Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06401707

Perampanel for Status Epilepticus Prevention After Cardiac Arrest

Led by University of California, San Francisco · Updated on 2025-07-08

52

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Experienced non-traumatic cardiac arrest outside the hospital
  • Comatose upon admission, defined as not following commands
  • Return of spontaneous circulation within 45 minutes from cardiac arrest
  • Admitted to the intensive care unit at Zuckerberg San Francisco General Hospital
Not Eligible

You will not qualify if you...

  • Acute cerebral hemorrhage or infarction
  • Pregnancy
  • Prisoner status
  • Severe kidney impairment with creatinine clearance below 30 ml/min
  • Severe liver impairment with liver tests five times above normal
  • Diagnosis of electrographic or electroclinical seizures confirmed after cardiac arrest

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Zuckerberg San Francisco General Hospital

San Francisco, California, United States, 94110

Actively Recruiting

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Research Team

E

Edilberto Amorim, MD

K

Kevin Bao, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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/30159874