This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
film-coated tablets
The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Arkansas Epilepsy Program
Little Rock, Arkansas, United States
UCSD Epilepsy Center
La Jolla, California, United States
Stanford Medical Center
Palo Alto, California, United States
UC Davis Medical Center
Sacramento, California, United States
Baptist Health, Nemours Children's Specialty Care
Jacksonville, Florida, United States
RUSH University Medical Center
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
...and 14 more locations
Percentage of Participants Remaining on Perampanel Treatment at 3 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 3 months after the initiation of treatment.
Time frame: Month 3
Percentage of Participants Remaining on Perampanel Treatment at 6 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
Time frame: Month 6
Percentage of Participants Remaining on Perampanel Treatment at 9 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 9 months after the initiation of treatment.
Time frame: Month 9
Percentage of Participants Remaining on Perampanel Treatment at 12 Months After the Initiation of Treatment
The retention rate was defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
Time frame: Month 12
Percentage of Participants Who Achieved Seizure-free Status During the Maintenance Period
Seizure-free status was defined as no incidence of seizure during the entire maintenance period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participants does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Time frame: Up to 39 weeks of Maintenance Period
Percentage of Participants Who Achieved 3-month Seizure-free Status During the Maintenance Period
Seizure-free status was defined as no incidence of seizure at 3 months during the Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Time frame: Up to 3 months of Maintenance Period
Percentage of Participants Who Achieved 6-month Seizure-free Status During the Maintenance Period
Seizure-free status was defined as no incidence of seizure at 6 months during Maintenance Period. Partial seizures: when abnormal electrical activity begins in only one part of brain include (1) simple partial seizures: participant does not lose consciousness may experience muscle jerking or stiffening, (2) complex partial seizures: participant loses awareness. SGS: disturbances that spread to both sides of brain after partial seizure has already begun and happen when burst of electrical activity in limited area (the partial seizure) spreads throughout brain. PGTCS: disturbances in functioning of both sides of brain that caused by electrical signals spreading through brain inappropriately.
Time frame: Up to 6 months of Maintenance Period
Percentage of Participants Who Received Perampanel as a First Adjunctive Therapy and Converted to Perampanel Monotherapy
Percentage of participants who received perampanel as a first adjunctive therapy and converted to perampanel monotherapy were reported.
Time frame: Up to 52 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAE)
A TEAE was defined as an adverse event (AE) that emerged during treatment, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous.
Time frame: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)
Number of Participants With Treatment-emergent Serious Adverse Events (SAE)
A SAE was defined as any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect. A TEAE was defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Time frame: From date of first administration of study drug up to 28 days after last dose of study drug (up to 56 weeks)
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