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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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Double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eslicarbazepine | Experimental | Randomized to eslicarbazepine 800mg po bid in crossover design. |
|
| Carbamazepine | Experimental | Randomized to carbamazepine 400mg po bid in crossover design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimford Meador, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment 1 |
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| Washout Period |
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| Treatment 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants who received either Eslicarbazepine Acetate (800mg once daily), or Carbamazepine, 400mg twice daily. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Z-score | At the end of each 6-week drug treatment period. |
|
Up to 21 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eslicarbazepine | Eslicarbazepine Acetate (800mg once daily). | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimford Meador | Stanford University | 650-725-6648 | kmeador@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2017 | Mar 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C571001 | eslicarbazepine |
| C416835 | eslicarbazepine acetate |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
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| At the end of each 6-week drug treatment period. |
| 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. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. |
| 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. | Prior to treatment (non-drug condition average) and at the end of each six-week 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. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. |
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| COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Education Level | Education level is reported as the average number of years spent in school. | Mean | Standard Deviation | years |
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| IQ Estimate | IQ scores are generally interpreted as follows
| Mean | Standard Deviation | units on a scale |
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| OG001 | Carbamazepine | Carbamazepine (400mg twice daily). |
|
|
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Z-score | At the end of each 6-week drug treatment period. |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percentage of time in box | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. |
|
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| 29 |
| 0 |
| 29 |
| 12 |
| 29 |
| EG001 | Carbamazepine | Carbamazepine (400mg twice daily). | 0 | 30 | 0 | 30 | 21 | 30 |
| Altered pitch perception (pitch seemed lower) | Nervous system disorders | Systematic Assessment |
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| Clouded vision | Nervous system disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Coordination/balance problems | Nervous system disorders | Systematic Assessment |
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| Difficulty naming objects | Nervous system disorders | Systematic Assessment |
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| Disorientation | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Drowsiness | Nervous system disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Grogginess | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Headache (mild) | Nervous system disorders | Systematic Assessment |
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| Hot Flashes | Nervous system disorders | Systematic Assessment |
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| Hunger | General disorders | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Loopy Feeling | Nervous system disorders | Systematic Assessment |
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| Loss of taste | Nervous system disorders | Systematic Assessment |
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| Memory problems | Nervous system disorders | Systematic Assessment |
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| Minor muscle twitch in hands | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sleepiness | Nervous system disorders | Systematic Assessment |
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| Twitching | Nervous system disorders | Systematic Assessment |
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| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
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| Visual Illusions | Nervous system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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