Trial Outcomes & Findings for Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults (NCT NCT02912364)
NCT ID: NCT02912364
Last Updated: 2019-06-04
Results Overview
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.
COMPLETED
PHASE4
46 participants
At the end of each 6-week drug treatment period.
2019-06-04
Participant Flow
Participant milestones
| Measure |
Eslicarbazepine, Then Carbamazepine
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.
|
Carbamazepine, Then Eslicarbazepine
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.
|
|---|---|---|
|
Treatment 1
STARTED
|
23
|
23
|
|
Treatment 1
Received Intervention
|
18
|
18
|
|
Treatment 1
COMPLETED
|
13
|
11
|
|
Treatment 1
NOT COMPLETED
|
10
|
12
|
|
Washout Period
STARTED
|
13
|
11
|
|
Washout Period
COMPLETED
|
13
|
11
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
|
Treatment 2
STARTED
|
13
|
11
|
|
Treatment 2
Received Intervention
|
12
|
11
|
|
Treatment 2
COMPLETED
|
12
|
11
|
|
Treatment 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Baseline characteristics by cohort
| Measure |
All Participants
n=46 Participants
Participants who received either Eslicarbazepine Acetate (800mg once daily), or Carbamazepine, 400mg twice daily.
|
|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
24 Participants
n=93 Participants
|
|
Education Level
|
15.0 years
STANDARD_DEVIATION 1.9 • n=93 Participants
|
|
IQ Estimate
|
98.6 units on a scale
STANDARD_DEVIATION 12.2 • n=93 Participants
|
PRIMARY outcome
Timeframe: At the end of each 6-week drug treatment period.Population: 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.
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.
Outcome measures
| Measure |
Eslicarbazepine
n=12 Participants
Eslicarbazepine Acetate (800mg once daily).
|
Carbamazepine
n=11 Participants
Carbamazepine (400mg twice daily).
|
Carbamazepine
Carbamazepine (400mg twice daily).
|
|---|---|---|---|
|
Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.
|
.001 Z-score
Standard Deviation .50
|
-.23 Z-score
Standard Deviation .61
|
—
|
SECONDARY outcome
Timeframe: At the end of each 6-week drug treatment period.Population: 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.
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.
Outcome measures
| Measure |
Eslicarbazepine
n=12 Participants
Eslicarbazepine Acetate (800mg once daily).
|
Carbamazepine
n=11 Participants
Carbamazepine (400mg twice daily).
|
Carbamazepine
Carbamazepine (400mg twice daily).
|
|---|---|---|---|
|
Overall Z-score for Executive Function.
|
.22 Z-score
Standard Deviation .53
|
-.32 Z-score
Standard Deviation .76
|
—
|
SECONDARY outcome
Timeframe: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.Population: 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.
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.
Outcome measures
| Measure |
Eslicarbazepine
n=23 Participants
Eslicarbazepine Acetate (800mg once daily).
|
Carbamazepine
n=12 Participants
Carbamazepine (400mg twice daily).
|
Carbamazepine
n=11 Participants
Carbamazepine (400mg twice daily).
|
|---|---|---|---|
|
MCG Paragraph Recall Scores.
Immediate Recall
|
34 units on a scale
Standard Deviation 17
|
33 units on a scale
Standard Deviation 12
|
31 units on a scale
Standard Deviation 15
|
|
MCG Paragraph Recall Scores.
Delayed Recall
|
33 units on a scale
Standard Deviation 18
|
31 units on a scale
Standard Deviation 13
|
30 units on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.Population: 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.
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.
Outcome measures
| Measure |
Eslicarbazepine
n=23 Participants
Eslicarbazepine Acetate (800mg once daily).
|
Carbamazepine
n=12 Participants
Carbamazepine (400mg twice daily).
|
Carbamazepine
n=11 Participants
Carbamazepine (400mg twice daily).
|
|---|---|---|---|
|
Dual Task Percent of Time in Box.
|
62 percentage of time in box
Standard Deviation 33
|
62 percentage of time in box
Standard Deviation 33
|
60 percentage of time in box
Standard Deviation 34
|
SECONDARY outcome
Timeframe: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.Population: 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.
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.
Outcome measures
| Measure |
Eslicarbazepine
n=23 Participants
Eslicarbazepine Acetate (800mg once daily).
|
Carbamazepine
n=12 Participants
Carbamazepine (400mg twice daily).
|
Carbamazepine
n=11 Participants
Carbamazepine (400mg twice daily).
|
|---|---|---|---|
|
Profile of Mood States (POMS) Score.
|
8 units on a scale
Standard Deviation 25
|
11 units on a scale
Standard Deviation 29
|
15 units on a scale
Standard Deviation 32
|
Adverse Events
Eslicarbazepine
Carbamazepine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eslicarbazepine
n=29 participants at risk
Eslicarbazepine Acetate (800mg once daily).
|
Carbamazepine
n=30 participants at risk
Carbamazepine (400mg twice daily).
|
|---|---|---|
|
Nervous system disorders
Agitation
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Altered pitch perception (pitch seemed lower)
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Clouded vision
|
3.4%
1/29 • Up to 21 weeks
|
0.00%
0/30 • Up to 21 weeks
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Coordination/balance problems
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Difficulty naming objects
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Disorientation
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • Up to 21 weeks
|
13.3%
4/30 • Up to 21 weeks
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/29 • Up to 21 weeks
|
6.7%
2/30 • Up to 21 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/29 • Up to 21 weeks
|
6.7%
2/30 • Up to 21 weeks
|
|
General disorders
Fatigue
|
34.5%
10/29 • Up to 21 weeks
|
30.0%
9/30 • Up to 21 weeks
|
|
Nervous system disorders
Grogginess
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Headache
|
10.3%
3/29 • Up to 21 weeks
|
10.0%
3/30 • Up to 21 weeks
|
|
Nervous system disorders
Headache (mild)
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Hot Flashes
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
General disorders
Hunger
|
3.4%
1/29 • Up to 21 weeks
|
0.00%
0/30 • Up to 21 weeks
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/29 • Up to 21 weeks
|
6.7%
2/30 • Up to 21 weeks
|
|
Nervous system disorders
Loopy Feeling
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Loss of taste
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Memory problems
|
3.4%
1/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Minor muscle twitch in hands
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Up to 21 weeks
|
6.7%
2/30 • Up to 21 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29 • Up to 21 weeks
|
6.7%
2/30 • Up to 21 weeks
|
|
Nervous system disorders
Sleepiness
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Twitching
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Nervous system disorders
Visual Illusions
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • Up to 21 weeks
|
3.3%
1/30 • Up to 21 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place