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PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

ConditionsHeart ArrestSeizuresStatus Epilepticus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Acute cerebral hemorrhage or infarction

Pregnancy

Prisoner

Severe kidney function impairment with creatinine clearance inferior to 30 ml/min

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perampanel

    Drug

    Perampanel is a non-competitive AMPA glutamate receptor antagonist.

  • Placebo

    Drug

    Placebo

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: PerampanelActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of perampanel

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

Time frame
7 days
2

Adverse and Serious Adverse Events

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

Time frame
7 days

Secondary outcomes

1

Incidence of post-cardiac arrest refractory status epilepticus

percentage of participants with post-cardiac arrest refractory status epilepticus in perampanel or placebo arms.

Time frame
7 days
2

Incidence of post-cardiac arrest seizures

percentage of participants with post-cardiac arrest seizures in perampanel or placebo arms.

Time frame
7 days
3

Treatment intensity of post-cardiac arrest refractory status epilepticus

number of anti-seizure medications and anesthetics needed for post-cardiac arrest status epilepticus control in perampanel or placebo arms.

Time frame
7 days
4

Time to start of post-cardiac arrest refractory status epilepticus

percentage of participants with post-cardiac arrest refractory status epilepticus in perampanel or placebo arms.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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