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Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) (COPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01891890
Recruitment Status : Terminated (Poor recruitment)
First Posted : July 3, 2013
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
David Loring, PhD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Epilepsy, Partial
Epilepsy, Localization Related
Interventions Drug: Oxcarbazepine
Drug: Levetiracetam
Drug: Lamotrigine
Enrollment 72
Recruitment Details Participants were recruited from 14 pediatric practices in the United States of America between August 2013 and October 2015.
Pre-assignment Details In total, 78 individuals consented to participate in the trial. Of these 6 were found to be ineligible or declined to participate prior to receiving the intervention, resulting in 72 participants who received the study intervention.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Period Title: Overall Study
Started 24 27 21
Completed 17 24 14
Not Completed 7 3 7
Reason Not Completed
Lost to Follow-up             0             0             1
Study ended before endpoint reached             7             3             6
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam Total
Hide Arm/Group Description Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses Total of all reporting groups
Overall Number of Baseline Participants 24 27 21 72
Hide Baseline Analysis Population Description
Patients who were eligible to participate and were randomized to a study arm are included in the baseline description.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 21 participants 72 participants
<=18 years
24
 100.0%
27
 100.0%
21
 100.0%
72
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 27 participants 21 participants 72 participants
8.6  (2.0) 8.6  (2.4) 9.1  (2.1) 8.7  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 21 participants 72 participants
Female
13
  54.2%
12
  44.4%
11
  52.4%
36
  50.0%
Male
11
  45.8%
15
  55.6%
10
  47.6%
36
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants 27 participants 21 participants 72 participants
24
 100.0%
27
 100.0%
21
 100.0%
72
 100.0%
1.Primary Outcome
Title Conners' Continuous Performance Test II (CPT-II) Confidence Index
Hide Description The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter "X". For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the CPT-II.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 24 26 20
Mean (Standard Deviation)
Unit of Measure: Confidence Index
Baseline Number Analyzed 24 participants 26 participants 20 participants
58.4  (20.0) 56.7  (21.6) 56.9  (23.9)
After 6 months of treatment Number Analyzed 17 participants 22 participants 14 participants
58.1  (23.2) 54.2  (21.7) 54.0  (24.4)
2.Secondary Outcome
Title Child Behavior Checklist
Hide Description The Child Behavior Checklist is a measure of specific behavioral and emotional problems are rated by the child's parent or guardian. The Child Behavior Checklist examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 118 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True). Total raw scores are converted to t-scores with a mean of 50 and standard deviation of 10. A t-score of 67 or greater is considered to be in the clinical range for problematic behavior.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Child Behavior Checklist.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 22 26 18
Mean (Standard Deviation)
Unit of Measure: t-scores
Baseline Number Analyzed 22 participants 26 participants 18 participants
37.6  (9.9) 39.8  (10.2) 38.2  (10.3)
After 6 months of treatment Number Analyzed 16 participants 21 participants 12 participants
37.5  (9.6) 36.7  (11.1) 33.3  (9.1)
3.Other Pre-specified Outcome
Title Wechsler Intelligence Scale for Children-IV Processing Speed
Hide Description Coding and Symbol Search subtests from the Wechsler Intelligence Scale for Children (WISC)-IV are measures of processing speed and combine to form the Processing Speed Index. Processing speed refers to how quickly the child understands and responds to information. Coding presents children with a row of boxes containing a numeral in the top line and a symbol in the bottom line with the task of copying the symbol corresponding to each numeral as quickly as possible in 120 seconds. In Symbol Search, children are given rows of symbols and target symbols and are asked to mark whether or not the target symbols appear in each row as quickly as possible during 120 seconds. Composite scores compare the test-taker to peers with a mean score of 100 and a standard deviation of 15. Possible scores range from 40 to 160 with higher scores indicating increased processing speeds. Scores between 85 and 115 are considered average, with 2/3 of test takers falling between these values.
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the WISC-IV.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 23 27 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 23 participants 27 participants 19 participants
87.8  (12.1) 97.9  (15.5) 102.1  (12.3)
After 3 months of treatment Number Analyzed 23 participants 18 participants 14 participants
95.7  (16.7) 90.4  (12.7) 96.9  (14.0)
After 6 months of treatment Number Analyzed 15 participants 23 participants 12 participants
97.3  (20.8) 101.22  (19.1) 102.6  (13.8)
4.Other Pre-specified Outcome
Title Story Memory
Hide Description Story Memory will be measured at baseline with the Children's Memory Scale (CMS) and then with the Wide Range Assessment of Memory and Learning-2 (WRAML-2) at the 6 month follow up visit. Two different tests are used to avoid practice effects in memory assessment associated with repeated assessments using the same stimulus material. The Story Memory sub-test of the CMS and the WRAML-2 Story Memory are measures of prose passage recall. Stories are read to the subject for recall, with different stories presented based upon participant age. Scores are converted to percentile ranks for both measurements of story memory. Possible scores can fall between the 1st and 99th percentile and higher values indicate better performance with story recall. Values between the 9th and 25 percentiles are considered "low average", values between the 25th and 75th percentiles are "average", while values between the 75th and 91st percentile are "high average".
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Story Memory measurement.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 22 26 20
Mean (Standard Deviation)
Unit of Measure: percentiles
Baseline (CMS) Number Analyzed 22 participants 26 participants 20 participants
29.6  (16.2) 31.2  (17.0) 29.4  (12.2)
After 6 months of treatment (WRAML-2) Number Analyzed 15 participants 23 participants 13 participants
23.1  (13.9) 26.1  (13.7) 26.5  (9.3)
5.Other Pre-specified Outcome
Title Symbol Digit Modalities Test
Hide Description Symbol Digit Modalities Test (SDMT) is a test of graphomotor speed using numbers as the response rather than copying symbols, and is timed at 90 seconds. The SDMT is designed for people who are 8 years of age and older and detects brain dysfunction as well as measures function over time. Possible total scores range from 0 to 110; where 110 indicates that all values were entered within the 90 second limit. An increase between initial and retest scores indicates that the respondent is correctly matching numbers to symbols at a faster speed. The SDMT was administered at the Month 3 and Month 6 visits for this study.
Time Frame Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Participants who were 8 years old or older were eligible to complete the Symbol Digit Modalities Test.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 10 15 9
Mean (Standard Deviation)
Unit of Measure: number of correct responses
After 3 months of treatment Number Analyzed 10 participants 13 participants 9 participants
25.9  (10.3) 28.5  (10.3) 23.0  (9.4)
After 6 months of treatment Number Analyzed 9 participants 15 participants 6 participants
26.4  (11.3) 30.4  (12.3) 28.3  (8.6)
6.Other Pre-specified Outcome
Title Grooved Pegboard
Hide Description The Grooved Pegboard assesses fine motor speed and dexterity. The participant fits keyhole-shaped pegs into similarly shaped holes on a square board. The pegs, which have an edge along one side, must be rotated to match the holes before they can be inserted. The scores represent the number of seconds it took for the participant to correctly insert the pegs into the require number of grooves, using their dominant hand.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Grooved Pegboard task.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 21 26 20
Mean (Standard Deviation)
Unit of Measure: Seconds
Baseline Number Analyzed 21 participants 26 participants 20 participants
99.9  (24.8) 96.3  (24.0) 114.2  (36.2)
After 6 months of treatment Number Analyzed 15 participants 23 participants 13 participants
90.3  (34.7) 90.1  (24.2) 94.9  (19.7)
7.Other Pre-specified Outcome
Title The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description Suicidal behaviors and suicidal ideation were assessed through an interview using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS guides interviewers to ask a series of simple questions in order to identify people at risk for suicide, as well as the severity and urgency of suicidal thoughts and behaviors. The Children's Baseline/Screening C-SSRS was used at the initial study visit while the Children's Since Last Visit C-SSRS was used for subsequent study visits. Any responses of "yes" to the C-SSRS questions are considered a positive response, indicating that the participant is experiencing thoughts of suicide or has exhibited suicidal behaviors.
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the C-SSRS.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 23 27 20
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 23 participants 27 participants 20 participants
0
   0.0%
0
   0.0%
0
   0.0%
After 3 months of treatment Number Analyzed 20 participants 21 participants 15 participants
0
   0.0%
0
   0.0%
0
   0.0%
After 6 months of treatment Number Analyzed 20 participants 21 participants 15 participants
0
   0.0%
0
   0.0%
0
   0.0%
8.Other Pre-specified Outcome
Title Youth Self Report
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
As this study was terminated early, the scoring algorithm was not programmed for this outcome measure.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Affective Reactivity Scale
Hide Description The Affective Reactivity Scale is a 7-item survey completed by the child participants which asks questions concerning their level of agreement with statements about anger and irritability. Respondents select between "not true" (scored as 0), "somewhat true" (scored as 1), and "certainly true (scored as 2). Total scores range from 0 to 14 with higher values indicating increased feelings of annoyance and anger.
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Affective Reactivity Scale.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 24 27 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 27 participants 21 participants
9.2  (2.5) 8.6  (2.7) 8.6  (2.2)
After 3 months of treatment Number Analyzed 21 participants 23 participants 15 participants
8.8  (2.5) 8.5  (2.0) 10.3  (3.1)
After 6 months of treatment Number Analyzed 16 participants 24 participants 15 participants
8.8  (3.0) 8.2  (2.7) 10.3  (3.2)
10.Other Pre-specified Outcome
Title Pediatric Neuro-QOL Score
Hide Description The Pediatric Neuro-QOL is a Quality of Life instrument developed in conjunction with NIH with a pediatric specific form utilized in this protocol. Pediatric Neuro-QOL assesses the domains of Anger, Anxiety, Cognition, Depression, Fatigue, Pain, Social Relations, and Stigma. Each domain has 8 to 10 items and respondents indicate how often they experienced feelings and circumstances related to each domain on a scale of 1 to 5 (such as 1=never, 2=almost never, 3=sometimes, 4=often, 5=almost always). Higher values indicate increased difficulty for most of the scales but this pattern is reversed for two of the domains. Raw scores are rescaled to standardized scores with a mean of 50 and a standard deviation of 10. Higher values for the standardized scores indicate more problematic characteristics while scores below 50 indicate that the child is experiencing less trouble in the domains measured by the Pediatric Neuro-QOL.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. This survey was completed by children aged 10 and older.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 14 15 11
Mean (Standard Deviation)
Unit of Measure: t-scores
Baseline Number Analyzed 14 participants 15 participants 11 participants
37.0  (6.0) 39.9  (9.6) 38.8  (5.6)
After 6 months of treatment Number Analyzed 8 participants 14 participants 7 participants
36.7  (8.2) 35.2  (5.2) 36.9  (5.3)
11.Other Pre-specified Outcome
Title Parenting Stress Inventory Short Form (PSI-4-SF)
Hide Description The Parenting Stress Inventory-4-Short Form is a 36 item questionnaire, completed by the parent/guardian, designed to evaluate parenting and family characteristics based upon child characteristics (behavioral and emotional problems), parent characteristics, and situational/demographic life stress. Respondents indicate the degree to which they agree with a variety of statements by selecting 1=strongly agree, 2=agree, 3=not sure, 4=disagree, or 5=strongly disagree. Raw scores range from 36 to 180 and higher scores are associated with higher parental stress.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the PSI-4-SF.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 22 22 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 22 participants 22 participants 20 participants
138.2  (21.0) 138.3  (17.5) 143.9  (20.4)
After 6 months of treatment Number Analyzed 17 participants 22 participants 12 participants
147.4  (20.9) 137.6  (24.3) 146.8  (22.3)
12.Other Pre-specified Outcome
Title Pediatric Inventory for Parents
Hide Description The Pediatric Inventory for Parents consists of 42 items involving communication, medical care, emotional disturbance, and change in role function. Parents respond to a list of difficult events (such as "difficulty sleeping") that are often experienced by parents of children who are seriously ill. Parents indicated how frequently an event occurred by selecting 1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Very often. Raw score values range from 4 to 210 with higher scores indicating increased frequency of difficult events.
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the Pediatric Inventory for Parents.
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description:
Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
Overall Number of Participants Analyzed 24 25 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 24 participants 25 participants 21 participants
93.0  (21.5) 98.4  (33.2) 91.1  (29.9)
After 6 months of treatment Number Analyzed 17 participants 21 participants 13 participants
74.2  (20.3) 76.5  (32.0) 74.8  (17.6)
Time Frame Information about adverse events experienced by participants was collected from the time the participant began taking the randomized study drug through 30 days after the last study visit.
Adverse Event Reporting Description An adverse event (AE) is an unfavorable and unintended diagnosis, sign, symptom, or disease temporarily associated with the study intervention. Serious adverse events (SAEs) are untoward medical occurrence resulting in death, are life-threatening, require or prolong hospitalization, cause disability/incapacity, result in birth defects, or represent other significant hazards. For this study, elective hospitalizations unrelated to epilepsy will not be considered SAEs.
 
Arm/Group Title Lamotrigine Oxcarbazepine Levetiracetam
Hide Arm/Group Description Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses
All-Cause Mortality
Lamotrigine Oxcarbazepine Levetiracetam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/27 (0.00%)   0/21 (0.00%) 
Hide Serious Adverse Events
Lamotrigine Oxcarbazepine Levetiracetam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/27 (0.00%)   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamotrigine Oxcarbazepine Levetiracetam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/27 (0.00%)   0/21 (0.00%) 
The study was terminated early due to inability to meet enrollment goals.
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: David Loring, PhD
Organization: Emory University
Phone: 404-778-5943
EMail: dloring@emory.edu
Layout table for additonal information
Responsible Party: David Loring, PhD, Emory University
ClinicalTrials.gov Identifier: NCT01891890    
Other Study ID Numbers: IRB00066541
PCORI 527 ( Other Grant/Funding Number: PCORI )
First Submitted: June 28, 2013
First Posted: July 3, 2013
Results First Submitted: July 14, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017