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

Stanford University

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: Eslicarbazepine; Drug: Carbamazepine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02912364

34098

Details and patient eligibility

About

Double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.

Full description

This study is a double-blind, randomized, two period crossover design. The study consists of 6 visits over a 21 week period. Forty six (46) normal healthy subjects will be treated with both Eslicarbazepine acetate (ESL, 800 mg/day) and Carbamazepine (CBZ, 800mg/day) for 6 weeks and 3 days each (maintenance 4 weeks and taper 3 days). Each antiepileptic drug (AED) treatment period will be followed by a four day taper and washout period off AED for the remainder of the month. Cognitive and behavioral testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization AED maintenance period, and after the final washout period.

Enrollment: 46 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Eslicarbazepine

Experimental group

Description:

Randomized to eslicarbazepine 800mg po bid in crossover design.

Treatment:

Drug: Eslicarbazepine

Carbamazepine

Experimental group

Description:

Randomized to carbamazepine 400mg po bid in crossover design.

Treatment:

Drug: Carbamazepine