Trial Search Results

Perampanel Titration and Cognitive Effects

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Kimford Jay Meador

Collaborator: Eisai Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Perampanel 1 week titration
  • Drug: Perampanel 2 week titration
  • Drug: Perampanel 4mg
  • Drug: Placebo

Phase:

Phase 4

Eligibility


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.

Ages Eligible for Study

18 Years - 55 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jordan Seliger
650-460-9260
Not Recruiting