Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel
Status: Terminated
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Healthy adults between the ages of 18 and 55 years
• Male or female (using approved birth control methods)
• Informed consent obtained
Locations
United States
California
Stanford University
Palo Alto
Illinois
Northwestern University
Chicago
New York
New York University
New York
Time Frame
Start Date: 2021-10-20
Completion Date: 2023-05-01
Participants
Target number of participants: 29
Treatments
Placebo_comparator: Placebo
Participants will take 2mg placebo PO QD for six weeks.
Experimental: PER 1 Week Titration
Participants will take 2mg perampanel PO QD for one week, followed by 4mg perampanel PO QD for five weeks.
Experimental: PER 2 Week Titration
Participants will take 2mg perampanel PO QD for two weeks, followed by 4mg perampanel PO QD for four weeks.
Experimental: PER 4 mg
Participants will take 4mg perampanel PO QD for six weeks
Related Therapeutic Areas
Sponsors
Collaborators: Eisai Inc.
Leads: Kimford Jay Meador