To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Cenobamate will be orally administered once daily.
Aichi Medical University Hospital
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.
Time frame: 12 Weeks of the Maintenance Phase
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.
Time frame: 12 Weeks of the Maintenance Phase
Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval
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
Time frame: 12 Weeks of the Maintenance Phase
North America Clinical Trial Support Desk
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Aichi, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Fukuoka, Japan
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