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

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ClinicalTrials.gov Identifier: NCT02912364
Recruitment Status : Completed
First Posted : September 23, 2016
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Kimford Jay Meador, Stanford University

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Eslicarbazepine Drug: Carbamazepine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Two Period Crossover Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Actual Study Start Date : July 2016
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eslicarbazepine
Randomized to eslicarbazepine 800mg po bid in crossover design.
Drug: 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.
Other Name: Aptiom

Experimental: Carbamazepine
Randomized to carbamazepine 400mg po bid in crossover design.
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.
Other Name: Tegretol




Primary Outcome Measures :
  1. Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs. [ Time Frame: At the end of each 6-week drug treatment period. ]
    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 :
  1. Overall Z-score for Executive Function. [ Time Frame: At the end of each 6-week drug treatment period. ]
    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.

  2. MCG Paragraph Recall Scores. [ Time Frame: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. ]

    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.


  3. Dual Task Percent of Time in Box. [ Time Frame: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. ]

    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.


  4. Profile of Mood States (POMS) Score. [ Time Frame: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912364


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Sunovion
Investigators
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Principal Investigator: Kimford Meador, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Kimford Jay Meador, Stanford University:

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Responsible Party: Kimford Jay Meador, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02912364     History of Changes
Other Study ID Numbers: 34098
First Posted: September 23, 2016    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kimford Jay Meador, Stanford University:
Eslicarbazepine
Carbamazepine
cognition

Additional relevant MeSH terms:
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Carbamazepine
Eslicarbazepine acetate
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Voltage-Gated Sodium Channel Blockers