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.