Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401707
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-02
Brief Title:
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSPER
Brief 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
Detailed Description:
More than 500000 Americans have a cardiac arrest every year and 100000 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 ie 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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None