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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.

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My liver function tests are more than five times the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

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)

0 / 5Eligibility criteria met