Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
- Registration Number
- NCT06590896
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Subjects completed Study YKP3089C035 by SK Life Science.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cenobamate Cenobamate -
- Primary Outcome Measures
Name Time Method 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(％)
Hematology(platelet count) Through study completion, an average of 4 years Measurement of platelet count(/μL)
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (29)
Ehime University Hospital
🇯🇵Ehime, Japan
Department of Neurology and Stroke Center, Southern Tohoku Clinic.
🇯🇵Fukushima, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
NHO Kure Medical Center and Chugoku Cancer Center
🇯🇵Hiroshima, Japan
Asahikawa Medical University Hospital
🇯🇵Hokkaido, Japan
Itami City Hospital
🇯🇵Hyōgo, Japan
JA-Ibaraki Tsuchiura Kyodo General Hospital
🇯🇵Ibaraki, Japan
University of Tsukuba Hospital
🇯🇵Ibaraki, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Tanaka Neurosurgical Clinic
🇯🇵Kagoshima, Japan
St. Marianna University School of Medicine Hospital
🇯🇵Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Kanagawa, Japan
Kumamoto Ezuko Rehabilitation Medical Center
🇯🇵Kumamoto, Japan
NHO Nagasaki Medical Center
🇯🇵Nagasaki, Japan
Koide Clinic of Epilepsy and Neurological Disorders
🇯🇵Osaka, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Shintokukai Nii Neurosurgery and Psychiatry Clinic
🇯🇵Osaka, Japan
Ochiai Brain Clinic
🇯🇵Saitama, Japan
TMG ASAKA Medical Center
🇯🇵Saitama, Japan
Sakurai Clinic
🇯🇵Shiga, Japan
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
🇯🇵Shizuoka, Japan
Seirei Hamamatsu General Hospital
🇯🇵Shizuoka, Japan
Seirei Mikatahara General Hospital
🇯🇵Shizuoka, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Japan
Tokushima University Hospital
🇯🇵Tokushima, Japan
Medical Hospital, Tokyo Medical and Dental University
🇯🇵Tokyo, Japan
National Center of Neurology and Psychiatry
🇯🇵Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
NHO Yamagata National Hospital
🇯🇵Yamagata, Japan