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

NCT02912364 | Completed Phase 4 Results

• 1 other identifier: 34098
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy

Keywords

Eslicarbazepine; Carbamazepine; cognition

Outcome Measures

Primary Outcomes (1)

• Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.

  Z score of cognitive tests at end of each 6-week drug treatment period for each intervention (i.e., Eslicarbazepine and Carbamazepine). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poor cognitive performance compared to the mean and positive numbers represent higher cognitive performance compared to the mean.

  At the end of each 6-week drug treatment period.

Secondary Outcomes (4)

• Overall Z-score for Executive Function.

  At the end of each 6-week drug treatment period.

• MCG Paragraph Recall Scores.

  Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.

• Dual Task Percent of Time in Box.

  Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.

• Profile of Mood States (POMS) Score.

  Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.

Study Arms (2)

Eslicarbazepine

EXPERIMENTAL

Randomized to eslicarbazepine 800mg po bid in crossover design.

Drug: Eslicarbazepine

Carbamazepine

EXPERIMENTAL

Randomized to carbamazepine 400mg po bid in crossover design.

Drug: Carbamazepine

Interventions

Eslicarbazepine 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.

Also known as: Aptiom

Eslicarbazepine

Carbamazepine 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.

Also known as: Tegretol

Carbamazepine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between the ages of 18 and 55 years old.
• Male or female

You may not qualify if:

• Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
• Presence or history of drug or alcohol abuse.
• 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).
• Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
• Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
• Prior participation in studies involving anticonvulsant medications.
• Subjects who have received any investigational drug within the previous thirty days.
• Subjects with IQ \< 70 as determined by the Peabody Picture Vocabulary Test.
• Presence of HLA B\*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.

Sponsors & Collaborators

• Stanford University: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine; eslicarbazepine acetate; Carbamazepine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kimford Meador
• Organization: Stanford University

kmeador@stanford.edu

650-725-6648

Study Officials

• Kimford Meador, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 23, 2016
• Study Start: July 1, 2016
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: June 4, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)