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โ† Trials
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ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

RecruitingPhase 3Ages 12 Years - anyAllOno Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent. 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: 1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment. 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.
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What it tests

  • Cenobamate
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Where

25 sites
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
Hyลgo, Japan
Tsuchiura Kyodo General Hospita
Ibaraki, Japan
University of Tsukuba Hospital
Ibaraki, Japan

โ€ฆand 17 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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