Partial EpilepsyPhase 3NCT05067634
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
A Phase 3 study testing Xcopri in people with Partial Epilepsy, run by SK Life Science, Inc. at 35 sites in 7 countries.
Trial summary
Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- Xcopri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 35 sitesin 7 countries
- Study dates
- 10 Jan 2022to 2 Oct 2026
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have a diagnosis of epilepsy with partial-onset (focal) seizures (POS) with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures. A diagnosis should have been established at least 12 months prior to Visit 1 (Screening) by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)
- Male or female participant, from age 2 to less than 18 years at the time of informed consent/assent (dates including informed consent in YKP3089C039)
- Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb])
- Have had a brain imaging (e.g., magnetic resonance imaging [MRI] scan or computed tomography (CT) within 10 years before Visit 1 (Screening) that ruled out a progressive cause of epilepsy.
- For subjects new to Study YKP3089C040, participants must have had at least 1 POS seizure during the 28-day Baseline Period. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS
- Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1 (Screening). A vagal nerve stimulator [VNS] will not be counted as one of the 3 allowed AEDs but the settings should be stable for at least 4 weeks prior to Visit 1 (Screening).
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- Investigator believes subject could benefit from new or continued exposure to study drug
- Subjects entering from study YKP3089C039 must continue to meet all of the inclusion criteria from the YKP3089C039 study
- Subjects receiving felbamate as a concomitant AED must meet the following criteria:
- Have a 12-month history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening).
- No prior or known history of hepatotoxicity or hematologic disorder due to felbamate.
- Subjects following a ketogenic diet will be allowed as long as the diet has been stable for at least 30 days prior to Visit 1 (Screening) and will remain stable for the duration of the study
Who cannot join
- Females who are breastfeeding or pregnant at Screening or Baseline.
- Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 2 years before Visit 1 (Screening).
- Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1 (Screening).
- Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (e.g., significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1 (Screening), current psychotic disorder, acute mania).
- Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 [i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) in participants aged 6 and above, if able].
- Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1 (Screening); however, those who have previously documented "failed" epilepsy surgery will be allowed.
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- Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
- Presence of only nonmotor simple partial seizures or primary generalized epilepsies.
- Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs) of 31 to < 60 "milliliters per minute (mL/min)" and < 30 mL/min, respectively.
- Evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limit of normal (ULN).
- Evidence of significant active hematological disease; white blood cell (WBC) count equal or less than 2500/µL (2.50 1E+09/liter [L]) or an absolute neutrophil count equal or less than 1000/µL (1.00 1E+09/L).
- Subjects with Familial short QT syndrome.
- Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than 450 milliseconds (msec) or shortened corrected QT interval (QTc) defined as less than 340 msec.
- Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- Subject has a history of any serious drug-induced hypersensitivity reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or DRESS) or any drug-related rash requiring hospitalization.
- History of AED-associated rash that involved conjunctiva or mucosae.
- History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication.
- Concomitant use of vigabatrin. Participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 (Screening) and with documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in a visual perimetry test.
- A history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) more than once within the 30 days prior to Visit 1(Screening).
- A VNS implanted less than 5 months before Visit 1 (Screening) or changes in parameter less than 4 weeks before Visit 1 (or thereafter during the study).
- History of or a concomitant medical condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study or compromise the participant's ability to safely complete the study.
- Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1 (Screening), or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
- Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- For subjects new to Study YKP3089C040 previous exposure to cenobamate or sensitivity/allergy to components of the oral suspension.
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
United States14 sites
Child Neurology Consultants of Austin
Austin, Texas, 78731
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
Duke University Hospital
Durham, North Carolina, 27710
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Boston Children's Health Physicians - Neurology at Hawthorne
Hawthorne, New York, 10532
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Northeast Regional Epilepsy Group - Morristown
Morristown, New Jersey, 07960
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Clinical Integrative Research Center of Atlanta
Sandy Springs, Georgia, 30328
South Korea6 sites
Chungbuk National University Hospital
Cheonju
Korea University Guro Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
SMG-SNU Boramae Medical Center
Seoul
Ajou University Hospital
Suwon
Hungary4 sites
Bethesda Gyermekkorhaz
Budapest
Országos Klinikai Idegtudományi Intézet, Neurológiai Osztály
Budapest
Semmelweis University Dept. Of Paediatrics
Budapest
Servus Salvus Egészségügyi Szolgáltató Kft.
Budapest
Spain4 sites
Hospital Sant Joan de Déu Barcelona
Barcelona
Hospital Universitari Vall d'Hebrón
Barcelona
Hospital Infantil Universitario Niño Jesús
Madrid
Hospital Universitario Virgen del Rocío
Seville
Australia3 sites
Royal Children's Hospital Melbourne
Parkville
Sydney Children's Hospital - Randwick
Randwick
Children's Health Queensland Hospital and Health Service
South Brisbane
Poland3 sites
Niepubliczny Zaklad Opieki Zdrowotnej - Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce
Centrum Medyczne Plejady
Krakow
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow
About this study
Official title: Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Primary objective: To evaluate the safety and tolerability of cenobamate in 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 pediatric subjects with partial onset (focal) seizures
- To evaluate the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset seizures
- To evaluate the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures
- Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and the 12.5 mg tablets - Day 1, and Day 15
- Conditions
- Partial Epilepsy
- Being tested
- Xcopri
- Keywords
- Partial-onset (focal) seizures, Pediatrics
- Medical subject headings
- Epilepsies, Partial, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XcopriDrug
Age groups 12 to <18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to <12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to <6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to <4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
| Study group | Role | What they receive |
|---|---|---|
| 12 to < 18 year olds | Experimental | Not described Receives: Drug: Xcopri |
| 6 to <12 years old | Experimental | Not described Receives: Drug: Xcopri |
| 4 to <6 years old | Experimental | Not described Receives: Drug: Xcopri |
| 2 to <4 years old | Experimental | Not described Receives: Drug: Xcopri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and SAEs
Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.of age with partial-onset (focal) seizures
Measured: 3 Years
Secondary outcomes (2)
To collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures
The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri
Measured: 3 Years
Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets
Testing to determine how patients respond to the taste and route of Xcopri
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start10 Jan 2022
- Primary completion2 Oct 2026
- Study completion2 Oct 2026
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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sunita Misra, MD, Study director, SK Life Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067634
- Sponsor's protocol ID
- YKP3089C040
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
- ClinicalTrials.gov ID
- NCT05067634
- Acronym / sponsor ID
- YKP3089C040
- Conditions
- Partial Epilepsy
- Keywords
- Partial-onset (focal) seizures, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 5 Oct 2021 (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 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 pediatric subjects with partial onset (focal) seizures
- To evaluate the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset seizures
- To evaluate the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures
- Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and the 12.5 mg tablets - Day 1, and Day 15
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12 to < 18 year olds | Experimental | Drug: Xcopri |
| 6 to <12 years old | Experimental | Drug: Xcopri |
| 4 to <6 years old | Experimental | Drug: Xcopri |
| 2 to <4 years old | Experimental | Drug: Xcopri |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Have a diagnosis of epilepsy with partial-onset (focal) seizures (POS) with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures. A diagnosis should have been established at least 12 months prior to Visit 1 (Screening) by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)
- Male or female participant, from age 2 to less than 18 years at the time of informed consent/assent (dates including informed consent in YKP3089C039)
- Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb])
- Have had a brain imaging (e.g., magnetic resonance imaging [MRI] scan or computed tomography (CT) within 10 years before Visit 1 (Screening) that ruled out a progressive cause of epilepsy.
- For subjects new to Study YKP3089C040, participants must have had at least 1 POS seizure during the 28-day Baseline Period. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS
Key exclusion criteria (24 listed)
- Females who are breastfeeding or pregnant at Screening or Baseline.
- Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 2 years before Visit 1 (Screening).
- Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1 (Screening).
- Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (e.g., significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1 (Screening), current psychotic disorder, acute mania).
- Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 [i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) in participants aged 6 and above, if able].
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 |
|---|---|---|
| XcopriAge groups 12 to <18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to <12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to <6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to <4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study. | Drug | 12 to < 18 year olds, 2 to <4 years old, 4 to <6 years old, 6 to <12 years old |
Primary outcome
Incidence of Adverse Events and SAEs
Time frame: 3 Years
Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.of age with partial-onset (focal) seizures
2 secondary outcomes
To collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures
Time frame: 3 Years
Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets
Time frame: 3 Years
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 16 Oct 2026.
Related trials for Partial Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Active, not recruitingPhase 2
A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy
Focal Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Enrolling by invitationPhase 3
An Open-label Study of XEN1101 in Epilepsy
Focal Epilepsy, Tonic-Clonic Seizures
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.
Sunita Misra, MD study director
SK Life Science, Inc.
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xcopri in people with Partial Epilepsy, run by SK Life Science, Inc. at 35 sites in 7 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 12 inclusion and 24 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 16 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 35 sites in United States, South Korea, Hungary, Spain, Australia and 2 more countries. 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?
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?
Incidence of Adverse Events and SAEs (time frame: 3 Years). 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 16 Oct 2026.