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Anti-epileptic

Perampanel for Post-Cardiac Arrest Seizures (PROSPER Trial)

Phase 2
Recruiting
Led By Edilberto Amorim, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Comatose on admission - defined as not following commands
Non-traumatic, out-of-hospital cardiac arrest
Must not have
Acute cerebral hemorrhage or infarction
Severe kidney function impairment with creatinine clearance inferior to 30 ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days

Summary

This trial aims to test a new drug called perampanel to see if it can prevent brain injury in patients who have survived cardiac arrest. The drug will be compared to a placebo in a small study

Who is the study for?
This trial is for patients who have survived a cardiac arrest but are at risk of developing seizures due to brain injury. It's not specified who can't join, so it's important to consult with the study team for exclusion criteria.
What is being tested?
The trial is testing whether Perampanel can prevent seizures after cardiac arrest. It's a pilot study, meaning it’s in early stages, and participants will be randomly assigned to either receive Perampanel or a placebo without active medication.
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with Perampanel may include dizziness, sleepiness, fatigue, irritability and falls. Consultation with healthcare providers for detailed risks is advised.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was not able to follow commands upon hospital admission.
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I experienced a sudden cardiac arrest outside of a hospital without any injury causing it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a recent stroke or brain bleed.
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My kidney function is severely impaired.
Select...
My liver function tests are more than five times the normal limit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse and Serious Adverse Events
Safety and tolerability of perampanel
Secondary study objectives
Incidence of post-cardiac arrest refractory status epilepticus
Incidence of post-cardiac arrest seizures
Neurological function at 180 days
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PerampanelActive Control1 Intervention
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)
Group II: PlaceboPlacebo Group2 Interventions
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)

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,580 Previous Clinical Trials
15,177,448 Total Patients Enrolled
Edilberto Amorim, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
30 Total Patients Enrolled
~35 spots leftby May 2026
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