Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

NCT06590896 | Recruiting Phase 2

• 2 other identifiers: ONO-2017-02jRCT2031220198
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

Epilepsies, Partial

Outcome Measures

Primary Outcomes (47)

• Incidences of Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

  Through study completion, an average of 4 years

• Urinalysis(pH)

  Measurement of urine pH.

  Through study completion, an average of 4 years

• Urinalysis(Specific Gravity)

  Measurement of urine specific gravity (g/mL).

  Through study completion, an average of 4 years

• Urinalysis(Protein)

  Measurement of urine protein (mg/dL).

  Through study completion, an average of 4 years

• Urinalysis(Glucose)

  Measurement of urine glucose (mg/dL).

  Through study completion, an average of 4 years

• Urinalysis(Ketone)

  Measurement of urine ketone (mg/dL).

  Through study completion, an average of 4 years

• Urinalysis(Bilirubin)

  Measurement of urine bilirubin (mg/dL).

  Through study completion, an average of 4 years

• Urinalysis(Blood)

  Measurement of urine blood (presence/absence).

  Through study completion, an average of 4 years

• Urinalysis(Nitrite)

  Measurement of urine nitrite (presence/absence).

  Through study completion, an average of 4 years

• Urinalysis(Urobilinogen)

  Measurement of urine urobilinogen (mg/dL).

  Through study completion, an average of 4 years

• Urinalysis( Microscopic Examination)

  Microscopic examination of urine (if abnormal).

  Through study completion, an average of 4 years

• Liver function tests(total protein)

  Measurement of total protein(g/dL)

  Through study completion, an average of 4 years

• Liver function tests(albumin)

  Measurement of albumin(g/dL)

  Through study completion, an average of 4 years

• Liver function tests(total bilirubin)

  Measurement of total bilirubin(mg/dL)

  Through study completion, an average of 4 years

• Liver function tests(aspartate transaminase)

  Measurement of aspartate transaminase(U/L)

  Through study completion, an average of 4 years

• Liver function tests(alanine aminotransferase)

  Measurement of alanine aminotransferase(U/L)

  Through study completion, an average of 4 years

• Liver function tests(alkaline phosphatase)

  alkaline phosphatase(U/L)

  Through study completion, an average of 4 years

• Liver function tests(gamma-glutamyl transferase)

  Measurement of gamma-glutamyl transferase(U/L)

  Through study completion, an average of 4 years

• Hematology(Hemoglobin)

  Measurement of hemoglobin(g/dL)

  Through study completion, an average of 4 years

• Hematology(hematocrit)

  Measurement of hematocrit(%)

  Through study completion, an average of 4 years

• Hematology(white blood cell count)

  Measurement of white blood cell count（/μL）

  Through study completion, an average of 4 years

• Hematology(red blood cell count)

  Measurement of red blood cell count（/μL)

  Through study completion, an average of 4 years

• Hematology(mean corpuscular volume)

  Measurement of mean corpuscular volume(fL)

  Through study completion, an average of 4 years

• Hematology(mean corpuscular hemoglobin)

  Measurement of mean corpuscular hemoglobin(pg)

  Through study completion, an average of 4 years

• Hematology(red blood cell distribution width)

  Measurement of red blood cell distribution width(％)

  Through study completion, an average of 4 years

• Hematology(platelet count)

  Measurement of platelet count(/μL)

  Through study completion, an average of 4 years

• Serum chemistry(blood urea nitrogen)

  Measurement of blood urea nitrogen(mg/dL)

  Through study completion, an average of 4 years

• Serum chemistry(calcium)

  Measurement of calcium(mg/dL)

  Through study completion, an average of 4 years

• Serum chemistry(chloride)

  Measurement of chloride(mEq/L)

  Through study completion, an average of 4 years

• Serum chemistry(creatinine)

  Measurement of creatinine(mg/dL)

  Through study completion, an average of 4 years

• Serum chemistry(total bilirubin)

  Measurement of total bilirubin(mg/dL)

  Through study completion, an average of 4 years

• Serum chemistry(direct bilirubin)

  Measurement of direct bilirubin(mg/dL)

  Through study completion, an average of 4 years

• Serum chemistry(alkaline phosphatase)

  Measurement of alkaline phosphatas（U/L）

  Through study completion, an average of 4 years

• Serum chemistry(alanine aminotransferase)

  Measurement of alanine aminotransferase(U/L)

  Through study completion, an average of 4 years

• Serum chemistry(gamma-glutamyl transferase)

  Measurement of gamma-glutamyl transferase(U/L)

  Through study completion, an average of 4 years

• Serum chemistry(total protein)

  Measurement of total protein(g/dL)

  Through study completion, an average of 4 years

• Serum chemistry(albumin)

  Measurement of albumin(g/dL)

  Through study completion, an average of 4 years

• Serum chemistry(globulin)

  Measurement of globulin(g/dL)

  Through study completion, an average of 4 years

• Serum chemistry(sodium)

  Measurement of sodium(mEq/L)

  Through study completion, an average of 4 years

• Serum chemistry(potassium)

  Measurement of potassium(mEq/L)

  Through study completion, an average of 4 years

• Serum chemistry(phosphorus)

  Measurement of phosphorus(mq/dL)

  Through study completion, an average of 4 years

• Serum chemistry(glucose)

  Measurement of glucose(mq/dL)

  Through study completion, an average of 4 years

• Heart rate

  heart rate (beats per minute)

  Through study completion, an average of 4 years

• Respiratory Rate

  Respiratory Rate (breaths per minute),

  Through study completion, an average of 4 years

• Blood Pressure

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

  Through study completion, an average of 4 years

• Electrocardiogram (ECG) Findings

  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.

  Through study completion, an average of 4 years

• Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

  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.

  Through study completion, an average of 4 years

Secondary Outcomes (1)

• Percentage Change in all partial seizure frequency per 28-Day

  Through study completion, an average of 4 years

Study Arms (1)

Cenobamate

EXPERIMENTAL

Drug: Cenobamate

Interventions

Cenobamate DRUG

Cenobamate will be orally administered once daily.

Cenobamate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects completed Study YKP3089C035 by SK Life Science.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (29)

Ehime University Hospital

Ehime, Japan

RECRUITING

Department of Neurology and Stroke Center, Southern Tohoku Clinic.

Fukushima, Japan

RECRUITING

Hiroshima University Hospital

Hiroshima, Japan

RECRUITING

NHO Kure Medical Center and Chugoku Cancer Center

Hiroshima, Japan

RECRUITING

Asahikawa Medical University Hospital

Hokkaido, Japan

RECRUITING

Itami City Hospital

Hyōgo, Japan

RECRUITING

JA-Ibaraki Tsuchiura Kyodo General Hospital

Ibaraki, Japan

RECRUITING

University of Tsukuba Hospital

Ibaraki, Japan

RECRUITING

Kagoshima University Hospital

Kagoshima, Japan

RECRUITING

Tanaka Neurosurgical Clinic

Kagoshima, Japan

RECRUITING

St. Marianna University School of Medicine Hospital

Kanagawa, Japan

RECRUITING

Yokohama City University Hospital

Kanagawa, Japan

RECRUITING

Kumamoto Ezuko Rehabilitation Medical Center

Kumamoto, Japan

RECRUITING

NHO Nagasaki Medical Center

Nagasaki, Japan

RECRUITING

Koide Clinic of Epilepsy and Neurological Disorders

Osaka, Japan

RECRUITING

Osaka University Hospital

Osaka, Japan

RECRUITING

Shintokukai Nii Neurosurgery and Psychiatry Clinic

Osaka, Japan

RECRUITING

Ochiai Brain Clinic

Saitama, Japan

RECRUITING

TMG ASAKA Medical Center

Saitama, Japan

RECRUITING

Sakurai Clinic

Shiga, Japan

RECRUITING

NHO Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Japan

RECRUITING

Seirei Hamamatsu General Hospital

Shizuoka, Japan

RECRUITING

Seirei Mikatahara General Hospital

Shizuoka, Japan

RECRUITING

Jichi Medical University Hospital

Tochigi, Japan

RECRUITING

Tokushima University Hospital

Tokushima, Japan

RECRUITING

Medical Hospital, Tokyo Medical and Dental University

Tokyo, Japan

RECRUITING

National Center of Neurology and Psychiatry

Tokyo, Japan

RECRUITING

Tokyo Medical University Hospital

Tokyo, Japan

RECRUITING

NHO Yamagata National Hospital

Yamagata, Japan

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Cenobamate

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

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

International Clinical Trial Support Desk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: September 19, 2024
• Study Start: November 4, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (29)