Partial SeizurePhase 3NCT04557085
Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS
A Phase 3 study testing Cenobamate in people with Partial Seizure and Focal Seizure, run by SK Life Science, Inc. at 3 sites in 3 countries.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with POS, with optional OLE. The study consists of 4 periods as follows: An 8-week of Screening/Baseline Period, 24-week of Double-blind Treatment Period (including a 18-week Titration Phase and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Partial Seizure, Focal Seizure
- What is being tested?
- Cenobamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 519 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 8 Mar 2021to 21 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects must meet all of the following criteria to be enrolled in the study:
- Male or female subject and age 18 to 70 years inclusive at the time of signing the informed consent
- Weight at least 35 kg
- Written informed consent signed by the subject prior to entering the study in accordance with the ICH GCP guidelines. For subjects who lack the capacity, consent will be obtained from the parent/legal guardian. For all underaged subjects according to the specific laws of the country, both the written consent of the subject and the consent of the parent/legal guardian will be obtained.
- A diagnosis of partial onset seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and an electroencephalogram (EEG).
- EEG performed within 5 years prior to Visit 1 that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (i.e., clinical history). For chronic patients for which the current diagnosis is not very clear, additional EEG results older than 5 years but within 10 years may be used for final confirmation of epilepsy diagnosis.
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- Need additional antiepileptic drug (AED) treatment despite having been treated with at least one AED for the last 2 years.
- During the 8-week Screening/Baseline Period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8-week period. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the Screening/Baseline Periods, respectively.
- Currently on stable antiepileptic treatment regimen:
- Subject must have been receiving stable doses of 1 to 3 AEDs for at least 4 weeks prior to Visit 1 to be continued unchanged throughout the Double-blind Treatment Period.
- Vagal nerve stimulator (VNS) or deep brain stimulator (DBS) will not be counted as an AED; however, the parameters must remain stable for at least 4 weeks prior to Visit 1 and during the study. VNS or DBS must have been implanted at least 5 months prior to Visit 1.
- The daily use of benzodiazepines (except for diazepam) for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED and must be continued unchanged throughout the study. Therefore, only a maximum of 2 additional approved AEDs will be allowed.
- Subjects receiving felbamate as a concomitant AED must meet the following criteria:
- Two-year history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 ii. No prior or known history of hepatotoxicity or hematologic disorder due to felbamate
- Computed tomography (CT) or magnetic resonance imaging (MRI) scan performed within the past 5 years that ruled out a progressive cause of epilepsy. If brain imaging has not been performed within the past 5 years, a CT scan must be performed prior to randomization. For chronic patients for which the current diagnosis is not very clear, additional CT or MRI results older than 5 years but within 10 years may be used for final confirmation of epilepsy diagnosis.
- Ability to reach subject by telephone
- Use of an acceptable form of birth control by female subjects of childbearing potential
- Subject taking a ketogenic diet will be allowed as long as the diet has been stable for at least 3 months prior to Visit 1 and will remain stable for the duration of the study.
Who cannot join
- Female subjects who are pregnant (or planning to become pregnant during the study), lactating or breast-feeding
- History of non-epileptic or psychogenic seizures
- Presence of only non-motor simple partial seizures or primary generalized epilepsies
- History of seizure clusters (episodes lasting less than 30 minutes in which multiple seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) within 6 months prior to Visit 1
- Presence or previous history of Lennox-Gastaut syndrome
- Scheduled epilepsy surgery within 8 months of Visit 1
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- Evidence of any clinically significant laboratory abnormalities or disease (e.g., psychiatric, behavioral problems, cardiac, respiratory, gastrointestinal, hepatic [liver transaminases, ALT or AST, more than twice the upper limit of normal (ULN) or total or direct bilirubin not within normal limits], or renal disease) that, in the opinion of the Investigator, could affect subject's safety or conduct of the study.
- Any clinically significant active central nervous system (CNS) infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
- Presence of psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; presence or recent history (within 6 months) of major depressive episode
- Use of intermittent rescue benzodiazepines more than once per month (1 to 2 doses in a 24-hour period is considered as 1 rescue) in the 1-month period prior to Visit 1
- Current or recent use (within 30 days prior to Visit 1) of any of the following medications: diazepam/phenytoin/phenobarbital (or metabolites of these drugs), clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, efavirenz, natural progesterone, or traditional Chinese/herbal medicines indicated for neurological system
- Current or recent (within 5 months prior to Visit 1) use of vigabatrin or ezogabine. Subjects with a prior history of treatment with vigabatrin must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test. Subjects with a prior history of treatment with ezogabine should have no evidence of retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies.
- Previous exposure to cenobamate
- Participation in any other trials involving an investigational product or device within 30 days prior to Visit 1
- History of alcoholism, drug abuse, or drug addiction within the past 2 years prior to Visit 1 as assessed by the Investigator
- History of status epilepticus within 3 months of Visit 1
- 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]) or any drug-related rash requiring hospitalization
- History of AED-associated rash that involved conjunctiva or mucosae
- History of any drug-related hypersensitivity reaction that required discontinuation of the medication
- Presence of Familial short QT syndrome or relevant replicated QTc interval (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females) on electrocardiogram (ECG)
- Absolute neutrophil count less than 1,500/μL
- Platelet counts lower than 80,000/μL in subjects treated with VPA
- Creatinine clearance less than 60 mL/min, as calculated by Cockcroft-Gault equation
- History of positive test results for HBsAg, HCV-Ab, and HIV-Ab
- More than 1 lifetime suicide attempt
- A "YES" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Suicidal Ideation section in the past 6 months or a "YES" answer to any of the Suicidal Behavior Questions in the past 2 years
- Subject is a staff member or immediate family member of study staff.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with POS, with optional OLE. The study consists of 4 periods as follows: An 8-week of Screening/Baseline Period, 24-week of Double-blind Treatment Period (including a 18-week Titration Phase and 6-week Maintenance Phase), 52-week of Open-label Extension (OLE) Period (applicable for subjects who participate in the OLE) and up to 5-week of End of Study (EOS) Follow-up Period.
The purpose of this study is to evaluate the efficacy and safety of 100, 200 and 400 mg/day of cenobamate as adjunctive therapy compared with placebo in subjects with partial onset seizures (POS).
The study will also evaluate the long-term safety and tolerability of cenobamate adjunctive therapy in subjects with POS who have completed the double-blind treatment period.
Read the detailed description
Subjects will undergo an 8-week Screening/Baseline Period to assess seizure frequency. Subjects with a high enough number of seizures will be randomized in a 1:1:1:1 ratio to receive placebo or cenobamate 100, 200, or 400 mg given once per day in the morning. Subjects will first enter the 18-week Titration Phase, during which the initial dose will be 12.5 mg/day or placebo. The dose of cenobamate will be increased in a double-blind fashion from 12.5 mg/day to 25 mg/day and 50 mg/day (or matching placebo) at 2-week intervals and then will be titrated by 50 mg/day (or matching placebo) every 2 weeks. After 18-week up-titration, subjects will enter the Maintenance Phase. During the Maintenance Phase, subjects are recommended to maintain their dose for 6 weeks. Subjects who have completed the Double-blind Treatment Period and who choose to participate in this OLE will enter an 18-week Double-blind Conversion Phase before starting the 34-week Open-label Maintenance Phase. Subjects who do not enroll into the OLE will enter a 5-week FU period.
The primary objective of this study is to evaluate the efficacy of cenobamate as adjunctive therapy compared with placebo in subjects with POS. The secondary objectives of this study are: To evaluate the safety and tolerability of cenobamate in subjects with POS, to evaluate the effect of cenobamate in POS and in specified seizure types, and to assess blood plasma exposure of cenobamate in subjects with POS.
- Conditions
- Partial Seizure, Focal Seizure
- Being tested
- Cenobamate, Placebo
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenobamateDrug
Cenobamate tablets
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Cenobamate 100 mg/day | Experimental | Cenobamate 100 mg/day Receives: Drug: Cenobamate |
| Cenobamate 200 mg/day | Experimental | Cenobamate 200 mg/day Receives: Drug: Cenobamate |
| Cenobamate 400 mg/day | Experimental | Cenobamate 400 mg/day Receives: Drug: Cenobamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in seizure frequency (seizure rate per 28-day interval) of all simple partial motor, complex partial, or secondarily generalized seizures during the Maintenance Phase.
Measured: per 28 days during 6 week maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start8 Mar 2021
- Primary completion16 Feb 2024
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Partial 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 519 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
- NCT04557085
- Sponsor's protocol ID
- YKP3089C035
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2020
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu P, Wu X, Cui L, Pan S, Han Y, Xu H, Zhu S, Wang X, Huang H, Wang T, Liao W, Zhang M, Tang L, Sun H, Qin B, Hu Z, Feng J, Chen Y, Zhang M, Li Q, Han X, Xiao B, Chen H, Li L, Liang Y, Ye H, Liu Y, Hong Z, Zhou D. Efficacy and Safety of Adjunctive Cenobamate in Chinese Participants with Focal Seizure. Adv Ther. 2026 Feb;43(2):688-709. doi: 10.1007/s12325-025-03432-z. Epub 2025 Dec 22.
PubMed 41428177Wu X, Chen L, Choe E, Heo K, Hong SB, Iida K, Jeon YH, Jung J, Kamin M, Kawai K, Kim JH, Kim MW, Lee SK, Misra SN, Park J, Rosenfeld WE, Wang T, Yamamoto T, Yu P, Ferrari L. Efficacy of adjunctive cenobamate by focal seizure subtypes: a randomized, double-blind, placebo-controlled, multicenter study in a multinational Asian population. Seizure. 2025 Dec;133:43-51. doi: 10.1016/j.seizure.2025.09.021. Epub 2025 Sep 29.
PubMed 41101116
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension
- ClinicalTrials.gov ID
- NCT04557085
- Acronym / sponsor ID
- YKP3089C035
- Conditions
- Partial Seizure, Focal Seizure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 21 Sep 2020 (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.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with POS, with optional OLE. The study consists of 4 periods as follows: An 8-week of Screening/Baseline Period, 24-week of Double-blind Treatment Period (including a 18-week Titration Phase and 6-week Maintenance Phase), 52-week of Open-label Extension (OLE) Period (applicable for subjects who participate in the OLE) and up to 5-week of End of Study (EOS) Follow-up Period.
The purpose of this study is to evaluate the efficacy and safety of 100, 200 and 400 mg/day of cenobamate as adjunctive therapy compared with placebo in subjects with partial onset seizures (POS).
The study will also evaluate the long-term safety and tolerability of cenobamate adjunctive therapy in subjects with POS who have completed the double-blind treatment period.
Detailed description
Subjects will undergo an 8-week Screening/Baseline Period to assess seizure frequency. Subjects with a high enough number of seizures will be randomized in a 1:1:1:1 ratio to receive placebo or cenobamate 100, 200, or 400 mg given once per day in the morning. Subjects will first enter the 18-week Titration Phase, during which the initial dose will be 12.5 mg/day or placebo. The dose of cenobamate will be increased in a double-blind fashion from 12.5 mg/day to 25 mg/day and 50 mg/day (or matching placebo) at 2-week intervals and then will be titrated by 50 mg/day (or matching placebo) every 2 weeks. After 18-week up-titration, subjects will enter the Maintenance Phase. During the Maintenance Phase, subjects are recommended to maintain their dose for 6 weeks. Subjects who have completed the Double-blind Treatment Period and who choose to participate in this OLE will enter an 18-week Double-blind Conversion Phase before starting the 34-week Open-label Maintenance Phase. Subjects who do not enroll into the OLE will enter a 5-week FU period.
The primary objective of this study is to evaluate the efficacy of cenobamate as adjunctive therapy compared with placebo in subjects with POS. The secondary objectives of this study are: To evaluate the safety and tolerability of cenobamate in subjects with POS, to evaluate the effect of cenobamate in POS and in specified seizure types, and to assess blood plasma exposure of cenobamate in subjects with POS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Cenobamate 100 mg/day | Experimental | Drug: CenobamateCenobamate 100 mg/day |
| Cenobamate 200 mg/day | Experimental | Drug: CenobamateCenobamate 200 mg/day |
| Cenobamate 400 mg/day | Experimental | Drug: CenobamateCenobamate 400 mg/day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female subject and age 18 to 70 years inclusive at the time of signing the informed consent
- Weight at least 35 kg
- Written informed consent signed by the subject prior to entering the study in accordance with the ICH GCP guidelines. For subjects who lack the capacity, consent will be obtained from the parent/legal guardian. For all underaged subjects according to the specific laws of the country, both the written consent of the subject and the consent of the parent/legal guardian will be obtained.
- A diagnosis of partial onset seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and an electroencephalogram (EEG).
- EEG performed within 5 years prior to Visit 1 that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (i.e., clinical history). For chronic patients for which the current diagnosis is not very clear, additional EEG results older than 5 years but within 10 years may be used for final confirmation of epilepsy diagnosis.
Key exclusion criteria (27 listed)
- Female subjects who are pregnant (or planning to become pregnant during the study), lactating or breast-feeding
- History of non-epileptic or psychogenic seizures
- Presence of only non-motor simple partial seizures or primary generalized epilepsies
- History of seizure clusters (episodes lasting less than 30 minutes in which multiple seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) within 6 months prior to Visit 1
- Presence or previous history of Lennox-Gastaut syndrome
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 tablets | Drug | Cenobamate 100 mg/day, Cenobamate 200 mg/day, Cenobamate 400 mg/day |
| PlaceboMatching placebo tablets | Drug | Placebo |
Primary outcome
Percent change from baseline in seizure frequency (seizure rate per 28-day interval) of all simple partial motor, complex partial, or secondarily generalized seizures during the Maintenance Phase.
Time frame: per 28 days during 6 week maintenance phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 41428177Yu P, Wu X, Cui L, Pan S, Han Y, Xu H, Zhu S, Wang X, Huang H, Wang T, Liao W, Zhang M, Tang L, Sun H, Qin B, Hu Z, Feng J, Chen Y, Zhang M, Li Q, Han X, Xiao B, Chen H, Li L, Liang Y, Ye H, Liu Y, Hong Z, Zhou D. Efficacy and Safety of Adjunctive Cenobamate in Chinese Participants with Focal Seizure. Adv Ther. 2026 Feb;43(2):688-709. doi: 10.1007/s12325-025-03432-z. Epub 2025 Dec 22.
- Derived from this study: PubMed 41101116Wu X, Chen L, Choe E, Heo K, Hong SB, Iida K, Jeon YH, Jung J, Kamin M, Kawai K, Kim JH, Kim MW, Lee SK, Misra SN, Park J, Rosenfeld WE, Wang T, Yamamoto T, Yu P, Ferrari L. Efficacy of adjunctive cenobamate by focal seizure subtypes: a randomized, double-blind, placebo-controlled, multicenter study in a multinational Asian population. Seizure. 2025 Dec;133:43-51. doi: 10.1016/j.seizure.2025.09.021. Epub 2025 Sep 29.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: 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 Partial Seizure and Focal Seizure, run by SK Life Science, Inc. at 3 sites in 3 countries.
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 18 inclusion and 27 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: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Japan, South Korea. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change from baseline in seizure frequency (seizure rate per 28-day interval) of all simple partial motor, complex partial, or secondarily generalized seizures during the Maintenance Phase. (time frame: per 28 days during 6 week maintenance phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557085, which also lists 2 linked publications.
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 2026; AzTrials last refreshed its copy on 28 Oct 2026.