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Perampanel 4mg for Epilepsy
Study Summary
This trial is measuring the effects of different dosages of perampanel on healthy volunteers' cognition and behavior.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a serious health condition related to your heart, hormones, blood, liver, brain, mental health, or kidneys.You have previously taken part in studies involving perampanel.You have tried to take your own life before, or have had thoughts of wanting to do so in the past 6 months.You had a bad reaction or allergy to perampanel before.
- Group 1: Placebo
- Group 2: PER 1 Week Titration
- Group 3: PER 2 Week Titration
- Group 4: PER 4 mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
What can be expected from the one-week titration process of Perampanel?
"Our team at Power judged the safety of perampanel one week titration to be a 3 due to this being classified as Phase 4, which is indicative of said treatment's approval."
What is the ultimate goal of this experiment?
"Per the trial sponsor, Eisai Inc., the primary outcome for this study is Overall Neuropsychological Composite Z-score as a measure of direct comparison across the titration conditions over 6 weeks. There are secondary outcomes being studied including overall cognitive and behavioral composite Z-scores at week 6 compared to baseline. These scores indicate how far away from average performance an individual patient is; 0 indicates average performance while negative numbers mean poorer performance than average and positive numbers signify better than typical results."
Is this a pioneering exploration of its kind?
"Research into Perampanel 1 week titration began in 2017, with the initial trial sponsored by Eisai Inc. and involving 60 participants. This was followed by N/A drug approval and 11 currently active studies across 51 cities and 9 countries."
How many participants are actively engaged in this trial?
"Affirmative. According to records on clinicaltrials.gov, this medical study is currently enrolling patients; it was initially made available on October 20th 2021 and recently updated on the 25th of October 2022. 103 individuals from 3 different sites need to be recruited for participation in the trial."
Are there still openings available for the clinical trial?
"Affirmative. Information available on clinicaltrials.gov shows that this medical trial, which was initially published on October 20th 2021, is currently searching for participants. 103 individuals need to be enrolled from three separate sites."
Are there any criteria for me to qualify as a participant in this research?
"This medical experiment will be conducting research on 103 participants with aura, between the ages of 18 and 55 years old. In order to qualify for this study, potential patients should satisfy two conditions: Be a male or female adult who is in good health and utilizing an accepted form of birth control."
Does this experiment admit geriatric participants?
"To qualify for this trial, the age of participants must be within the range of 18 to 55 years old."
What previous experiments have been conducted to determine the efficacy of a Perampanel 1 week titration regimen?
"Presently, 11 studies exploring Perampanel 1 week titration are in progress with none currently residing in Stage 3 of the research process. Most of these trials emanate from New york City but there are a total of 93 sites conducting this type of investigation."
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