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 range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.