Using perampanel to prevent seizures after cardiac arrest
PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest
This study is testing if the medication perampanel can help prevent seizures in patients who have survived a cardiac arrest and are in a coma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06401707 on ClinicalTrials.gov |
What this trial studies
This pilot randomized placebo-controlled clinical trial aims to evaluate the safety and feasibility of using perampanel for preventing post-cardiac arrest status epilepticus (PCARSE) in patients who have experienced a non-traumatic cardiac arrest. The study will enroll comatose patients who have achieved return of spontaneous circulation within 45 minutes of arrest and will randomize them to receive either perampanel or a placebo after admission to the intensive care unit. The primary outcome will focus on the incidence of severe adverse events, while secondary endpoints will assess seizure incidence, frequency, and time to seizure control.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a non-traumatic out-of-hospital cardiac arrest and are comatose upon ICU admission.
Not a fit: Patients with acute cerebral hemorrhage, severe kidney or liver impairment, or those diagnosed with seizures prior to the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of seizures and improve outcomes for patients recovering from cardiac arrest.
How similar studies have performed: While perampanel has been used in other contexts for seizure management, this specific application in critically ill cardiac arrest patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Edilberto Amorim, MD — University of California, San Francisco
- Study coordinator: Edilberto Amorim, MD
- Email: prosperstudy@ucsf.edu
- Phone: 628-206-3203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.