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This trial will study the effects of perampanel on seizure frequency in children with epileptic syndrome and partial-onset seizures. They will measure the 50% responder rate during the maintenance period of the study.
- Pediatric Epilepsy
- Partial Seizures
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You have had a very serious seizure that required a hospital stay in the past 6 months.You have had thoughts of wanting to harm yourself with or without a plan in the past 6 months.You have a surgery planned for epilepsy within 6 months after the screening visit.You have a worsening condition in your brain or spinal cord, such as degenerative diseases or growing tumors.You cannot take benzodiazepines for anything except epilepsy from one month before the start of the study until it is over. However, you can use benzodiazepines for controlling seizures or as emergency medication.If you have had a VNS, RNS, or DBS implanted less than 5 months ago, or if there have been changes to the settings of these devices within the last 4 weeks.You have taken perampanel within the last 30 days or stopped taking it because of side effects or it didn't work for you in the past.You weigh less than 4 kilograms at the first visit.Cohort 1 includes children from 1 month to less than 18 years old. Cohort 2 includes children from 1 month to less than 2 years old. Babies under 1 year old must have been at least 36 weeks along when they were born.You have been diagnosed with epilepsy in childhood or epilepsy with partial-onset seizures, with or without spreading to the whole body.You had 4 or more seizures in the 4 weeks before the study starts.You don't have a condition that's making your epilepsy worse, like a brain problem confirmed by a doctor or brain scan.You are taking a specific number of approved medications for epilepsy, including medical marijuana. The doses of these medications must be stable for a certain period of time before the study.You have had pseudo-seizures (not related to epilepsy) in the past 5 years.
- Group 1: Perampanel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is Perampanel Oral Suspension likely to cause harm to patients?
"While there is some data suggesting Perampanel Oral Suspension is safe, it only received a 2 because there currently no clinical trials supporting its efficacy."
If a patient is under 40, do they still qualify for the research program?
"The age requirements for this particular trial are that potential participants must be between 1 month and 18 years old. Out of the 12 clinical trials, 128 focus on pediatric patients while 197 center around senior citizens."
Are there any precedents for a Perampanel Oral Suspension clinical trial?
"The first clinical trial for Perampanel Oral Suspension occurred in 2017 at Stony Brook University Medical Center. To date, there have been 52 completed studies and 11 ongoing trials. A large number of these are being conducted near Hackensack, New Jersey."
Does this trial set a precedent for other similar trials?
"Research for Perampanel Oral Suspension began in 2017 with a 60 person trial sponsored by Eisai Inc. N/A drug approval was given following the successful completion of the initial study and, as of today, there are 11 live trials taking place in 51 cities across 9 countries."
How many people are involved in this clinical trial?
"Yes, the trial is still recruiting patients. The posting on clinicaltrials.gov shows that the last edit was on 11/16/2022 and that they are looking for 100 participants from 8 different locations."
In how many different places is this trial taking place?
"There are 8 available for this clinical trial including Northeast Regional Epilepsy Group in Hackensack, Pediatric Epilepsy and Neurology Specialists in Tampa, and Seattle Children's Hospital in Seattle."
Are people currently being accepted into this trial?
"The listed clinical trial on clinicaltrials.gov appears to be ongoing, with the most recent update being from November 16th, 2020. This study is looking for 100 individuals at 8 different locations."
If I meet the requirements, may I sign up for this experiment?
"This trial is looking for 100 individuals that experience aura and meet the following age, diagnosis, and medication requirements: between 1 month to 18 years old with a confirmed epilepsy diagnosis who are taking up to 4 approved antiepileptic drugs--one of which can be prescription medical marijuanad epilepsy diagnosis who are taking up to 4 approved antiepileptic drugs--one of which can be prescription medical marijuana in countries where it is not considered an illegal substance. The individual must also be stable on their current AED doses for at least 4 weeks prior to enrollment."
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