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Partial EpilepsyPhase 1NCT04903314

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

A Phase 1 study testing Xcopri in people with Partial Epilepsy, run by SK Life Science, Inc. at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
13 sitesin 3 countries
Study dates
27 May 2021to 6 Nov 2025
Phase
Phase 1
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

  • Diagnosis of epilepsy with partial-onset 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 6 months prior to Visit 1 by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allows provided that the participant meets the other diagnosis criterion (i.e., clinical history, including a history of treatment failure with at least 2 AEDs)
  • Male or female subjects, from age 2 to less than 18 years at the time of informed consent
  • Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb])
  • Written informed consent signed by the subject, legal guardian, or legally authorized representative (LAR) prior to entering the study in accordance with the ICH GCP guidelines. Age appropriate assent will be obtained for children and adolescents. If the written informed consent is provided by the legal guardian or LAR because the subject is unable to do so, a written or verbal assent from the subject must also be obtained
  • Are currently being treated with stable doses of 1 to a maximum of 2 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks prior to Visit 1. A vagal nerve stimulator (VNS) will not be counted as one of the 2 allowable AEDs
  • In the Investigator's opinion, parents or caregivers must be able to report accurate seizure assessments during the screening and study periods and subjects must be able to ingest study drug
  • Subjects with an implanted vagal nerve stimulator will be allowed if the vagal nerve stimulator was implanted at least 5 months prior to Visit 1 (Screening) and the stimulator parameters have not been changed for 30 days prior to Visit 1 and for the duration of the study
  • 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

  • Progressive neurological disease, including degenerative CNS diseases and progressive tumors
  • Evidence of clinically significant disease or any medical condition that would compromise the subject's ability to safely complete the study including, but not limited to, hepatic or renal failure, ischemic disease, human immunodeficiency virus (HIV) infection, active sexually transmitted disease (STD), active viral hepatitis, or malignancy
  • Positive urine screen of drugs of abuse (if not due to concomitant medication, e.g., benzodiazepines as hypnotics) for Cohort 1 subjects.
  • History of anoxic episodes require resuscitation within 6 months before Visit 1, drug or alcohol dependency or abuse within approximately the last 2 years or use of illegal recreational drugs.
  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product
  • Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I)
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  • Consumption of grapefruit or grapefruit-containing products within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I)
  • Significant clinical laboratory abnormalities, including elevation of serum AST or ALT more than 2 times the upper limit or normal (ULN) for each age group.
  • Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before Day 1
  • Scheduled for surgery during the study
  • Ketogenic diet or vagal nerve stimulation that has undergone alteration within 30 days of Visit 1
  • Treatment with an investigational drug or device (other than VNS) ≤ 30 days before Visit 1
  • Females who are breastfeeding or pregnant at Screening or Baseline or who are of reproductive age and do not agree to be abstinent or to use highly effective methods of contraception
  • Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1
  • Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1
  • 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., in the judgement of the investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months before Visit 1, current psychotic disorder, acute mania)
  • Any suicidal ideation with intent or without a plan within 6 months before Visit 2 in participants aged 6 and above.
  • Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the participant's safety or interfere with study assessments
  • Evidence of significant hematological disease; white blood cell (WBC) count equal or less than 2500/μL (2.50 1E+09/L) or an absolute neutrophil count equal or less than 1000/μL (1.00 1E+09/L)
  • Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than 450 msec or shortened corrected QT interval (QTc) defined as less than 350 msec
  • Subject has a history or 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 or 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 phenytoin and clobazam as these drugs may influence cenobamate plasma exposure. Subjects who took phenytoin or clobazam in the past must be off these drugs for at least 30 days prior to Visit 1.
  • Concomitant use of vigabatrin. Participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 and with documentation showing no evidence of 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 twice within the 30 days prior to Visit 1 (Screening)
  • A VNS implanted less than 5 months before Visit 1 or changes in parameter less than 30 days before Visit 1 (or thereafter during the study)
  • 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)

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

United States8 sites

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • Missouri University Pediatric and Adolescent Specialty Clinic

    Columbia, Missouri, 65201

  • Duke University

    Durham, North Carolina, 27705

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • MultiCare Institute - Mary Bridge Children's Neurology

    Tacoma, Washington, 98405

Other trials in United States

South Korea4 sites

  • Chungbuk National University Hospital

    Cheonju

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

Hungary1 site

  • I. Sz. Gyermekgyógyászati Klinika

    Budapest

Other trials in Hungary

About this study

Official title: A Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.

Read the detailed description

The secondary objective of this study is to evaluate the safety and tolerability of cenobamate (YKP3089) following single and multiple dosing.

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

    Xcopri will be administered orally not to exceed 400mg/day adult equivalent

Study groups in NCT04903314
Study groupRoleWhat they receive
Cohort IExperimentalXcopri to be administered to ages 12 to < 18 years not to exceed 400 mg/day.
Receives: Drug: Xcopri
Cohort IIaExperimentalXcopri to be administered to ages 6 to < 12 years not to exceed 400 mg/day.
Receives: Drug: Xcopri
Cohort IIbExperimentalXcopri to be administered to ages 4 to < 6 years not to exceed 400 mg/day.
Receives: Drug: Xcopri
Cohort IIIExperimentalXcopri to be administered to ages 2 to < 4 years not to exceed 400 mg/day.
Receives: Drug: Xcopri

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri

    Safety Assessment

    Measured: 18 Months

  2. The maximum plasma concentration (Cmax) after a single and multiple doses of Xcopri

    Safety Assessment

    Measured: 18 Months

Secondary outcomes (1)

  1. Safety - adverse events (AEs) reporting after a single and multiple doses of Xcopri

    Adverse event assessment for seriousness (yes, no), severity (mild, moderate, severe), affect on Xcopri dosing (increase, reduced, interrupted, withdrawn, no change), and outcome (recovered/resolved,recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, fatal or unknown).

    Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start27 May 2021
  3. Primary completion6 Nov 2025
  4. Study completion6 Nov 2025

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Cohort I will enroll 6 subjects. Upon review of Cohort I's PK analysis, a dose will be determined for Cohort IIa. Upon review of Cohot IIa's PK analysis, a dose will be determined for Cohort 11b and Cohort III.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04903314
Sponsor's protocol ID
YKP3089C039
Status last verified
Sep 2025
First submitted
21 May 2021
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Xcopri in people with Partial Epilepsy, run by SK Life Science, Inc. at 13 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 8 inclusion and 28 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, South Korea, Hungary. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri (time frame: 18 Months). The study lists 2 primary outcomes in all. 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 NCT04903314.

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 31 Mar 2026.

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