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Trial record 5 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: Eslicarbazepine
Drug: Carbamazepine
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eslicarbazepine, Then Carbamazepine Carbamazepine, Then Eslicarbazepine
Hide Arm/Group Description Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg once daily). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to receive Carbamazepine, 400mg twice daily. Healthy adults will be titrated onto Carbamazepine (400mg twice daily). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to Eslicarbazepine Acetate, 800mg daily.
Period Title: Treatment 1
Started 23 23
Received Intervention 18 18
Completed 13 11
Not Completed 10 12
Period Title: Washout Period
Started 13 11
Completed 13 11
Not Completed 0 0
Period Title: Treatment 2
Started 13 11
Received Intervention 12 11
Completed 12 11
Not Completed 1 0
Arm/Group Title All Participants
Hide Arm/Group Description Participants who received either Eslicarbazepine Acetate (800mg once daily), or Carbamazepine, 400mg twice daily.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
38.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
18
  39.1%
Male
28
  60.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
African American
3
   6.5%
Asian
13
  28.3%
Hispanic/Latino
6
  13.0%
White/Caucasian
24
  52.2%
Education Level   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
15.0  (1.9)
[1]
Measure Description: Education level is reported as the average number of years spent in school.
IQ Estimate   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 46 participants
98.6  (12.2)
[1]
Measure Description:

IQ scores are generally interpreted as follows

  • Over 140 - Genius or near genius
  • 120 - 140 - Very superior intelligence
  • 110 - 119 - Superior intelligence
  • 90 - 109 - Normal or average intelligence
  • 80 - 89 - Dullness
  • 70 - 79 - Borderline deficiency
  • Under 70 - Definite feeble-mindedness
1.Primary Outcome
Title Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (completed treatment 2 in the participant flow) are included in the analysis.
Arm/Group Title Eslicarbazepine Carbamazepine
Hide Arm/Group Description:
Eslicarbazepine Acetate (800mg once daily).
Carbamazepine (400mg twice daily).
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Z-score
.001  (.50) -.23  (.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eslicarbazepine, Carbamazepine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < .001
Comments [Not Specified]
Method t-test, 2 sided
Comments degrees of freedom = 22
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .23
Confidence Interval (2-Sided) 95%
.13 to .34
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Z-score for Executive Function.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.
Arm/Group Title Eslicarbazepine Carbamazepine
Hide Arm/Group Description:
Eslicarbazepine Acetate (800mg once daily).
Carbamazepine (400mg twice daily).
Overall Number of Participants Analyzed 12 11
Mean (Standard Deviation)
Unit of Measure: Z-score
.22  (.53) -.32  (.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Eslicarbazepine, Carbamazepine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < .001
Comments [Not Specified]
Method t-test, 2 sided
Comments Degrees of freedom = 22.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .54
Confidence Interval (2-Sided) 95%
.30 to .79
Estimation Comments [Not Specified]
3.Secondary Outcome
Title MCG Paragraph Recall Scores.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.
Arm/Group Title Non-drug Condition Average Eslicarbazepine Carbamazepine
Hide Arm/Group Description:
Average of scores prior to treatment 1 and treatment 2.
Eslicarbazepine Acetate (800mg once daily).
Carbamazepine (400mg twice daily).
Overall Number of Participants Analyzed 23 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Immediate Recall 34  (17) 33  (12) 31  (15)
Delayed Recall 33  (18) 31  (13) 30  (16)
4.Secondary Outcome
Title Dual Task Percent of Time in Box.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.
Arm/Group Title Non-drug Condition Average Eslicarbazepine Carbamazepine
Hide Arm/Group Description:
Average of scores prior to treatment 1 and treatment 2.
Eslicarbazepine Acetate (800mg once daily).
Carbamazepine (400mg twice daily).
Overall Number of Participants Analyzed 23 12 11
Mean (Standard Deviation)
Unit of Measure: percentage of time in box
62  (33) 62  (33) 60  (34)
5.Secondary Outcome
Title Profile of Mood States (POMS) Score.
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.
Arm/Group Title Non-drug Condition Average Eslicarbazepine Carbamazepine
Hide Arm/Group Description:
Average of scores prior to treatment 1 and treatment 2.
Eslicarbazepine Acetate (800mg once daily).
Carbamazepine (400mg twice daily).
Overall Number of Participants Analyzed 23 12 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
8  (25) 11  (29) 15  (32)
Time Frame Up to 21 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eslicarbazepine Carbamazepine
Hide Arm/Group Description Eslicarbazepine Acetate (800mg once daily). Carbamazepine (400mg twice daily).
All-Cause Mortality
Eslicarbazepine Carbamazepine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Eslicarbazepine Carbamazepine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Eslicarbazepine Carbamazepine
Affected / at Risk (%) Affected / at Risk (%)
Total   12/29 (41.38%)   21/30 (70.00%) 
Gastrointestinal disorders     
Constipation   1/29 (3.45%)  1/30 (3.33%) 
Dry mouth   0/29 (0.00%)  2/30 (6.67%) 
Nausea   1/29 (3.45%)  2/30 (6.67%) 
Upset stomach   0/29 (0.00%)  1/30 (3.33%) 
Vomiting   0/29 (0.00%)  1/30 (3.33%) 
General disorders     
Fatigue   10/29 (34.48%)  9/30 (30.00%) 
Hunger   1/29 (3.45%)  0/30 (0.00%) 
Nervous system disorders     
Agitation   0/29 (0.00%)  1/30 (3.33%) 
Altered pitch perception (pitch seemed lower)   0/29 (0.00%)  1/30 (3.33%) 
Clouded vision   1/29 (3.45%)  0/30 (0.00%) 
Coordination/balance problems   0/29 (0.00%)  1/30 (3.33%) 
Difficulty naming objects   0/29 (0.00%)  1/30 (3.33%) 
Disorientation   0/29 (0.00%)  1/30 (3.33%) 
Dizziness   0/29 (0.00%)  4/30 (13.33%) 
Drowsiness   0/29 (0.00%)  2/30 (6.67%) 
Grogginess   0/29 (0.00%)  1/30 (3.33%) 
Headache   3/29 (10.34%)  3/30 (10.00%) 
Headache (mild)   0/29 (0.00%)  1/30 (3.33%) 
Hot Flashes   0/29 (0.00%)  1/30 (3.33%) 
Lightheadedness   0/29 (0.00%)  2/30 (6.67%) 
Loopy Feeling   0/29 (0.00%)  1/30 (3.33%) 
Loss of taste   0/29 (0.00%)  1/30 (3.33%) 
Memory problems   1/29 (3.45%)  1/30 (3.33%) 
Minor muscle twitch in hands   0/29 (0.00%)  1/30 (3.33%) 
Sleepiness   0/29 (0.00%)  1/30 (3.33%) 
Twitching   0/29 (0.00%)  1/30 (3.33%) 
Visual Illusions   0/29 (0.00%)  1/30 (3.33%) 
Skin and subcutaneous tissue disorders     
Rash   1/29 (3.45%)  2/30 (6.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kimford Meador
Organization: Stanford University
Phone: 650-725-6648
EMail: kmeador@stanford.edu
Layout table for additonal information
Responsible Party: Kimford Jay Meador, Stanford University
ClinicalTrials.gov Identifier: NCT02912364     History of Changes
Other Study ID Numbers: 34098
First Submitted: September 14, 2016
First Posted: September 23, 2016
Results First Submitted: March 20, 2019
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019