RecruitingPhase 2NCT06401707

PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest


Sponsor

University of California, San Francisco

Enrollment

52 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. The investigators are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for post-cardiac arrest status epilepticus (PCARSE) prevention after cardiac arrest.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Age ≥18 years old
  • Non-traumatic, out-of-hospital cardiac arrest
  • Comatose on admission - defined as not following commands
  • Return of spontaneous circulation (ROSC) within less than 45 minutes from the time of cardiac arrest (defined as the time of 911 or EMS (emergency medical services) witnessed arrest)
  • Admission to the intensive care unit at Zuckerberg San Francisco General Hospital

Exclusion Criteria6

  • Acute cerebral hemorrhage or infarction
  • Pregnancy
  • Prisoner
  • Severe kidney function impairment with creatinine clearance inferior to 30 ml/min
  • Severe liver impairment with liver function tests five times above the upper limit of normal
  • Electrographic or electroclinical seizures diagnosis using American Clinical Neurophysiology criteria confirmed by an epileptologist after cardiac arrest

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Interventions

DRUGPerampanel

Perampanel is a non-competitive AMPA glutamate receptor antagonist.

DRUGPlacebo

Placebo


Locations(1)

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

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NCT06401707


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