Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Phase 2RecruitingNCT06590896

Ono Pharmaceutical Co., Ltd.100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Epilepsies, Partial

Interventions

CenobamateDRUG

Cenobamate will be orally administered once daily.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (29)

Outcomes

Primary Outcomes

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

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

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

Urinalysis(pH)

Measurement of urine pH.

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

Urinalysis(Specific Gravity)

Measurement of urine specific gravity (g/mL).

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

Urinalysis(Protein)

Measurement of urine protein (mg/dL).

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

Urinalysis(Glucose)

Measurement of urine glucose (mg/dL).

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

Urinalysis(Ketone)

Measurement of urine ketone (mg/dL).

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

Urinalysis(Bilirubin)

Measurement of urine bilirubin (mg/dL).

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

Urinalysis(Blood)

Measurement of urine blood (presence/absence).

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

Urinalysis(Nitrite)

Measurement of urine nitrite (presence/absence).

Central 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 19 more locations

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

Urinalysis(Urobilinogen)

Measurement of urine urobilinogen (mg/dL).

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

Urinalysis( Microscopic Examination)

Microscopic examination of urine (if abnormal).

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

Liver function tests(total protein)

Measurement of total protein(g/dL)

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

Liver function tests(albumin)

Measurement of albumin(g/dL)

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

Liver function tests(total bilirubin)

Measurement of total bilirubin(mg/dL)

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

Liver function tests(aspartate transaminase)

Measurement of aspartate transaminase(U/L)

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

Liver function tests(alanine aminotransferase)

Measurement of alanine aminotransferase(U/L)

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

Liver function tests(alkaline phosphatase)

alkaline phosphatase(U/L)

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

Liver function tests(gamma-glutamyl transferase)

Measurement of gamma-glutamyl transferase(U/L)

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

Hematology(Hemoglobin)

Measurement of hemoglobin(g/dL)

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

Hematology(hematocrit)

Measurement of hematocrit(%)

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

Hematology(white blood cell count)

Measurement of white blood cell count（/μL）

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

Hematology(red blood cell count)

Measurement of red blood cell count（/μL)

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

Hematology(mean corpuscular volume)

Measurement of mean corpuscular volume(fL)

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

Hematology(mean corpuscular hemoglobin)

Measurement of mean corpuscular hemoglobin(pg)

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

Hematology(red blood cell distribution width)

Measurement of red blood cell distribution width(％)

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

Hematology(platelet count)

Measurement of platelet count(/μL)

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

Serum chemistry(blood urea nitrogen)

Measurement of blood urea nitrogen(mg/dL)

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

Serum chemistry(calcium)

Measurement of calcium(mg/dL)

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

Serum chemistry(chloride)

Measurement of chloride(mEq/L)

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

Serum chemistry(creatinine)

Measurement of creatinine(mg/dL)

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

Serum chemistry(total bilirubin)

Measurement of total bilirubin(mg/dL)

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

Serum chemistry(direct bilirubin)

Measurement of direct bilirubin(mg/dL)

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

Serum chemistry(alkaline phosphatase)

Measurement of alkaline phosphatas（U/L）

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

Serum chemistry(alanine aminotransferase)

Measurement of alanine aminotransferase(U/L)

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

Serum chemistry(gamma-glutamyl transferase)

Measurement of gamma-glutamyl transferase(U/L)

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

Serum chemistry(total protein)

Measurement of total protein(g/dL)

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

Serum chemistry(albumin)

Measurement of albumin(g/dL)

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

Serum chemistry(globulin)

Measurement of globulin(g/dL)

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

Serum chemistry(sodium)

Measurement of sodium(mEq/L)

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

Serum chemistry(potassium)

Measurement of potassium(mEq/L)

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

Serum chemistry(phosphorus)

Measurement of phosphorus(mq/dL)

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

Serum chemistry(glucose)

Measurement of glucose(mq/dL)

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

Heart rate

heart rate (beats per minute)

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

Respiratory Rate

Respiratory Rate (breaths per minute),

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

Blood Pressure

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

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

Percentage Change in all partial seizure frequency per 28-Day

It will confirm the frequency of partial seizures at 28-day intervals and calculate the percentage change until the study is completed.

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