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NCT Number: NCT06590896

Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

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

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Key information

Conditions

Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ehime University Hospital, Ehime, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cenobamate

Drug

Cenobamate will be orally administered once daily.

Primary outcomes

  1. Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Through study completion, an average of 4 years

    The incidences of adverse events (AEs) and serious adverse events (SAEs) will be recorded.

  2. Urinalysis(pH)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine pH.

  3. Urinalysis(Specific Gravity)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine specific gravity (g/mL).

  4. Urinalysis(Protein)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine protein (mg/dL).

  5. Urinalysis(Glucose)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine glucose (mg/dL).

  6. Urinalysis(Ketone)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine ketone (mg/dL).

  7. Urinalysis(Bilirubin)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine bilirubin (mg/dL).

  8. Urinalysis(Blood)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine blood (presence/absence).

  9. Urinalysis(Nitrite)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine nitrite (presence/absence).

  10. Urinalysis(Urobilinogen)

    Time frame: Through study completion, an average of 4 years

    Measurement of urine urobilinogen (mg/dL).

  11. Urinalysis( Microscopic Examination)

    Time frame: Through study completion, an average of 4 years

    Microscopic examination of urine (if abnormal).

  12. Liver function tests(total protein)

    Time frame: Through study completion, an average of 4 years

    Measurement of total protein(g/dL)

  13. Liver function tests(albumin)

    Time frame: Through study completion, an average of 4 years

    Measurement of albumin(g/dL)

  14. Liver function tests(total bilirubin)

    Time frame: Through study completion, an average of 4 years

    Measurement of total bilirubin(mg/dL)

  15. Liver function tests(aspartate transaminase)

    Time frame: Through study completion, an average of 4 years

    Measurement of aspartate transaminase(U/L)

  16. Liver function tests(alanine aminotransferase)

    Time frame: Through study completion, an average of 4 years

    Measurement of alanine aminotransferase(U/L)

  17. Liver function tests(alkaline phosphatase)

    Time frame: Through study completion, an average of 4 years

    alkaline phosphatase(U/L)

  18. Liver function tests(gamma-glutamyl transferase)

    Time frame: Through study completion, an average of 4 years

    Measurement of gamma-glutamyl transferase(U/L)

  19. Hematology(Hemoglobin)

    Time frame: Through study completion, an average of 4 years

    Measurement of hemoglobin(g/dL)

  20. Hematology(hematocrit)

    Time frame: Through study completion, an average of 4 years

    Measurement of hematocrit(%)

  21. Hematology(white blood cell count)

    Time frame: Through study completion, an average of 4 years

    Measurement of white blood cell count（/μL）

  22. Hematology(red blood cell count)

    Time frame: Through study completion, an average of 4 years

    Measurement of red blood cell count（/μL)

  23. Hematology(mean corpuscular volume)

    Time frame: Through study completion, an average of 4 years

    Measurement of mean corpuscular volume(fL)

  24. Hematology(mean corpuscular hemoglobin)

    Time frame: Through study completion, an average of 4 years

    Measurement of mean corpuscular hemoglobin(pg)

  25. Hematology(red blood cell distribution width)

    Time frame: Through study completion, an average of 4 years

    Measurement of red blood cell distribution width(％)

  26. Hematology(platelet count)

    Time frame: Through study completion, an average of 4 years

    Measurement of platelet count(/μL)

  27. Serum chemistry(blood urea nitrogen)

    Time frame: Through study completion, an average of 4 years

    Measurement of blood urea nitrogen(mg/dL)

  28. Serum chemistry(calcium)

    Time frame: Through study completion, an average of 4 years

    Measurement of calcium(mg/dL)

  29. Serum chemistry(chloride)

    Time frame: Through study completion, an average of 4 years

    Measurement of chloride(mEq/L)

  30. Serum chemistry(creatinine)

    Time frame: Through study completion, an average of 4 years

    Measurement of creatinine(mg/dL)

  31. Serum chemistry(total bilirubin)

    Time frame: Through study completion, an average of 4 years

    Measurement of total bilirubin(mg/dL)

  32. Serum chemistry(direct bilirubin)

    Time frame: Through study completion, an average of 4 years

    Measurement of direct bilirubin(mg/dL)

  33. Serum chemistry(alkaline phosphatase)

    Time frame: Through study completion, an average of 4 years

    Measurement of alkaline phosphatas（U/L）

  34. Serum chemistry(alanine aminotransferase)

    Time frame: Through study completion, an average of 4 years

    Measurement of alanine aminotransferase(U/L)

  35. Serum chemistry(gamma-glutamyl transferase)

    Time frame: Through study completion, an average of 4 years

    Measurement of gamma-glutamyl transferase(U/L)

  36. Serum chemistry(total protein)

    Time frame: Through study completion, an average of 4 years

    Measurement of total protein(g/dL)

  37. Serum chemistry(albumin)

    Time frame: Through study completion, an average of 4 years

    Measurement of albumin(g/dL)

  38. Serum chemistry(globulin)

    Time frame: Through study completion, an average of 4 years

    Measurement of globulin(g/dL)

  39. Serum chemistry(sodium)

    Time frame: Through study completion, an average of 4 years

    Measurement of sodium(mEq/L)

  40. Serum chemistry(potassium)

    Time frame: Through study completion, an average of 4 years

    Measurement of potassium(mEq/L)

  41. Serum chemistry(phosphorus)

    Time frame: Through study completion, an average of 4 years

    Measurement of phosphorus(mq/dL)

  42. Serum chemistry(glucose)

    Time frame: Through study completion, an average of 4 years

    Measurement of glucose(mq/dL)

  43. Heart rate

    Time frame: Through study completion, an average of 4 years

    heart rate (beats per minute)

  44. Respiratory Rate

    Time frame: Through study completion, an average of 4 years

    Respiratory Rate (breaths per minute),

  45. Blood Pressure

    Time frame: Through study completion, an average of 4 years

    blood pressure, both of systolic and diastolic (mm Hg)

  46. Electrocardiogram (ECG) Findings

    Time frame: 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.

  47. Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

    Time frame: 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.

Secondary outcomes

  1. Percentage Change in all partial seizure frequency per 28-Day

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

International Clinical Trial Support Desk

CONTACT

[email protected]

+17162141777(Standard)

North America Clinical Trial Support Desk

CONTACT

[email protected]

+18665877745(Toll-Free)

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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