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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06401707
Other study ID # 23-39712
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 20, 2024
Est. completion date October 20, 2026

Study information

Verified date June 2024
Source University of California, San Francisco
Contact Edilberto Amorim, MD
Phone 628-206-3203
Email prosperstudy@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date October 20, 2026
Est. primary completion date May 20, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Perampanel
Perampanel is a non-competitive AMPA glutamate receptor antagonist.
Placebo
Placebo

Locations

Country Name City State
United States Zuckerberg San Francisco General Hospital San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 Critical Care EEG Terminology: 2021 Version. J Clin Neurophysiol. 2021 Jan 1;38(1):1-29. doi: 10.1097/WNP.0000000000000806. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of perampanel percentage of participants who are able to complete the 5-day course of perampanel or placebo. 7 days
Primary Adverse and Serious Adverse Events percentage of participants with treatment-related adverse and serious adverse events in perampanel or placebo arms. 7 days
Secondary Incidence of post-cardiac arrest refractory status epilepticus percentage of participants with post-cardiac arrest refractory status epilepticus in perampanel or placebo arms. 7 days
Secondary Incidence of post-cardiac arrest seizures percentage of participants with post-cardiac arrest seizures in perampanel or placebo arms. 7 days
Secondary Treatment intensity of post-cardiac arrest refractory status epilepticus number of anti-seizure medications and anesthetics needed for post-cardiac arrest status epilepticus control in perampanel or placebo arms. 7 days
Secondary Time to start of post-cardiac arrest refractory status epilepticus percentage of participants with post-cardiac arrest refractory status epilepticus in perampanel or placebo arms. 7 days
Secondary Neurological function at 180 days Distribution of modified Rankin Scale (mRS) score at 180 days in perampanel or placebo arms (mRS range 0 to 6, with higher scores indicating worse outcome) 180 days
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