52 Participants Needed

Perampanel for Post-Cardiac Arrest Seizures

(PROSPER Trial)

KB
EA
Overseen ByEdilberto Amorim, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Francisco
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Perampanel (Fycompa) for post-cardiac arrest seizures?

Perampanel (Fycompa) is effective in controlling seizures in people with epilepsy, particularly focal-onset seizures and generalized tonic-clonic seizures, as shown in various studies. While these studies focus on epilepsy, the drug's ability to manage seizures in these conditions suggests it might also help with post-cardiac arrest seizures.12345

Is Perampanel safe for humans?

Perampanel, also known as Fycompa, has been studied for its safety in treating epilepsy. It is generally well tolerated, with common side effects including dizziness, sleepiness, fatigue, and irritability, which are usually mild to moderate in intensity.13567

How is the drug Perampanel unique for treating post-cardiac arrest seizures?

Perampanel is unique because it works by blocking glutamate receptors in the brain, which is different from many other seizure medications that target different pathways. This mechanism may offer a novel approach for managing seizures after cardiac arrest, where standard treatments are not well-established.12468

Research Team

EA

Edilberto Amorim, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

I was revived from a cardiac arrest in under 45 minutes.
I experienced a sudden cardiac arrest outside of a hospital without any injury causing it.
I was not able to follow commands upon hospital admission.
See 1 more

Exclusion Criteria

I have had a recent stroke or brain bleed.
My liver function tests are more than five times the normal limit.
Pregnancy
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either perampanel or placebo for post-cardiac arrest status epilepticus prevention

5 days
Daily administration in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

Long-term follow-up

Neurological function assessed at 180 days post-treatment

180 days

Treatment Details

Interventions

  • Perampanel
Trial Overview 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.
Participant Groups
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)

Perampanel is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as Fycompa for:
  • Partial-onset epilepsy (with or without secondary generalized seizures)
  • Primary generalized tonic-clonic seizures
🇺🇸
Approved in United States as Fycompa for:
  • Partial-onset seizures (with or without secondary generalized seizures)
  • Primary generalized tonic-clonic seizures
  • Monotherapy and adjunctive therapy for focal epilepsy (with or without secondary generalized seizures) in patients aged 4 years and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Findings from Research

Perampanel has been shown to be effective in reducing seizure frequency in patients with epilepsy, demonstrating significant clinical efficacy in multiple studies.
The safety profile of perampanel indicates that while it is generally well-tolerated, it can cause side effects such as dizziness and fatigue, which should be monitored in patients.
Perampanel (Fycompa): A Review of Clinical Efficacy and Safety in Epilepsy.Greenwood, J., Valdes, J.[2020]
In a study of 77 patients with focal-onset seizures, perampanel (PER) as an early add-on therapy resulted in a 60% reduction in seizure frequency for over half of the participants after 12 months, with a retention rate of 79.2%.
PER was particularly effective for patients experiencing focal to bilateral tonic-clonic seizures, achieving a 60% seizure-free rate, although 40.3% of patients reported mild adverse events, leading to a 15.6% discontinuation rate due to side effects.
Perampanel effectiveness and safety as early add-on treatment for focal-onset seizures: PEREAGAL study.Rodríguez-Osorio, X., Lema-Facal, T., Rubio-Nazábal, E., et al.[2022]
Perampanel is an effective adjunctive treatment for patients aged 12 and older with primary generalized tonic-clonic seizures and partial-onset seizures, showing significant improvements in seizure control during phase III trials lasting 17 to 19 weeks, and sustained control for up to 4 years in some cases.
The drug is generally well tolerated, with most side effects being mild to moderate and related to the central nervous system, such as dizziness and fatigue, making it a viable option for patients with drug-resistant seizures.
Perampanel: A Review in Drug-Resistant Epilepsy.Frampton, JE.[2021]

References

Perampanel (Fycompa): A Review of Clinical Efficacy and Safety in Epilepsy. [2020]
Perampanel effectiveness and safety as early add-on treatment for focal-onset seizures: PEREAGAL study. [2022]
Perampanel: A Review in Drug-Resistant Epilepsy. [2021]
Effectiveness and safety of perampanel as early add-on treatment in patients with epilepsy and focal seizures in the routine clinical practice: Spain prospective study (PERADON). [2021]
Perampanel as First Adjunctive Treatment in Patients with Focal-Onset Seizures in the FAME Study: Post hoc Analyses of Dose-Related Efficacy, Safety and Clinical Factors Associated with Response. [2022]
Perampanel: a new add-on treatment for epilepsy. [2021]
A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. [2022]
Perampanel-Induced Cataplexy in a Young Male with Generalized Epilepsy. [2023]
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