Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06401707
Study type Interventional
Source University of California, San Francisco
Contact Edilberto Amorim, MD
Phone 628-206-3203
Email prosperstudy@ucsf.edu
Status Recruiting
Phase Phase 2
Start date May 20, 2024
Completion date October 20, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT02850913 - Doxycycline for the Treatment of Nodding Syndrome Phase 2
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Not yet recruiting NCT06045676 - Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
Completed NCT03722212 - Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT02897856 - Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures Phase 4
Completed NCT01236001 - Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older N/A
Completed NCT01239212 - Dosing of Levetiracetam (Keppra) in Neonates Phase 1/Phase 2
Completed NCT01703468 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions Phase 1
Completed NCT01702623 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions Phase 1
Recruiting NCT02216500 - Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy N/A
Completed NCT00236717 - A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Terminated NCT03790436 - Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet N/A
Completed NCT06451289 - Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures
Recruiting NCT02552511 - Epidemiology Study on Neonatal Seizure
Recruiting NCT05339126 - RNS System LGS Feasibility Study Phase 2
Active, not recruiting NCT04595786 - The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection N/A
Recruiting NCT04770337 - Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy N/A