Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06590896

Enrollment

100

Registered

2024-09-19

Start date

2022-11-04

Completion date

2027-01-31

Last updated

2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial

Brief summary

To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures

Interventions

DRUGCenobamate

Cenobamate will be orally administered once daily.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Subjects completed Study YKP3089C035 by SK Life Science.

Exclusion criteria

* Subjects that have previously discontinued for any reason from the Core study (YKP3089C035). * Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.

Design outcomes

Primary

Measure	Time frame	Description
Columbia-Suicide Severity Rating Scale (C-SSRS) Scores	Through study completion, an average of 4 years	Scores on the Columbia-Suicide Severity Rating Scale (C-SSRS) will be recorded. Questions regarding suicide are recorded as yes or no, and the percentage of subject with suicide risk (yes) is assessed.
Hematology(platelet count)	Through study completion, an average of 4 years	Measurement of platelet count(/μL)
Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Through study completion, an average of 4 years	The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.
Urinalysis(pH)	Through study completion, an average of 4 years	Measurement of urine pH.
Urinalysis(Specific Gravity)	Through study completion, an average of 4 years	Measurement of urine specific gravity (g/mL).
Urinalysis(Protein)	Through study completion, an average of 4 years	Measurement of urine protein (mg/dL).
Urinalysis(Glucose)	Through study completion, an average of 4 years	Measurement of urine glucose (mg/dL).
Urinalysis(Ketone)	Through study completion, an average of 4 years	Measurement of urine ketone (mg/dL).
Urinalysis(Bilirubin)	Through study completion, an average of 4 years	Measurement of urine bilirubin (mg/dL).
Urinalysis(Blood)	Through study completion, an average of 4 years	Measurement of urine blood (presence/absence).
Urinalysis(Nitrite)	Through study completion, an average of 4 years	Measurement of urine nitrite (presence/absence).
Urinalysis(Urobilinogen)	Through study completion, an average of 4 years	Measurement of urine urobilinogen (mg/dL).
Urinalysis( Microscopic Examination)	Through study completion, an average of 4 years	Microscopic examination of urine (if abnormal).
Liver function tests(total protein)	Through study completion, an average of 4 years	Measurement of total protein(g/dL)
Liver function tests(albumin)	Through study completion, an average of 4 years	Measurement of albumin(g/dL)
Liver function tests(total bilirubin)	Through study completion, an average of 4 years	Measurement of total bilirubin(mg/dL)
Liver function tests(aspartate transaminase)	Through study completion, an average of 4 years	Measurement of aspartate transaminase(U/L)
Liver function tests(alanine aminotransferase)	Through study completion, an average of 4 years	Measurement of alanine aminotransferase(U/L)
Liver function tests(alkaline phosphatase)	Through study completion, an average of 4 years	alkaline phosphatase(U/L)
Liver function tests(gamma-glutamyl transferase)	Through study completion, an average of 4 years	Measurement of gamma-glutamyl transferase(U/L)
Hematology(Hemoglobin)	Through study completion, an average of 4 years	Measurement of hemoglobin(g/dL)
Hematology(hematocrit)	Through study completion, an average of 4 years	Measurement of hematocrit(%)
Hematology(white blood cell count)	Through study completion, an average of 4 years	Measurement of white blood cell count（/μL）
Hematology(red blood cell count)	Through study completion, an average of 4 years	Measurement of red blood cell count（/μL)
Hematology(mean corpuscular volume)	Through study completion, an average of 4 years	Measurement of mean corpuscular volume(fL)
Hematology(mean corpuscular hemoglobin)	Through study completion, an average of 4 years	Measurement of mean corpuscular hemoglobin(pg)
Hematology(red blood cell distribution width)	Through study completion, an average of 4 years	Measurement of red blood cell distribution width(％)
Serum chemistry(blood urea nitrogen)	Through study completion, an average of 4 years	Measurement of blood urea nitrogen(mg/dL)
Serum chemistry(calcium)	Through study completion, an average of 4 years	Measurement of calcium(mg/dL)
Serum chemistry(chloride)	Through study completion, an average of 4 years	Measurement of chloride(mEq/L)
Serum chemistry(creatinine)	Through study completion, an average of 4 years	Measurement of creatinine(mg/dL)
Serum chemistry(total bilirubin)	Through study completion, an average of 4 years	Measurement of total bilirubin(mg/dL)
Serum chemistry(direct bilirubin)	Through study completion, an average of 4 years	Measurement of direct bilirubin(mg/dL)
Serum chemistry(alkaline phosphatase)	Through study completion, an average of 4 years	Measurement of alkaline phosphatas（U/L）
Serum chemistry(alanine aminotransferase)	Through study completion, an average of 4 years	Measurement of alanine aminotransferase(U/L)
Serum chemistry(gamma-glutamyl transferase)	Through study completion, an average of 4 years	Measurement of gamma-glutamyl transferase(U/L)
Serum chemistry(total protein)	Through study completion, an average of 4 years	Measurement of total protein(g/dL)
Serum chemistry(albumin)	Through study completion, an average of 4 years	Measurement of albumin(g/dL)
Serum chemistry(globulin)	Through study completion, an average of 4 years	Measurement of globulin(g/dL)
Serum chemistry(sodium)	Through study completion, an average of 4 years	Measurement of sodium(mEq/L)
Serum chemistry(potassium)	Through study completion, an average of 4 years	Measurement of potassium(mEq/L)
Serum chemistry(phosphorus)	Through study completion, an average of 4 years	Measurement of phosphorus(mq/dL)
Serum chemistry(glucose)	Through study completion, an average of 4 years	Measurement of glucose(mq/dL)
Heart rate	Through study completion, an average of 4 years	heart rate (beats per minute)
Respiratory Rate	Through study completion, an average of 4 years	Respiratory Rate (breaths per minute),
Blood Pressure	Through study completion, an average of 4 years	blood pressure, both of systolic and diastolic (mm Hg)
Electrocardiogram (ECG) Findings	Through study completion, an average of 4 years	ECG findings, including heart rate (beats per minute), PR Interval (milliseconds), PQ Interval (milliseconds), RR Interval (milliseconds), QRS Interval (milliseconds), and QT Interval (milliseconds), will be recorded.

Secondary

Measure	Time frame	Description
Percentage Change in all partial seizure frequency per 28-Day	Through study completion, an average of 4 years	It will confirm the frequency of partial seizures at 28-day intervals and calculate the percentage change until the study is completed.

Countries

Japan

Contacts

Primary ContactNorth America Clinical Trial Support Desk

clinical_trial@ono-pharma.com+18665877745(Toll-Free)

Backup ContactInternational Clinical Trial Support Desk

clinical_trial@ono-pharma.com+17162141777(Standard)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026