This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period in untreated participants with partial onset seizures (POS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Oral tablet
Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel.
Time frame: 26 weeks in Maintenance Period of 4 mg perampanel
Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel.
Time frame: 26 weeks in Maintenance Period of 4 or 8 mg perampanel
Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of 4 mg of Perampanel
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks treatment of 4 mg perampanel.
Time frame: 52-week (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel)
Percentage of Participants With POS Who Achieved Seizure-free Status During the 52-week of Treatment Phase (26-week Maintenance Period Plus 26-week Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel
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Eisai Trial Site #18
Aichi, Japan
Eisai Trial Site #19
Aichi, Japan
Eisai Trial Site #11
Fukuoka, Japan
Eisai Trial Site #29
Fukuoka, Japan
Eisai Trial Site #4
Hiroshima, Japan
Eisai Trial Site #16
Hokkaido, Japan
Eisai Trial Site #8
Hokkaido, Japan
Eisai Trial Site #14
Hyōgo, Japan
Eisai Trial Site #6
Hyōgo, Japan
Eisai Trial Site #7
Kagoshima, Japan
...and 28 more locations
A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during the 52-week treatment of last evaluated dose of 4 or 8 mg perampanel.
Time frame: 52-week (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel)
Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel
Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.
Time frame: From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)
Time to Onset of First Seizure From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.
Time frame: From the first dose of study drug in the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)
Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of 4 mg Perampanel
Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason.
Time frame: From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)
Time to Withdrawal From the First Dose of Study Drug in the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel
Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg or 8 mg Maintenance Period to the date of withdrawal from study, regardless of reason.
Time frame: From the first dose of study drug in the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug
Time frame: From baseline up to 28 days after last dose of study drug (up to 160 weeks)