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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031220198 | Registry Identifier | Japan Registry of Clinical Trials |
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To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenobamate | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenobamate | Drug | Cenobamate will be orally administered once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ehime University Hospital | Recruiting | Ehime | Japan | |||
| Department of Neurology and Stroke Center, Southern Tohoku Clinic. |
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| 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 |
| Recruiting |
| Fukushima |
| Japan |
| Hiroshima University Hospital | Recruiting | Hiroshima | Japan |
| NHO Kure Medical Center and Chugoku Cancer Center | Recruiting | Hiroshima | Japan |
| Asahikawa Medical University Hospital | Recruiting | Hokkaido | Japan |
| Itami City Hospital | Recruiting | Hyōgo | Japan |
| JA-Ibaraki Tsuchiura Kyodo General Hospital | Recruiting | Ibaraki | Japan |
| University of Tsukuba Hospital | Recruiting | Ibaraki | Japan |
| Kagoshima University Hospital | Recruiting | Kagoshima | Japan |
| Tanaka Neurosurgical Clinic | Recruiting | Kagoshima | Japan |
| St. Marianna University School of Medicine Hospital | Recruiting | Kanagawa | Japan |
| Yokohama City University Hospital | Recruiting | Kanagawa | Japan |
| Kumamoto Ezuko Rehabilitation Medical Center | Recruiting | Kumamoto | Japan |
| NHO Nagasaki Medical Center | Recruiting | Nagasaki | Japan |
| Koide Clinic of Epilepsy and Neurological Disorders | Recruiting | Osaka | Japan |
| Osaka University Hospital | Recruiting | Osaka | Japan |
| Shintokukai Nii Neurosurgery and Psychiatry Clinic | Recruiting | Osaka | Japan |
| Ochiai Brain Clinic | Recruiting | Saitama | Japan |
| TMG ASAKA Medical Center | Recruiting | Saitama | Japan |
| Sakurai Clinic | Recruiting | Shiga | Japan |
| NHO Shizuoka Institute of Epilepsy and Neurological Disorders | Recruiting | Shizuoka | Japan |
| Seirei Hamamatsu General Hospital | Recruiting | Shizuoka | Japan |
| Seirei Mikatahara General Hospital | Recruiting | Shizuoka | Japan |
| Jichi Medical University Hospital | Recruiting | Tochigi | Japan |
| Tokushima University Hospital | Recruiting | Tokushima | Japan |
| Medical Hospital, Tokyo Medical and Dental University | Recruiting | Tokyo | Japan |
| National Center of Neurology and Psychiatry | Recruiting | Tokyo | Japan |
| Tokyo Medical University Hospital | Recruiting | Tokyo | Japan |
| NHO Yamagata National Hospital | Recruiting | Yamagata | Japan |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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