Perampanel for Status Epilepticus

Recruiting in Palo Alto (17 mi)

Overseen byWazim Mohamed, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Wayne State University

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

I use oral contraception and am open to discussing other methods.

Exclusion Criteria

I am cautious with medications that affect liver enzymes, like some seizure drugs.

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

I have liver problems.

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Participant Groups

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.

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.

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