Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PCORI 527 | Other Grant/Funding Number | PCORI |
Not provided
Not provided
Poor recruitment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Seizures that arise in specific areas in the brain are called Localization Related Epilepsy (LRE) and are the most common seizure disorder in children. Children that receive drug treatment for this disorder may suffer from treatment related side effects which impact their ability to think or concentrate and their ability to interact socially. These negative treatment effects can impact the child's performance in school and long term may impact employment and job options.
This study will determine whether changes in attention and social interactions are seen in children treated for LRE using three of the most common medications used to treat pediatric LRE. Children who are newly diagnosed with LRE by their doctors and are between the ages of 5 years 6 months and 16 years 0 months will be randomized to receive levetiracetam, lamotrigine, or oxcarbazepine.
There will be 14 study sites throughout the US. Children will undergo evaluation of their thinking and ability to pay attention before and after starting drug treatment for LRE. Regardless of the specific findings, results of this study will provide the information needed to help parents and their clinicians choose treatment options that maximize cognitive abilities in children with LRE, and provide the data needed for practice guidelines to be established on the basis of cognitive side effect risks.
This is a prospective multicenter, randomized, open-label, central assessor, parallel-group study of children ages 5 years, 6 months to 16 years, 0 months with newly diagnosed Localization Related Epilepsy (LRE) to establish whether three common antiepileptic drugs (AEDs) used as first line LRE treatment (lamotrigine (LTG), levetiracetam (LEV), or oxcarbazepine (OXC)) are associated with differential cognitive side effects on attention. It is predicted that one AED will be identified with greater negative cognitive effects on attention. The study will also examine whether there are differential risks for drug-related behavior change. The study will address whether 6 month attentional outcomes can be reliably predicted based upon shorter term cognitive change assessed soon after beginning AED therapy, and establish practice effects associated with repeated test exposure when on constant doses of AED.
Children will undergo cognitive testing after study enrollment and no more than a week after AED initiation. Selected measures will be repeated at the first follow up clinic visit after beginning AED treatment, and the primary endpoint will be the attention performance obtained at the subjects' 6 month follow-up clinic visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine | Active Comparator | Lamotrigine 7.0 mg/kg tablets or chewable tablets administered daily in 2 equally divided doses |
|
| Oxcarbazepine | Active Comparator | Oxcarbazepine 25 mg/kg tablets or liquid administered daily in 2 equally divided doses |
|
| Levetiracetam | Active Comparator | Levetiracetam 30 mg/kg tablet or liquid administered daily in 2 equally divided doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxcarbazepine | Drug | Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Conners' Continuous Performance Test II (CPT-II) Confidence Index | 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. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior Checklist | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Intelligence Scale for Children-IV Processing Speed | 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. |
Inclusion Criteria:
Age of participant between 5 years, 6 months and 16 years, 0 months at the time of enrollment
Weight is between ≥ 15 kg the lower limit BMI 99th percentile at study entry at study entry
Child has diagnosed epilepsy as defined by one of the following definitions :
Child has a diagnosis of Localization Related Epilepsy (LRE) with or without secondary generalization according to International League Against Epilepsy (ILAE) criteria and which may include Benign Rolandic Epilepsy and Benign Occipital Epilepsy or other LREs.
Localization related seizures will be based upon at least one of the following: 1) focal EEG abnormalities (sharp waves, spikes, or slowing) and the absence of generalized spike waves discharges, 2) focal MRI abnormalities other than active cysticercosis, which may include temporal lobe sclerosis, dysembryoplastic neuroepithelial tumor , ganglioglioma, or focal malformations of cortical development, 3) focal neurologic abnormalities, or 4) clinical semiology, which may include Todd's phenomenon, unilateral dystonia, or fencing posture, or distinct aura consistent with localization related seizure onset (e.g., classic déjà vu or bad smell).
Participants must either be antiepileptic drug (AED) therapy naïve or on an AED (excluding benzodiazepines) for 1-week or less. Children may be on a stable dose of psychostimulants at the time of enrollment, but no change in medication, dose, or schedule in 3 months prior to study enrollment, with no anticipated dosing changes during the 6 months of the study. If participants are taking psychostimulants at the time of study entry, they should plan on continuing them for the 6 month duration of the study protocol including the 3-month and 6-month cognitive and behavioral testing time points.
Females of child bearing potential must agree to acceptable forms of birth control, which may include abstinence.
The child's parent/guardian must be able to keep an accurate seizure diary and be able and willing to comply with instructions and study procedures.
Informed consent from the child's legal guardian or legal representative.
Assent will be obtained from children according to each site's institutional guidelines.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David W. Loring, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72205 | United States | ||
| University of California at San Diego |
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.
Participants were recruited from 14 pediatric practices in the United States of America between August 2013 and October 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lamotrigine | Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses |
| FG001 | Oxcarbazepine | Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Levetiracetam | Drug | Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks. |
|
|
| Lamotrigine | Drug | Titration to target dose starting at week 11. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks. |
|
|
| Baseline, Month 6 |
| Baseline, Month 3, Month 6 |
| Story Memory | 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". | Baseline, Month 6 |
| Symbol Digit Modalities Test | 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. | Month 3, Month 6 |
| Grooved Pegboard | 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. | Baseline, Month 6 |
| The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Baseline, Month 3, Month 6 |
| Youth Self Report | 6 months |
| Affective Reactivity Scale | 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. | Baseline, Month 3, Month 6 |
| Pediatric Neuro-QOL Score | 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. | Baseline, Month 6 |
| Parenting Stress Inventory Short Form (PSI-4-SF) | 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. | Baseline, Month 6 |
| Pediatric Inventory for Parents | 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. | Baseline, Month 6 |
| San Diego |
| California |
| 92092 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Children's Healtcare of Atlanta | Atlanta | Georgia | 30342 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Rochester | Monroe | New York | 14642 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| FG002 | Levetiracetam | Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients who were eligible to participate and were randomized to a study arm are included in the baseline description.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lamotrigine | Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses |
| BG001 | Oxcarbazepine | Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses |
| BG002 | Levetiracetam | Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Conners' Continuous Performance Test II (CPT-II) Confidence Index | 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. | 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. | Posted | Mean | Standard Deviation | Confidence Index | Baseline, Month 6 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Child Behavior Checklist | 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. | 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. | Posted | Mean | Standard Deviation | t-scores | Baseline, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Wechsler Intelligence Scale for Children-IV Processing Speed | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Story Memory | 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". | 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. | Posted | Mean | Standard Deviation | percentiles | Baseline, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Symbol Digit Modalities Test | 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. | 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. | Posted | Mean | Standard Deviation | number of correct responses | Month 3, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Grooved Pegboard | 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. | 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. | Posted | Mean | Standard Deviation | Seconds | Baseline, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | 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. | Posted | Count of Participants | Participants | Baseline, Month 3, Month 6 |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Youth Self Report | As this study was terminated early, the scoring algorithm was not programmed for this outcome measure. | Posted | 6 months |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Affective Reactivity Scale | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Pediatric Neuro-QOL Score | 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. | The analysis includes participants who completed the assessment at the specified study visit. This survey was completed by children aged 10 and older. | Posted | Mean | Standard Deviation | t-scores | Baseline, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Parenting Stress Inventory Short Form (PSI-4-SF) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Pediatric Inventory for Parents | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6 |
|
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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lamotrigine | Participants who received lamotrigine 7.0 mg/kg tablets or chewable tablets daily, administered in 2 equally divided doses | 0 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Oxcarbazepine | Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Levetiracetam | Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses | 0 | 21 | 0 | 21 | 0 | 21 |
Not provided
Not provided
The study was terminated early due to inability to meet enrollment goals.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Loring, PhD | Emory University | 404-778-5943 | dloring@emory.edu |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| D000077287 | Levetiracetam |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014227 | Triazines |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| After 6 months of treatment |
|
|
| Levetiracetam |
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses |
|
|
Participants who received oxcarbazepine 25 mg/kg tablets or liquid daily, administered in 2 equally divided doses
| OG002 | Levetiracetam | Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses |
|
|
| OG002 | Levetiracetam | Participants who received levetiracetam 30 mg/kg tablet 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 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Levetiracetam |
Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses |
|
|
|
|
| OG002 | Levetiracetam | Participants who received levetiracetam 30 mg/kg tablet or liquid daily, administered in 2 equally divided doses |
|
|
|
|
|
|