Status:
RECRUITING
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Epilepsy, Generalized
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Eligibility Criteria
Inclusion
- Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.
- Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
- Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
- Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens
Exclusion
- Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
- Subject has seizure clusters where individual seizures cannot be counted orclassified.
- History of non-epileptic or psychogenic seizures.
- Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
- 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.
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06579573
Start Date
July 12 2022
End Date
January 31 2027
Last Update
June 17 2025
Active Locations (25)
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1
Aichi Medical University Hospital
Aichi, Japan
2
Hospital of the University of Occupational and Environmental Health, Japan
Fukuoka, Japan
3
Southern TOHOKU Research Institute for Neuroscience Southern TOHOKU Medical Clinic
Fukushima, Japan
4
Local Independent Administrative Corporation Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan