Seizures Clinical Trial
— PROSPEROfficial title:
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Zuckerberg San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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
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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