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Perampanel for Epilepsy

Phase 4
Waitlist Available
Led By Aashit Shah, MD
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (>18 years-old) who are scheduled to undergo brain surgery and need antiepileptic medication for prophylaxis or treatment of seizures
Able to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Study Summary

This trial will help determine how well the drug perampanel works in treating patients with epilepsy by measuring how much of the drug crosses the blood brain barrier.

Eligible Conditions
  • Epilepsy
  • Seizures

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood brain barrier serum levels

Side effects data

From 2021 Phase 4 trial • 54 Patients • NCT03288129
28%
Dizziness
17%
Fatigue
15%
Somnolence
11%
Vomiting
9%
Irritability
9%
Nasopharyngitis
9%
Headache
7%
Nausea
7%
Ear infection
6%
Upper respiratory tract infection
6%
Balance disorder
6%
Memory impairment
6%
Aggression
6%
Depression
6%
Oropharyngeal pain
2%
Sudden unexplained death in epilepsy
2%
Transient ischaemic attack
2%
Mental status changes
2%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perampanel 12 mg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group oneExperimental Treatment1 Intervention
The Group 1 patients will be taking PER up to 14 days following surgical intervention as per discretion of the treating neurosurgeon.
Group II: Group TwoExperimental Treatment1 Intervention
The Group 2 patients will be taking PER as part of their maintenance AED regimen and will continue on the same maintenance dosage postoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel
FDA approved

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor
70 Previous Clinical Trials
12,690 Total Patients Enrolled
Aashit Shah, MD2.33 ReviewsPrincipal Investigator - Physician
Carilion Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have registered for this experiment thus far?

"Affirmative. The current records on clinicaltrials.gov indicate that this trial, first posted November 1st 2019, is currently recruiting participants. 25 subjects are required from one medical site."

Answered by AI

Are there available slots left for participation in this clinical experiment?

"Per the information found on clinicaltrials.gov, this experiment is actively seeking participants as of today's date. The trial was initially published to the site on November 1st 2019 and has since been updated lastly on September 8th 2021."

Answered by AI

Has the FDA sanctioned Perampanel for therapeutic applications?

"After assessing the safety of Perampanel, our team at Power awarded it a score of 3 due to its Phase 4 status hinting that this drug is approved."

Answered by AI

What prior investigations have been conducted utilizing Perampanel?

"Currently, 11 studies concerning Perampanel are underway with none of them situated in Phase 3. Most research activities for this medication take place in New york City but there are 93 other locations conducting investigations as well."

Answered by AI

Is this a groundbreaking research initiative?

"Presently, there are 11 active trials for Perampanel spanning 51 cities and 9 countries. Starting in 2017 with an Eisai Inc.-sponsored trial involving 60 patients, over the past four years a total of 52 studies have concluded their drug approval stage."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Mar 2025