Perampanel Titration and Cognitive Effects

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kimford Jay Meador
• Collaborator: Eisai Inc.

Criteria

Inclusion Criteria:

1. Healthy adults between the ages of 18 and 55 years

2. Male or female (using approved birth control methods)

3. Informed consent obtained

Exclusion Criteria:

1. Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease.

2. Presence or history of drug or alcohol abuse or positive urine drug test at screening.

3. 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).

4. Prior adverse reaction to or prior hypersensitivity to perampanel.

5. Prior participation in studies involving perampanel.

6. Subjects who have received any investigational drug within the previous thirty days.

7. Subjects with IQ < 80 as determined by the Peabody Picture Vocabulary Test after enrollment.

8. Positive pregnancy test. Women of childbearing potential will be required to use approved birth control methods during the study.

9. 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.

10. 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.