Efficacy and safety of perampanel oral loading in postanoxic super-refractory status epilepticus: A pilot study.
Simone Beretta, Giada Padovano, Andrea Stabile...
https://pubmed.ncbi.nlm.nih.gov/30159874Actively Recruiting
Led by University of California, San Francisco · Updated on 2025-07-08
52
Participants Needed
1
Research Sites
21 weeks
Total Duration
Brain injury is a leading cause of death and disability in patients who survive cardiac arrest, with seizures occurring in up to one-third of these cases. This research investigates the safety and feasibility of using perampanel to prevent post-cardiac arrest status epilepticus (PCARSE), a severe seizure condition following cardiac arrest. The trial is a pilot randomized placebo-controlled study focusing on critically ill patients admitted to intensive care after cardiac arrest. Participants will be randomly assigned to receive either an oral load of 24 mg perampanel followed by 8 mg daily for four more days or a matching placebo following the same schedule, totaling five days of treatment. Perampanel is a non-competitive AMPA glutamate receptor antagonist currently approved for certain seizure types but not yet studied in this specific patient group. The study includes a placebo group for comparison and aims to assess the safety of primary seizure prevention after cardiac arrest. During the study, participants will be closely monitored for safety and tolerability over seven days, with assessments of adverse events and seizure incidence. Researchers will measure seizure frequency, time to seizure control, the number of anti-seizure medications used, and the duration of anesthetic treatment for seizures. Neurological function will be evaluated up to 180 days after treatment. This comprehensive monitoring includes clinical evaluations and safety follow-up to understand perampanel's role in seizure prevention after cardiac arrest.
CONDITIONS
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive an oral load of perampanel or placebo upon randomization followed by daily doses for a total treatment duration of 5 days.
Daily visits or assessments during treatment
Duration - Up to 180 days
Participants are monitored for safety, tolerability, seizure incidence, and neurological function after treatment ends.
Assessments at 7 days and 180 days post-treatment
Total: 1 location
1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
E
Edilberto Amorim, MD
K
Kevin Bao, BA
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Simone Beretta, Giada Padovano, Andrea Stabile...
https://pubmed.ncbi.nlm.nih.gov/30159874Lawrence J Hirsch, Michael W K Fong, Markus Leitinger...
https://pubmed.ncbi.nlm.nih.gov/33475321