Recruiting

Phase 2

PerampanelPeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Sponsor:

UCLA

Code:

NCT06401707

Conditions

Heart Arrest

Seizures

Status Epilepticus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perampanel

Placebo

Study Details

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.

Conditions

Heart Arrest

Seizures

Status Epilepticus

Study ID

NCT06401707

Start date

May 20, 2024

Status verified date

Jul, 2026

Completion date

Oct 20, 2027

Anticipated

Primary completion date

May 20, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Perampanel

Perampanel oral load of 24mg upon randomization followed by 8mg oral dose daily for four more days (second dose one day after load and total treatment duration is 5 days)

placebo comparator: Placebo

Placebo oral load upon randomization followed by daily placebo oral dose administration for four more days (second dose one day after load and total placebo administration duration is 5 days)

Interventions

Perampanel

Perampanel is a non-competitive AMPA glutamate receptor antagonist.

Placebo

Primary outcome measure

Safety and tolerability of perampanel [ Time Frame: 7 days ]
Adverse and Serious Adverse Events [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Edilberto Amorim, MD

628-206-3203 prosperstudy@ucsf.edu

Kevin Bao, BA

prosperstudy@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

heart arrest
seizure
status epilepticus
prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-29.