PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

NCT06401707 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-39712
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

heart arrest; seizure; status epilepticus; prophylaxis

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of perampanel

  percentage of participants who are able to complete the 5-day course of perampanel or placebo.

  7 days

• Adverse and Serious Adverse Events

  percentage of participants with treatment-related adverse and serious adverse events in perampanel or placebo arms.

  7 days

Secondary Outcomes (5)

• Incidence of post-cardiac arrest refractory status epilepticus

  7 days

• Incidence of post-cardiac arrest seizures

  7 days

• Treatment intensity of post-cardiac arrest refractory status epilepticus

  7 days

• Time to start of post-cardiac arrest refractory status epilepticus

  7 days

• Neurological function at 180 days

  180 days

Study Arms (2)

Perampanel

ACTIVE COMPARATOR

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)

Drug: Perampanel

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

Perampanel DRUG

Perampanel is a non-competitive AMPA glutamate receptor antagonist.

Also known as: Fycompa

Perampanel

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 30159874 BACKGROUND

• 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.

  PMID: 33475321 BACKGROUND

Related Links

• Trial Website

MeSH Terms

Conditions

Heart Arrest; Seizures; Status Epilepticus

Interventions

perampanel

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edilberto Amorim, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edilberto Amorim, MD

CONTACT

628-206-3203; prosperstudy@ucsf.edu

Kevin Bao, BA

CONTACT

prosperstudy@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)