ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
NCT ID: NCT06579573
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
15 participants
INTERVENTIONAL
2022-07-12
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cenobamate
Cenobamate
Cenobamate will be orally administered once daily.
Interventions
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Cenobamate
Cenobamate will be orally administered once daily.
Eligibility Criteria
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Inclusion Criteria
2. Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
3. Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
4. Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens
Exclusion Criteria
2. Subject has seizure clusters where individual seizures cannot be counted orclassified.
3. History of non-epileptic or psychogenic seizures.
4. Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
5. Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.
12 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Aichi Medical University Hospital
Aichi, , Japan
Hospital of the University of Occupational and Environmental Health, Japan
Fukuoka, , Japan
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Fukushima, , Japan
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Itami City Hospital
Hyōgo, , Japan
Tsuchiura Kyodo General Hospita
Ibaraki, , Japan
University of Tsukuba Hospital
Ibaraki, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
SHOWA University Fujigaoka Hospital
Kanagawa, , Japan
Yokohama City University Hospital
Kanagawa, , Japan
National Hospital Organization Nishiniigata Chuo Hospital
Niigata, , Japan
Koide Clinic of Epilepsy and Neurological Disorders
Osaka, , Japan
TMG Asaka Medical Center
Saitama, , Japan
NHO Shizuoka Institute of Epilepsy and Neurological Disorder
Shizuoka, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Jikei University Hospital
Tokyo, , Japan
Maynds Tower Mental Clinic
Tokyo, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Nihonbashi Neuro Clinic
Tokyo, , Japan
Shinjuku Neuro Clinic
Tokyo, , Japan
Tokyo Women's Medical University, Adachi Medical Center
Tokyo, , Japan
Yamaguchi Grand Medical Center
Yamaguchi, , Japan
University of Yamanashi Hospital
Yamanashi, , Japan
Yamanashi Prefectural Central Hospital
Yamanashi, , Japan
Countries
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Central Contacts
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Other Identifiers
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jRCT2031210624
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-2017-01
Identifier Type: -
Identifier Source: org_study_id
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