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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210624 | Registry Identifier | Japan Registry of Clinical Trials |
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To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenobamate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenobamate | Drug | Cenobamate will be orally administered once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval | Convert the frequency of generalized tonic-clonic seizures (PGTC) in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these. | 12 Weeks of the Maintenance Phase |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in all generalized seizure frequency per 28-Day | Convert the frequency of all generalized seizures in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these. | 12 Weeks of the Maintenance Phase |
| Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval |
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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 |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Recruiting | Aichi | Japan | |||
| Hospital of the University of Occupational and Environmental Health, Japan |
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The percentage of subjects who have a 50%, 75%, 90%, and 100% reduction in all generalized seizure frequency per 28-day interval during the Maintenance Phase relative to the Pre-treatment Phase |
| 12 Weeks of the Maintenance Phase |
| Recruiting |
| Fukuoka |
| Japan |
| Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic | Recruiting | Fukushima | Japan |
| Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital | Recruiting | Hiroshima | Japan |
| Hokkaido University Hospital | Recruiting | Hokkaido | Japan |
| Itami City Hospital | Recruiting | Hyōgo | Japan |
| Tsuchiura Kyodo General Hospita | Recruiting | Ibaraki | Japan |
| University of Tsukuba Hospital | Recruiting | Ibaraki | Japan |
| Kagoshima University Hospital | Recruiting | Kagoshima | Japan |
| SHOWA University Fujigaoka Hospital | Recruiting | Kanagawa | Japan |
| Yokohama City University Hospital | Recruiting | Kanagawa | Japan |
| National Hospital Organization Nishiniigata Chuo Hospital | Recruiting | Niigata | Japan |
| Koide Clinic of Epilepsy and Neurological Disorders | Recruiting | Osaka | Japan |
| TMG Asaka Medical Center | Recruiting | Saitama | Japan |
| NHO Shizuoka Institute of Epilepsy and Neurological Disorder | Recruiting | Shizuoka | Japan |
| Jichi Medical University Hospital | Recruiting | Tochigi | Japan |
| Jikei University Hospital | Recruiting | Tokyo | Japan |
| Maynds Tower Mental Clinic | Recruiting | Tokyo | Japan |
| National Center of Neurology and Psychiatry | Recruiting | Tokyo | Japan |
| Nihonbashi Neuro Clinic | Recruiting | Tokyo | Japan |
| Shinjuku Neuro Clinic | Recruiting | Tokyo | Japan |
| Tokyo Women's Medical University, Adachi Medical Center | Recruiting | Tokyo | Japan |
| Yamaguchi Grand Medical Center | Recruiting | Yamaguchi | Japan |
| University of Yamanashi Hospital | Recruiting | Yamanashi | Japan |
| Yamanashi Prefectural Central Hospital | Recruiting | Yamanashi | Japan |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| 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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