The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per day \[mg/day\]) as an adjunctive therapy in participants with epilepsy with partial onset seizures (POS) (including secondarily generalized seizures) or primary generalized tonic-clonic (PGTC) seizures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Oral tablets.
Intravenous infusion.
Eisai trial site 5
Kurume, Fukuoka, Japan
Eisai trial site 12
Sapporo, Hokkaido, Japan
Eisai trial site 9
Ōmura, Nagasaki, Japan
Eisai trial site 7
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product, any new disease or exacerbation of an existing disease, any deterioration in nonprotocol-required measurements of a laboratory value or other clinical test that resulted in symptoms, a change in treatment, or discontinuation of study drug, recurrence of an intermittent medical condition not present pretreatment, an abnormal laboratory test result was considered an AE if the identified laboratory abnormality led to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not.
Time frame: Up to 60 days (Pretreatment Phase: up to 28 days, Treatment Phase: up to 4 days, Follow-up Phase: up to 28 days after last dose)
Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase
Time frame: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)
Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase
Time frame: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
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Sayama, Osaka, Japan
Eisai trial site 2
Asaka, Saitama, Japan
Eisai trial site 13
Hamamatsu, Shizuoka, Japan
Eisai trial site 8
Kodaira, Tokyo, Japan
Eisai trial site 10
Hiroshima, Japan
Eisai trial site 6
Kagoshima, Japan
Eisai trial site 1
Niigata, Japan
...and 3 more locations
Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase
Time frame: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase
Time frame: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)
Mean Seizure Frequency Per Day in Pretreatment Phase, Treatment Phase and Follow-up Phase
Seizure frequency was based on number of seizures per day, calculated as the number of seizures over the entire time interval divided by the number of days in the interval.
Time frame: Up to 39 days (Pretreatment Phase: up to 28 days; Treatment Phase: up to 4 days; Follow-up Phase: up to 7 days after the last dose)
Plasma Concentration of Perampanel Before and After Switching From Oral Perampanel to 30-minute Intravenous Infusions of Perampanel
Time frame: Pretreatment Phase-Day -1: Pre-dose, 0.5 hours, 1 hours and 1.5 hours post-dose; Treatment Phase-Day 1, Day 2, Day 3 and Day 4: Pre-dose and 0.5 hours after start of intravenous infusions