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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights
Study Summary
This trial aims to understand epilepsy treatment better and see if a new drug is safe and effective. 25 patients will be tested and monitored for 96 weeks.
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.Check my eligibility
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.See study design
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 belowSelect...
I have severe epilepsy that didn't stop after two types of medication.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Secondary outcome measures
2. Total duration of intravenous anesthetic infusion.
3. The number of antiseizure medications used.
+7 moreSide effects data
From 2021 Phase 4 trial • 54 Patients • NCT0328812928%
Dizziness
17%
Fatigue
15%
Somnolence
11%
Vomiting
9%
Nasopharyngitis
9%
Irritability
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%
Mental status changes
2%
Sudden unexplained death in epilepsy
2%
Transient ischaemic attack
2%
Suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Perampanel 12 mg
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
Find a Location
Who is running the clinical trial?
Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,448 Total Patients Enrolled
Maysaa Basha, MDPrincipal InvestigatorWayne State University
Wazim Mohamed, MDPrincipal InvestigatorWayne State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have had seizures caused by very low or high blood sugar.I have a history of mental health issues or thoughts of harming myself.I am 18 years old or older.I have severe kidney problems or am on dialysis.You have a severe allergy to any anti-epileptic drug (AED).I have severe epilepsy that didn't stop after two types of medication.I have used or am currently using PMP.I use oral contraception and am open to discussing other methods.I am not pregnant or have a negative pregnancy test if capable of becoming pregnant.I am not taking medications like Rifampin or St John's Wort.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm prospective study
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for the trial limited to individuals under 35 or can those of greater age participate?
"This clinical trial welcomes all participants over the age of majority, up to a cap of 100 years old."
Answered by AI
How can patients be guaranteed a level of security when partaking in single-arm prospective studies?
"Single arm prospective study is an approved treatment, so our team rated its safety a 3."
Answered by AI
Is enrollment still ongoing for this study?
"The clinical trial, first posted on February 1st 2023 and last modified on June 1st of the same year, is no longer open to new participants. However, 11 other investigations are currently recruiting patients."
Answered by AI
Am I eligible to become a participant in this investigation?
"This clinical trial is seeking 25 individuals aged 18 to 100 with refractory status epilepticus. To qualify, subjects must satisfy certain conditions such as being over the age of majority and requiring IV anaesthetic infusions for RSE which has been unresponsive to benzodiazepines and anti-epileptic drugs (AEDs). Additionally, female participants taking oral birth control pills should be made aware of other contraceptive options if they plan on participating in this study long term."
Answered by AI
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