A Study of Intravenous Perampanel in Japanese Participants With Epilepsy (NCT03754582) | Clinical Trial Compass
CompletedPhase 2
A Study of Intravenous Perampanel in Japanese Participants With Epilepsy
Japan21 participantsStarted 2018-11-27
Plain-language summary
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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. A diagnosis of epilepsy with POS (including secondarily generalized seizures) or PGTC seizures according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981).
✓. Receiving a stable dose regimen of oral perampanel.
✓. Receiving a concomitant stable dose regimen of marketed AEDs. No change of dosing regimen for concomitant AEDs is planned during the intravenous Treatment and Follow-up Phases.
✓. Considered reliable and willing to be available for the study period by the investigator, and are able to record seizures and report AEs by themselves or have a caregiver who can record seizures and report AEs for them.
Exclusion criteria
✕. A history of drug or alcohol dependency or abuse.
✕. A history of status epilepticus.
✕. Unsuitable for venipuncture and intravenous administration.
✕. Requires medical intervention due to safety issues related to concomitant administration of AEDs.
✕. A history of suicidal ideation/attempt.
✕. Clinical symptoms or imaging suggest progressive central nervous system (CNS) abnormality, disorder, or brain tumor.
✕. Current evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigators could affect the participant's safety, interfere with the study assessments or need prohibited medications as specified in the study protocol.
What they're measuring
1
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: 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)
2
Number of Participants With Adverse Events (AEs)
Timeframe: 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)
3
Number of Participants With Markedly Abnormal Clinical Laboratory Parameter Values During Treatment and Follow-up Phase
Timeframe: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after last dose)
4
Number of Participants With Abnormal Vital Sign Values During Treatment and Follow-up Phase
Timeframe: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
5
Number of Participants With Abnormal Body Weight During Treatment and Follow-up Phase
Timeframe: Up to 11 days (Treatment Phase: up to 4 days, Follow-up Phase: up to 7 days after the last dose)
6
Number of Participants With Clinically Significant Markedly Abnormal Electrocardiogram (ECG) Value During Treatment and Follow-up Phase
Timeframe: Up to Day 11 (Treatment Phase: at Day 4, Follow-up Phase: up to 7 days after the last dose)