Perampanel Titration and Cognitive Effects
Recruiting at2 trial locations
KM
Overseen byKimford Meador, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Kimford Jay Meador
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The objective of this study is to determine whether there are any differences in the cognitive abilities and/or behavioral response of normal healthy volunteers across different titration rates of perampanel.
Research Team
KM
Kimford Meador, MD
Principal Investigator
Stanford University
Eligibility Criteria
Inclusion Criteria
Healthy adults between the ages of 18 and 55 years
Male or female (using approved birth control methods)
Informed consent obtained
Exclusion Criteria
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.
See 7 more
Treatment Details
Interventions
- Perampanel (AMPA Receptor Antagonist)
- Placebo (Other)
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kimford Jay Meador
Lead Sponsor
Trials
2
Recruited
80+
Eisai Inc.
Industry Sponsor
Trials
524
Recruited
161,000+
Founded
Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.
Headquarters
Woodcliff Lake, NJ, USA
Known For
Neurology and Oncology
Top Products
Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)
Lynn Kramer
Eisai Inc.
Chief Medical Officer since 2019
MD
Tatsuyuki Yasuno
Eisai Inc.
Chief Executive Officer since 2023
MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University