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

NCT ID: NCT02912364

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-04-20

Brief Summary

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

Detailed 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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Eslicarbazepine

Randomized to eslicarbazepine 800mg po bid in crossover design.

Group Type: EXPERIMENTAL

Eslicarbazepine

Intervention Type: DRUG

Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg daily) . After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.

Carbamazepine

Randomized to carbamazepine 400mg po bid in crossover design.

Group Type: EXPERIMENTAL

Carbamazepine

Intervention Type: DRUG

Healthy adults will be titrated onto Carbamazepine (400 mg bid). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.

Interventions

Eslicarbazepine

Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg daily) . After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.

Intervention Type: DRUG

Carbamazepine

Healthy adults will be titrated onto Carbamazepine (400 mg bid). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.

Intervention Type: DRUG

Other Intervention Names

Aptiom; Tegretol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kimford Jay Meador

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimford Meador, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

34098

Identifier Type: -

Identifier Source: org_study_id