Back to resultsComparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eslicarbazepine
Carbamazepine
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Eslicarbazepine, Carbamazepine, cognition
Eligibility Criteria
Inclusion Criteria:
- Healthy adults between the ages of 18 and 55 years old.
- Male or female
Exclusion Criteria:
- 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.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Eslicarbazepine
Carbamazepine
Arm Description
Randomized to eslicarbazepine 800mg po bid in crossover design.
Randomized to carbamazepine 400mg po bid in crossover design.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Z-score for Executive Function.
Executive function consists of a composite of measures from the computerized cognitive tests. 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.
MCG Paragraph Recall Scores.
Participants were read a paragraph and were asked to recall content immediately following and twenty minutes after hearing the reading. MCG = Medical College of Georgia.
Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: 0 - 60, higher scores indicate better memory function.
Dual Task Percent of Time in Box.
Participants were asked to use their computer mouse to keep the cursor inside a moving box on the computer screen while simultaneously responding with a button press when a number on the screen exceeded a certain value.
Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period.
Profile of Mood States (POMS) Score.
Participants were asked to rate the extent to which they feel a variety of emotions/feelings. The overall score is presented.
Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: -32 to 200. Lower scores correspond to better mood state.
Full Information
NCT ID
NCT02912364
First Posted
September 14, 2016
Last Updated
May 13, 2019
Sponsor
Stanford University
Collaborators
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02912364
Brief Title
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Official Title
Double-Blind, Randomized, Two Period Crossover Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Eslicarbazepine, Carbamazepine, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eslicarbazepine
Arm Type
Experimental
Arm Description
Randomized to eslicarbazepine 800mg po bid in crossover design.
Arm Title
Carbamazepine
Arm Type
Experimental
Arm Description
Randomized to carbamazepine 400mg po bid in crossover design.
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine
Other Intervention Name(s)
Aptiom
Intervention Description
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
Intervention Name(s)
Carbamazepine
Other Intervention Name(s)
Tegretol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.
Description
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.
Time Frame
At the end of each 6-week drug treatment period.
Secondary Outcome Measure Information:
Title
Overall Z-score for Executive Function.
Description
Executive function consists of a composite of measures from the computerized cognitive tests. 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.
Time Frame
At the end of each 6-week drug treatment period.
Title
MCG Paragraph Recall Scores.
Description
Participants were read a paragraph and were asked to recall content immediately following and twenty minutes after hearing the reading. MCG = Medical College of Georgia.
Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: 0 - 60, higher scores indicate better memory function.
Time Frame
Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.
Title
Dual Task Percent of Time in Box.
Description
Participants were asked to use their computer mouse to keep the cursor inside a moving box on the computer screen while simultaneously responding with a button press when a number on the screen exceeded a certain value.
Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period.
Time Frame
Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.
Title
Profile of Mood States (POMS) Score.
Description
Participants were asked to rate the extent to which they feel a variety of emotions/feelings. The overall score is presented.
Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: -32 to 200. Lower scores correspond to better mood state.
Time Frame
Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults between the ages of 18 and 55 years old.
Male or female
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimford Meador, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
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