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AMPA Receptor Antagonist

Perampanel 4mg for Epilepsy

Phase 4
Recruiting
Led By Kimford Meador, MD
Research Sponsored by Kimford Jay Meador
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 at the end of each week of treatment for 6 weeks.
Awards & highlights

Study Summary

This trial is measuring the effects of different dosages of perampanel on healthy volunteers' cognition and behavior.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of each week of treatment for 6 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of each week of treatment for 6 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
Therapeutic procedure
Composite Z-score of subjective measures as a measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Overall neuropsychological composite Z-score as a measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Secondary outcome measures
Dropouts across the six-week treatment period measure of direct comparison of the 4 titration conditions across 6 weeks of treatment.
Overall behavioral composite Z-score at the end of the maintenance period (study week 6) compared to baseline (study week 1) as a measure of direct comparison of change across the 4 titration conditions.
Overall cognitive composite Z-score at the end of the maintenance period (study week 6) compared to baseline (study week 1) as a measure of direct comparison of change across the 4 titration conditions.
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PER 4 mgExperimental Treatment1 Intervention
Participants will take 4mg perampanel PO QD for six weeks
Group II: PER 2 Week TitrationExperimental Treatment1 Intervention
Participants will take 2mg perampanel PO QD for two weeks, followed by 4mg perampanel PO QD for four weeks.
Group III: PER 1 Week TitrationExperimental Treatment1 Intervention
Participants will take 2mg perampanel PO QD for one week, followed by 4mg perampanel PO QD for five weeks.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will take 2mg placebo PO QD for six weeks.

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Who is running the clinical trial?

Kimford Jay MeadorLead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Epilepsy
55 Patients Enrolled for Epilepsy
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,982 Total Patients Enrolled
29 Trials studying Epilepsy
6,491 Patients Enrolled for Epilepsy
Kimford Meador, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
101 Total Patients Enrolled
2 Trials studying Epilepsy
101 Patients Enrolled for Epilepsy

Media Library

Perampanel (AMPA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04417907 — Phase 4
Epilepsy Research Study Groups: Placebo, PER 1 Week Titration, PER 2 Week Titration, PER 4 mg
Epilepsy Clinical Trial 2023: Perampanel Highlights & Side Effects. Trial Name: NCT04417907 — Phase 4
Perampanel (AMPA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417907 — Phase 4

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~30 spots leftby Apr 2025