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Anti-epileptic drug

Healthy males for Healthy Subjects

Phase 4
Waitlist Available
Led By David Chuang, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and post-dose of drug intake, 7 hours
Awards & highlights

Study Summary

This trial will examine whether the epilepsy drug perampanel has any effect on commonly used neurophysiology tests. Twelve healthy male subjects will receive 6mg of perampanel, have their blood drawn, and then have their neurophysiology tested. There is no placebo group or randomization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and post-dose of drug intake, 7 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and post-dose of drug intake, 7 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Baseline Brainstem Auditory Evoked Potential (Waves I, III, V) Amplitude
Change in Baseline Brainstem Auditory Evoked Potential (Waves I, III, V) Latency
Change in Baseline Electroencephalography Background Frequency Content
+4 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT03653741
33%
vertigo
25%
dizziness
25%
drowsiness
25%
headache
17%
nausea
8%
fatigue
8%
nystagmus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Males

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy malesExperimental Treatment1 Intervention
healthy males will undergo EEG, VEP, BAER, and SEP testing, then take a single dose of Perampanel 6 MG pill (intervention), then have blood drawn and undergo the 4 tests mentioned previously for a second time
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel 6 MG
2018
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,860 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
154,087 Total Patients Enrolled
David Chuang, M.D.Principal InvestigatorNYP/WCMC

Frequently Asked Questions

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

Does the study accept participants aged 70 or above?

"This clinical trial is accepting participants aged 18 and up to 50 years old."

Answered by AI

Does the intake of Healthy males present any risks to individuals?

"There is extensive clinical data confirming the safety of healthy males, thus earning this treatment a score of 3."

Answered by AI

What research has been undertaken regarding the health of male volunteers?

"Currently, 11 clinical trials are researching Healthy males with 0 of those in the Phase 3 stage. The majority of these experiments take place within New york City but there are 93 other sites around America conducting research on this category."

Answered by AI

Is this medical trial accepting new participants at present?

"Unfortunately, this trial is not currently accepting participants. The study was originally published on October 1st 2018 and last modified December 20th 2021. Fortunately, 841 trials with healthy subjects (HS) are admitting patients at the moment as well as 11 studies that only require male volunteers."

Answered by AI

May I be included in this medical experiment?

"The inclusion criteria for this medical trial stipulates that participants must be between 18 to 50 years of age and possess healthy subject status. The research team is seeking a total of 12 potential patients."

Answered by AI

Does this trial present a paradigm shift in the field?

"As of now, 11 active trials for Healthy males are transpiring internationally in 9 countries and 51 cities. In 2017, Eisai Inc. sponsored the inaugural trial related to this topic which required 60 participants and culminated with an unspecified step in drug approval process. Subsequently, 52 studies have since been successfully concluded."

Answered by AI

How many participants are being included in the research?

"At this moment in time, recruitment for the study has been concluded. It began on October 1st 2018 and ended December 20th 2021. However, there are 841 studies actively seeking healthy subjects (hs) as well as 11 trials recruiting Healthy males right now."

Answered by AI

Who else is applying?

What state do they live in?
New York
New Jersey
How old are they?
18 - 65
What site did they apply to?
Neurophysiology Laboratory
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby Mar 2025