The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS).
The study will consist of a Core Study (36 weeks) and an Extension Phase (24 weeks). Core Study will consist of 4 weeks Pre-treatment Phase or Baseline and 32 weeks Treatment Phase (8 weeks Titration period and 24 weeks Maintenance period).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Perampanel tablets.
Eisai Site #9
Cheongju-si, South Korea
Eisai Site #4
Daegu, South Korea
Eisai Site #8
Daegu, South Korea
Eisai Site #3
Daejeon, South Korea
Percentage of Participants Who Will Achieve Seizure Freedom During the 24-weeks Maintenance Period
Time frame: Up to 24 weeks
Percentage of Participants Who Will Achieve Seizure Freedom During the Total 48-weeks Treatment Period (24-weeks Maintenance Period Plus 24-weeks Extension Phase)
Time frame: Up to 48 weeks
Percentage of Participants With at Least 50 Percent (%) and 75% Reduction in Seizure Frequency During the 24-weeks Maintenance Period
50% responder rate is defined as the percentage of participants with greater than or equal to (\>=) 50% reduction in seizure frequency. 75% responder rate is defined as the percentage of participants with \>=75% reduction in seizure frequency.
Time frame: Up to 24 weeks
Percentage of Participants With at Least 50% and 75% Reduction in Seizure Frequency During the 24-weeks Extension Phase
50% responder rate is defined as the percentage of participants with \>=50% reduction in seizure frequency. 75% responder rate is defined as the percentage of participants with \>=75% reduction in seizure frequency.
Time frame: Up to 24 weeks
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 Days at the End of 8 Weeks Titration Period
Time frame: Baseline up to Week 8 of Titration Period
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Maintenance Period
Time frame: Baseline up to Week 24 of Maintenance Period
Median Percent Change From Baseline in Partial Onset Seizure Frequency per 28 days at the End of 24 Weeks Extension Phase
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Eisai Site #10
Jeonju, South Korea
Eisai Site #1
Seoul, South Korea
Eisai Site #2
Seoul, South Korea
Eisai Site #5
Seoul, South Korea
Eisai Site #6
Seoul, South Korea
Eisai Site #7
Seoul, South Korea
Time frame: Baseline up to Week 24 of Extension Phase
Percentage of Participants Remaining on Perampanel Treatment at the end of Maintenance Period
The retention rate is defined as the percentage of participants remaining on perampanel treatment at the end of Maintenance Period after initiating treatment.
Time frame: Week 24 of Maintenance Period
Percentage of Participants Remaining on Perampanel Treatment at the end of Extension Phase
The retention rate is defined as the percentage of participants remaining on perampanel treatment at the end of Extension Phase after initiating treatment.
Time frame: Week 24 of Extension Phase
Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. An AE is defined as any untoward medical occurrence in a participant administered an investigational product. An AE does not necessarily have a causal relationship with a medicinal product.
Time frame: Up to 60 weeks
Number of Participants With Abnormal Vital Sign Values
Vital sign parameters will include diastolic and systolic blood pressure (BP), pulse rate, respiratory rate, body temperature and body weight.
Time frame: Up to 60 weeks
Number of Participants With Clinically Significant Laboratory Values
Laboratory parameters will include hematology and blood chemistry.
Time frame: Up to 60 weeks