PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perampanel, Placebo.
- Who it may be relevant to
- Registry conditions: Heart Arrest, Seizures, Status Epilepticus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
More than 500,000 Americans have a cardiac arrest every year and 100,000 survive to hospital admission. 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. Seizures with or without muscle jerks, i.e. myoclonic seizures, are the most common seizure type after a cardiac arrest. Despite being common, seizures are usually refractory to treatment (post-cardiac arrest refractory status epilepticus) and the vast majority of patients with this diagnosis die. We are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for PCARSE prevention after cardiac arrest. Perampanel is a non-competitive AMPA glutamate receptor antagonist approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures, however there are no randomized trials in critically ill cardiac arrest patients at risk for seizures. This medication has been used for the management of refractory status epilepticus, including status epilepticus post-cardiac arrest. We will randomize patients to placebo or perampanel after admission to the intensive care unit. The study's primary outcome will be the incidence of severe adverse events. Secondary efficacy and safety endpoints include incidence of seizures and PCARSE, seizure frequency, time to seizure control, number of anti-seizure medications necessary for seizure control, duration of treatment with anesthetics for seizure control, and time to coma awakening. This study will help determine the safety and feasibility of primary seizure prophylaxis after cardiac arrest.
Interventions
- Drug Perampanel
Perampanel is a non-competitive AMPA glutamate receptor antagonist. - Drug Placebo
Placebo
Primary outcome measures
- Safety and tolerability of perampanel [Time frame: 7 days]
- Adverse and Serious Adverse Events [Time frame: 7 days]
Secondary outcome measures (5)
- Incidence of post-cardiac arrest refractory status epilepticus [Time frame: 7 days]
- Incidence of post-cardiac arrest seizures [Time frame: 7 days]
- Treatment intensity of post-cardiac arrest refractory status epilepticus [Time frame: 7 days]
- Time to start of post-cardiac arrest refractory status epilepticus [Time frame: 7 days]
- Neurological function at 180 days [Time frame: 180 days]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Zuckerberg San Francisco General Hospital — San Francisco
Publications
- Beretta S, Padovano G, Stabile A, Coppo A, Bogliun G, Avalli L, Ferrarese C. Efficacy and safety of perampanel oral loading in postanoxic super-refractory status epilepticus: A pilot study. Epilepsia. 2018 Oct;59 Suppl 2:243-248. doi: 10.1111/epi.14492. Epub 2018 Aug 29. PMID 30159874
- Hirsch LJ, Fong MWK, Leitinger M, LaRoche SM, Beniczky S, Abend NS, Lee JW, Wusthoff CJ, Hahn CD, Westover MB, Gerard EE, Herman ST, Haider HA, Osman G, Rodriguez-Ruiz A, Maciel CB, Gilmore EJ, Fernandez A, Rosenthal ES, Claassen J, Husain AM, Yoo JY, So EL, Kaplan PW, Nuwer MR, van Putten M, Sutter R, Drislane FW, Trinka E, Gaspard N. American Clinical Neurophysiology Society's Standardized Criti PMID 33475321
Identifiers
NCT: NCT06401707 · 23-39712