects who present with or have a history of Lennox-Gastaut syndrome.
- Subjects who have a history of status epilepticus that required hospitalization within 1 year prior to Day 1 of the Treatment Period.
- Subjects who have a history of psychogenic non-epileptic seizures within 2 years prior to Day 1 of the Treatment Period.
- Subjects who have a history of active suicidal ideation within the last 6 months or suicide attempt within 2 years prior to Day 1 of Treatment Period.
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- Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, psychiatric, other neurological) that in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments.
- History of Familial Short QT syndrome or prior subject diagnosis of Short QT syndrome.
- Evidence of clinically significant active renal or hepatic disease.
- Subjects taking a strong CYP3A inducer such as phenytoin, phenobarbital, carbamazepine, or rifampin within 12 weeks prior to the Pretreatment Period unless emergency care was needed due to the subject experiencing status epilepticus, uncontrolled seizures, or clusters of seizures.
- Subjects who are taking more than one of the following centrally acting drugs: antipsychotic, antidepressant, or anxiolytic. The dose should be stable for the 12 weeks prior to the Pretreatment Period.
- Subjects who have a history of any type of surgery for brain or central nervous system within 1 year prior to the Pretreatment Period.
- Subjects who have a history of receiving any ASM (including ASM used as rescue treatment and ASMs used for indications other than epilepsy) for more than 12 weeks in total within 6 months prior to Day 1 of the Treatment Period.
- Subjects who have used intermittent rescue medicine on 2 or more occasions within 12 weeks before the Pretreatment Period (1 to 2 doses over a 24-hour period considered one-time rescue).
- Subjects who have a history of receiving any ASM polytherapy (> 2 ASMs taken concurrently) during a previous episode of epilepsy.
- Previous exposure to cenobamate or sensitivity/allergy to components of the oral tablets.
- Subjects who have a history of drug or alcohol dependency or abuse within the last 2 years before the Pretreatment Period.
- Subjects who have had multiple drug allergies or a severe drug reaction, including dermatological (eg, DRESS syndrome, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
- Females who are breastfeeding or pregnant or planning to get pregnant in the Pretreatment Period or during the conduct of the study.
- Subjects who have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
- Subjects with dementia.
- Subjects who have seizures due to a progressive CNS condition.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
John Hopkins Epilepsy Center
Baltimore, Maryland, 21287
Consultants In Epilepsy and Neurology
Boise, Idaho, 83702
University of Missouri Health Care
Columbia, Missouri, 65212
Henry Ford Health System
Detroit, Michigan, 48202
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
Neuro Pain Medical Center
Fresno, California, 93710
Hartford Hospital
Hartford, Connecticut, 06102
Bluegrass Epilepsy Research LLC
Lexington, Kentucky, 40504
Clinical Trials Inc
Little Rock, Arkansas, 72205
Elite Clinical Research
Miami, Florida, 33144
Yale School of Medicine - Yale-New Haven Hospital
New Haven, Connecticut, 06519
NY Neurology Associates
New York, New York, 10003
Mount Sinai Hospital
New York, New York, 10029
Hoag Physician Partners
Newport Beach, California, 92663
Arizona Neuroscience Research
Phoenix, Arizona, 85032
Wayne Neurology PLC
Plymouth, Michigan, 48170
Knight Neurology
Rockledge, Florida, 32955
Louisiana State University Health Sciences
Shreveport, Louisiana, 71103
Center For Neurosciences
Tucson, Arizona, 85718
About this study
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.
Read the detailed description
This is an uncontrolled, single-arm, open-label, Phase IV study conducted at approximately 40 sites in the US. It will consist of the following Periods:
- Pretreatment Period (up to 21 days)
- 100 mg/day Treatment Period (6-week Titration Phase, 26-week Maintenance Phase)
- 200 mg/day Treatment Period (2-week Titration Phase, 26-week Maintenance Phase)
- 26-week Optional Extension Period
- Follow Up Period (4 weeks)
Pretreatment Period At the screening visit (Visit 1) the investigator will obtain informed consent and assess the subject for their eligibility to participate in the study. The investigator will review any available hematology, chemistry blood tests, and ECGs. Vital signs and routine physical and neurological exam will be performed.
100 mg/day Treatment Period Subjects who complete screening and meet the inclusion/exclusion criteria begin the 32-week Treatment Period which includes a 6-week Titration Phase and a 26-week Maintenance Phase. During the Titration Phase subjects will be treated with cenobamate 12.5 mg/day for two weeks, 25 mg/day for two weeks and 50 mg/day for two weeks. Subjects tolerating cenobamate at the end of the Titration Phase will continue treatment with 100 mg/day in the Maintenance Phase for 26 weeks. At the end of the Maintenance Phase, the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate. Subjects who experience a certain type of seizure during the 100 mg/day Maintenance Phase (with or without rescue medication use) will transition to the 200 mg/day Treatment Period.
200 mg/day Treatment Period: The 200 mg/day Treatment Period consists of a 2-week Titration Phase and a 26-week Maintenance Phase. During the 2-week Titration Phase, subjects will receive cenobamate 150 mg/day before entering the 26-week 200 mg/day Maintenance Phase. At the end of the Maintenance Phase, the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate. If the subject experiences a certain type of seizure at 200 mg/day during the Maintenance Phase, then they will be discontinued from the study.
Optional Extension Period:
An Optional Extension Period will last 26 weeks. During the Optional Extension Period, Visits will occur at 13th week (Day 315/287a, Visit 8/8a) and 26th week (Day 406/378a, Visit 9/9a) to record vital signs and identify adverse events and occurrence of a seizure using a seizure diary. If a certain type of seizure occurs during the Optional Extension Period, the subject will be discontinued from the study.
Follow-up Period:
If a subject prematurely discontinues from the study, is not continuing into the Optional Extension Period or completes the last visit in the Optional Extension Period, cenobamate should either be discontinued or will be titrated down by 50% for two weeks and then discontinued depending on the current dose. A follow-up visit should occur two weeks after the date of cenobamate discontinuation except in specific circumstances.
- Conditions
- Focal Onset Seizure
- Being tested
- Cenobamate
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenobamateDrug
The 100 mg/ day Treatment Period includes a 6-week Titration Phase and a 26-week Maintenance Phase. During the Titration Phase subjects will be treated with cenobamate 12.5 mg/day for two weeks, 25 mg/day for two weeks and 50 mg/day for two weeks. Subjects tolerating cenobamate at the end of the Titration Phase will continue treatment with 100 mg/day in the Maintenance Phase for 26 weeks. If the subject does not experience a certain type of seizure in the 100 mg/day Maintenance Phase, he/she can enter the Optional Extension Period (100 mg/day).
The 200 mg/day treatment period consists of a 2-week Titration Phase and a 26-week Maintenance Phase. During the 2-week Titration Phase, subjects will receive cenobamate 150 mg/day before entering the 26-week 200 mg/day Maintenance Phase. If the subject does not experience a certain type of seizure during the 200 mg/day Maintenance Phase, he/she can enter the 26 week Optional Extension Period (200 mg/day).
| Study group | Role | What they receive |
|---|---|---|
| Cenobamate | Experimental | All enrolled subjects will automatically participate in the Cenobamate arm since this is a single-arm study. Receives: Drug: Cenobamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period
The number (percentage) of subjects with POS who achieved seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period.
Measured: 32 weeks
Secondary outcomes (4)
Seizure freedom during each of the 26-week Maintenance Phases
The number (percentage) of subjects with POS who achieved seizure freedom during each of the 26-week Maintenance Phases regardless of cenobamate dose (last evaluated dose of 100 mg/day or 200 mg/day).
Measured: 60 weeks
Time to first seizure onset
Time to first seizure onset (defined as the period from the first cenobamate dose in the Maintenance Phase to first seizure onset).
Measured: 52 weeks
Time to withdrawal from the study
Time to withdrawal from the study (defined as the period from the first dose of cenobamate in the Maintenance Phase to the date of study withdrawal).
Measured: 86 weeks
Number (percentage) of subjects with POS who achieved seizure freedom during the 52-week treatment
The number (percentage) of subjects with POS who achieved seizure freedom during the 52-week treatment (ie, 26-week Maintenance Phase plus Optional 26-week Extension Period).
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start14 Oct 2024
- Primary completion26 May 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Onset SeizureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453213
- Sponsor's protocol ID
- YKP3089C049
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
- ClinicalTrials.gov ID
- NCT06453213
- Acronym / sponsor ID
- YKP3089C049
- Conditions
- Focal Onset Seizure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 11 Jun 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.
Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.
Detailed description
This is an uncontrolled, single-arm, open-label, Phase IV study conducted at approximately 40 sites in the US. It will consist of the following Periods:
- Pretreatment Period (up to 21 days)
- 100 mg/day Treatment Period (6-week Titration Phase, 26-week Maintenance Phase)
- 200 mg/day Treatment Period (2-week Titration Phase, 26-week Maintenance Phase)
- 26-week Optional Extension Period
- Follow Up Period (4 weeks)
Pretreatment Period At the screening visit (Visit 1) the investigator will obtain informed consent and assess the subject for their eligibility to participate in the study. The investigator will review any available hematology, chemistry blood tests, and ECGs. Vital signs and routine physical and neurological exam will be performed.
100 mg/day Treatment Period Subjects who complete screening and meet the inclusion/exclusion criteria begin the 32-week Treatment Period which includes a 6-week Titration Phase and a 26-week Maintenance Phase. During the Titration Phase subjects will be treated with cenobamate 12.5 mg/day for two weeks, 25 mg/day for two weeks and 50 mg/day for two weeks. Subjects tolerating cenobamate at the end of the Titration Phase will continue treatment with 100 mg/day in the Maintenance Phase for 26 weeks. At the end of the Maintenance Phase, the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate. Subjects who experience a certain type of seizure during the 100 mg/day Maintenance Phase (with or without rescue medication use) will transition to the 200 mg/day Treatment Period.
200 mg/day Treatment Period: The 200 mg/day Treatment Period consists of a 2-week Titration Phase and a 26-week Maintenance Phase. During the 2-week Titration Phase, subjects will receive cenobamate 150 mg/day before entering the 26-week 200 mg/day Maintenance Phase. At the end of the Maintenance Phase, the subject will have the option of continuing on in a 26-week Extension Period or discontinuing cenobamate. If the subject experiences a certain type of seizure at 200 mg/day during the Maintenance Phase, then they will be discontinued from the study.
Optional Extension Period:
An Optional Extension Period will last 26 weeks. During the Optional Extension Period, Visits will occur at 13th week (Day 315/287a, Visit 8/8a) and 26th week (Day 406/378a, Visit 9/9a) to record vital signs and identify adverse events and occurrence of a seizure using a seizure diary. If a certain type of seizure occurs during the Optional Extension Period, the subject will be discontinued from the study.
Follow-up Period:
If a subject prematurely discontinues from the study, is not continuing into the Optional Extension Period or completes the last visit in the Optional Extension Period, cenobamate should either be discontinued or will be titrated down by 50% for two weeks and then discontinued depending on the current dose. A follow-up visit should occur two weeks after the date of cenobamate discontinuation except in specific circumstances.
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: CenobamateAll enrolled subjects will automatically participate in the Cenobamate arm since this is a single-arm study. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be considered reliable and willing to be available for the study period and are able to record seizures and report adverse events (AEs) himself/herself or have a caregiver who can record seizures and report AEs for them.
- Male or female subjects 18-74 years of age with a diagnosis of partial-onset seizures (POS) according to the 2017 ILAE Classification of Epileptic Seizures. Diagnosis will be established by clinical history and an electroencephalogram (EEG) consistent with POS. Subjects with a normal EEG could be included provided they met the other diagnostic criteria according to clinical history.
- Subjects who are newly diagnosed or have recurrent epilepsy and have experienced:
- OR
- Subjects who are newly diagnosed and have been prescribed a low dose of 1 ASM for ≤12 weeks can be included if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks after the 1st dose of cenobamate. For subjects with recurrent epilepsy, they must have relapsed at least 6 months after the end of the last ASM treatment but can have been prescribed a low dose of 1 ASM for ≤12 weeks if the other ASM can be safely down-titrated/discontinued per Investigator discretion within 6 weeks after the 1st dose of cenobamate.
Key exclusion criteria (22 listed)
- Subjects who have only simple partial-onset seizures (focal aware seizures) without motor signs.
- Subjects who have seizure clusters where individual seizures cannot be counted.
- Subjects who present with or have a history of Lennox-Gastaut syndrome.
- Subjects who have a history of status epilepticus that required hospitalization within 1 year prior to Day 1 of the Treatment Period.
- Subjects who have a history of psychogenic non-epileptic seizures within 2 years prior to Day 1 of the Treatment Period.
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 |
|---|---|---|
| CenobamateThe 100 mg/ day Treatment Period includes a 6-week Titration Phase and a 26-week Maintenance Phase. During the Titration Phase subjects will be treated with cenobamate 12.5 mg/day for two weeks, 25 mg/day for two weeks and 50 mg/day for two weeks. Subjects tolerating cenobamate at the end of the Titration Phase will continue treatment with 100 mg/day in the Maintenance Phase for 26 weeks. If the subject does not experience a certain type of seizure in the 100 mg/day Maintenance Phase, he/she can enter the Optional Extension Period (100 mg/day). The 200 mg/day treatment period consists of a 2-week Titration Phase and a 26-week Maintenance Phase. During the 2-week Titration Phase, subjects will receive cenobamate 150 mg/day before entering the 26-week 200 mg/day Maintenance Phase. If the subject does not experience a certain type of seizure during the 200 mg/day Maintenance Phase, he/she can enter the 26 week Optional Extension Period (200 mg/day). | Drug | Cenobamate |
Primary outcome
Seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period
Time frame: 32 weeks
The number (percentage) of subjects with POS who achieved seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period.
4 secondary outcomes
Seizure freedom during each of the 26-week Maintenance Phases
Time frame: 60 weeks
Time to first seizure onset
Time frame: 52 weeks
Time to withdrawal from the study
Time frame: 86 weeks
Number (percentage) of subjects with POS who achieved seizure freedom during the 52-week treatment
Time frame: 52 weeks
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 27 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cenobamate in people with Focal Onset Seizure, run by SK Life Science, Inc. at 19 sites in United States.
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 10 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 27 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 19 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period (time frame: 32 weeks). 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 27 Oct 2026.