Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus

NCT05684978 | Terminated Phase 4 FDA Drug

• 1 other identifier: IRB-22-05-4691
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This project is aiming to better understand the use of perampanel as an appropriate standard-of-care therapy for treatment refractory status epilepticus (RSE), to identify determinants of outcomes, and establish safety. The study will recruit 25 patients at WSU. The study will last for about 96 weeks and will involve a screening visit and two in clinic visits at 3 and 6 months. If the subjects give written informed consent and meet all eligibility criteria they will be clinically evaluated and will be given the study drug. This study will involve recording of patients medical history, drug history and epilepsy history. A physical exam and a and neurological exam will also be performed to study the heath status of the participant. Results and patient information will be stored in a database for analysis to find commonality among key factors that have been seen in past research.

Conditions

Refractory Status Epilepticus

Keywords

Status Epilepticus; Epilepticus; Epilepsy; Perampanel; Clinical trial for epilepsy; Epilepsy treatment; Seizure; seizure treatment; generalized tonic-clonic seizures; focal seizures; Refractory status epilepticus; (RSE); fycompa

Outcome Measures

Primary Outcomes (1)

• Primary Outcomes

  Successful wean of IV anesthetics without recurrence of status epilepticus. a. Determined by absence of clinical and electrographic seizure activity.

  Within 48 hours of stopping intravenous anesthetics

Secondary Outcomes (10)

• Secondary Outcomes

  3 months and 6 months

• 2. Total duration of intravenous anesthetic infusion.

  90 Days

• 3. The number of antiseizure medications used.

  90 Days

• 3. Total duration of intubation

  90 days

• Total ICU and in-hospital length of stay

  90 days

Study Arms (1)

Single arm prospective study

EXPERIMENTAL

* 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.

Drug: Perampanel

Interventions

Perampanel DRUG

The purpose of this study is to determine the efficacy of Perampanel, an approved antiseizure medication, in the treatment of refractory status epilepticus (RSE), to identify determinants of outcomes, and establish safety.

Also known as: Fycompa

Single arm prospective study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Childbearing potential female who has a positive pregnancy test result or is otherwise known to be pregnant. Hypoglycemia or hyperglycemia induced seizures
• Mild, moderate or severe hepatic impairment
• Severe renal impairment or on hemodialysis
• History of psychiatric illness or suicidal behavior/ideation
• Previous or current use of PMP
• Known severe allergy to any AED
• Anoxic brain injury as etiology of status epilepticus
• Use caution in patients taking moderate and strong CYP3A4 Inducers (including carbamazepine, oxcarbazepine, and phenytoin)
• Patients on other forms of strong CYP3A4 (e.g. Rifampin, St John's Wart, etc).

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Status Epilepticus; Epilepsy; Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Maysaa Basha, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Wazim Mohamed, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 13, 2023
• Study Start: October 10, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)