Overview

Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults

Status:
Completed
Trial end date:
2018-04-20
Target enrollment:
0
Participant gender:
All
Summary
Double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Stanford University
Collaborator:
Sunovion
Treatments:
Carbamazepine
Eslicarbazepine acetate
Criteria
Inclusion Criteria:

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

2. Male or female

Exclusion Criteria:

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

2. Presence or history of drug or alcohol abuse.

3. The use of concomitant medications, which are known to affect ESL or Carbamazepine or
the use of any concomitant medications that may alter cognitive function (see Section
VII.E for a partial list).

4. Use of oral contraceptive hormones or other medications that could be affected by ESL
or Carbamazepine.

5. Prior adverse reaction to or prior hypersensitivity to either study medication or to
related compounds.

6. Prior participation in studies involving anticonvulsant medications.

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

8. Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.

9. Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at
screening in subjects of Asian descent.