Status:
TERMINATED
Perampanel Titration and Cognitive Effects
Lead Sponsor:
Kimford Jay Meador
Collaborating Sponsors:
Eisai Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief 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 per...
Detailed Description
This is a randomized, double-blind, parallel group design across different titration rates of perampanel in healthy volunteers. The study consists of 8 visits, 4 of which will occur at the participant...
Eligibility Criteria
Inclusion
- Healthy adults between the ages of 18 and 55 years
- Male or female (using approved birth control methods)
- Informed consent obtained
Exclusion
- Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease.
- Presence or history of drug or alcohol abuse or positive urine drug test at screening.
- The use of concomitant medications, which are known to affect perampanel or the use of any concomitant medications that may alter cognitive function (see Section VIII.F for a partial list).
- Prior adverse reaction to or prior hypersensitivity to perampanel.
- Prior participation in studies involving perampanel.
- Subjects who have received any investigational drug within the previous thirty days.
- Subjects with IQ \< 80 as determined by the Peabody Picture Vocabulary Test after enrollment.
- Positive pregnancy test. Women of childbearing potential will be required to use approved birth control methods during the study.
- Presence of lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening.
- Invalid results on computerized cognitive tests at screening as indicated by a 'No' on any of the validity indicators generated in the CNS Vital Signs report.
Key Trial Info
Start Date :
October 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04417907
Start Date
October 20 2021
End Date
May 1 2023
Last Update
June 6 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Palo Alto, California, United States, 94304
2
Northwestern University
Chicago, Illinois, United States, 60611
3
New York University
New York, New York, United States, 10016