What side effects are associated with this type of intervention?

Common treatments for Status Epilepticus include benzodiazepines (e.g., lorazepam, diazepam), antiepileptic drugs (e.g., phenytoin, valproate), and newer agents like Perampanel. Benzodiazepines can cause sedation, respiratory depression, and hypotension. Phenytoin may lead to cardiac arrhythmias, gingival hyperplasia, and ataxia. Valproate is associated with hepatotoxicity, weight gain, and thrombocytopenia. Perampanel, an AMPA receptor antagonist, can cause dizziness, somnolence, irritability, and in some cases, serious psychiatric and behavioral reactions such as aggression and hostility.

What prior FDA approvals exist?

The FDA has approved several treatments for Status Epilepticus, including benzodiazepines like lorazepam and diazepam, which are commonly used as first-line treatments. For refractory cases, other antiepileptic drugs such as fosphenytoin, valproate, and levetiracetam have been utilized. Perampanel, an AMPA receptor antagonist, is being studied for its efficacy in refractory Status Epilepticus, but it is not yet FDA-approved for this specific indication. The focus on AMPA receptor antagonists like Perampanel represents a novel approach in targeting excitatory neurotransmission in epilepsy management.

What other types of research exist?

Promising alternatives to Perampanel for Status Epilepticus patients include intravenous valproic acid, which has shown efficacy in acute migraine and epilepsy management, and fenfluramine, which has demonstrated effectiveness in treatment-resistant seizures in Dravet syndrome. Additionally, the ketogenic diet has been beneficial for intractable epilepsy, including SE. These options should be discussed with a healthcare provider to determine the best individualized treatment plan.

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AMPA Receptor Antagonist

Perampanel for Status Epilepticus

Phase 4

Waitlist Available

Led By Maysaa Basha, MD

Research Sponsored by Wayne State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients in RSE that require IV anesthetic infusions. Note: RSE is defined as status epilepticus that fails to terminate after an adequate dose of benzodiazepines (1st line agents) and an AED (2nd line agent). Adequate doses have been defined in the screening (below).

Be older than 18 years old

Must not have

Anoxic brain injury as etiology of status epilepticus

Mild, moderate or severe hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 6 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial is testing Perampanel, a drug that blocks overactive brain signals, to help patients with severe seizures that don't respond to other treatments. The study aims to see if this drug can effectively and safely control these difficult-to-treat seizures.

Who is the study for?

Adults over 18 with refractory status epilepticus (RSE), which is a type of seizure that doesn't stop after treatment with first and second-line medications. Participants must not be pregnant, have severe liver or kidney issues, anoxic brain injury as the cause of RSE, or take certain other drugs that affect how Perampanel works.

What is being tested?

The trial tests Perampanel's effectiveness and safety in treating RSE at WSU for about 96 weeks. It includes initial screening, medical history review, physical and neurological exams, followed by two clinic visits. Patient data will be collected to identify outcome determinants.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with AEDs like Perampanel may include dizziness, sleepiness, irritability, aggression or anger outbursts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe epilepsy that didn't stop after two types of medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My seizures are due to a lack of oxygen to the brain.

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I have liver problems.

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I have had seizures caused by very low or high blood sugar.

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I have a history of mental health issues or thoughts of harming myself.

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I have severe kidney problems or am on dialysis.

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I have used or am currently using PMP.

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I am not pregnant or have a negative pregnancy test if capable of becoming pregnant.

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I am not taking medications like Rifampin or St John's Wort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Secondary study objectives

2. Total duration of intravenous anesthetic infusion.

3. The number of antiseizure medications used.

+7 more

Side effects data

From 2021 Phase 4 trial • 54 Patients • NCT03288129

28%

Dizziness

17%

Fatigue

15%

Somnolence

11%

Vomiting

Nasopharyngitis

Headache

Irritability

Nausea

Ear infection

Upper respiratory tract infection

Balance disorder

Memory impairment

Aggression

Depression

Oropharyngeal pain

Sudden unexplained death in epilepsy

Transient ischaemic attack

Mental status changes

Suicidal ideation

100%

80%

60%

40%

20%

Study treatment Arm

Perampanel 12 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm prospective studyExperimental Treatment1 Intervention

* Adults patients equal or greater than 18 years * Patients in RSE that require IV anesthetic infusions. Note: RSE is defined as status epilepticus that fails to terminate after an adequate dose of benzodiazepines (1st line agents) and an AED (2nd line agent). Adequate doses have been defined in the screening (below). * Patients taking oral contraception who will be on the study long term should be informed about additional alternative methods of contraception.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perampanel

2014

Completed Phase 4

~2890

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Status Epilepticus (SE) is a neurological emergency characterized by prolonged or repeated seizures without recovery between them. The most common treatments for SE include benzodiazepines, which enhance the effect of the neurotransmitter GABA at the GABA-A receptor, leading to increased inhibitory effects in the brain. Another class includes antiepileptic drugs like Perampanel, an AMPA receptor antagonist, which inhibits excitatory neurotransmission by blocking AMPA receptors, thereby reducing neuronal excitability. This is crucial for SE patients as it helps to quickly terminate ongoing seizures and prevent neuronal damage. Other treatments like phenytoin and valproate work by stabilizing neuronal membranes and reducing repetitive neuronal firing. These mechanisms are vital for controlling SE, minimizing brain injury, and improving patient outcomes.