Sturge-Weber Syndrome
Conditions
Keywords
Sturge-Weber Syndrome, SWS, Cognitive impairments
Brief summary
The purpose of this study is to better understand the utility of cannabidiol (CBD/ Epidiolex) for improving the treatment of cognitive impairments in Sturge-Weber syndrome (SWS).
Detailed description
The investigators hope to gain an understanding of the utility of pharmaceutical grade CBD used for the treatment of cognitive impairments in SWS in this open-label study. Anecdotal evidence from a phase I trial investigating the use of CBD for medically refractory seizures suggests CBD may also have a beneficial effect on cognition, mood, and behavior. The investigators hypothesize that CBD/ Epidiolex will improve SWS brain function resulting in improved cognitive function, social interactions, mood, motor function and behavior, as well as reduced migraines. This is an open-label prospective oral drug trial of Epidiolex in 10 subjects. Assessments will be done at baseline and repeated after 6 months on study drug.
Interventions
DRUGCannabidiol
Initiation of treatment will begin with 5 mg/kg/day given in two divided doses. The dose will be increased by 5 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 20 mg/kg/day given.
Sponsors
Jazz Pharmaceuticals
Faneca 66 Foundation
Anne Comi, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Participants with Sturge-Weber syndrome brain involvement as defined on neuroimaging (n=10 subjects, male and female, ages 3 to 50 years of age) and the following: * Cognitive impairment defined as a cognitive neuroscore greater than or equal to 2 at screening. * Anti-epileptic, mood or behavioral drugs (if on) at stable doses for a minimum of 4 weeks prior to enrollment. * If present, VNS must be on stable setting for a minimum of 3 months prior to enrollment. * If on ketogenic or Atkins diet, must be on stable ratio for a minimum of 3 months prior to enrollment. * Previous subjects who fail at any point to meet continuation criteria and withdraw early may be considered for re-enrollment under new subject ID as long as the above inclusion criteria are met. The determination of whether to re-enroll will be made by the PI and sponsor on a case-by-case basis. Re-enrollment can occur no earlier than 4 weeks after the final, post-weaning follow-up visit under the old subject ID. * Written informed consent obtained from the patient or the patient's legal representative must be obtained prior to beginning treatment.
Exclusion criteria
* Patients with any severe and/or uncontrolled medical conditions at randomization such as: 1. Liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) 2. Uncontrolled diabetes as defined by fasting serum glucose greater than 1.5 3. Active (acute or chronic) or uncontrolled severe infections 4. Active, bleeding diathesis * Patients who have a major surgery or significant traumatic injury within 4 weeks of study entry, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study. * Patients who start or discontinue a seizure, mood or behavioral medication in the 4 weeks leading up to screening. * Prior treatment with any investigational drug or use of any other cannabis product within the preceding 4 weeks prior to study entry. * Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study. This includes those in foster care, or those unable to keep follow-up appointments, maintain close contact with the Principal Investigator, or complete all necessary studies to maintain safety. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| List Sorting Working Memory Test | Baseline, Follow-up (6 months) | Data on cognitive function was collected using the List Sorting Working Memory Test from the NIH Toolbox. Data was collected on working memory performance, which was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure Frequency | Baseline, Follow-up (6 months) | Change in seizure frequency by seizure score at pre-treatment baseline and after six months. The seizure score is taken from the Sturge-Weber Neuroscore on a scale of 0 to 4 where 0=none, 1=1+. but controlled, 2=Breakthrough, 3=monthly, 4=Weekly+. Higher scores indicate worse outcome. |
| Migraine Severity | Baseline, Follow-up (6 months) | Data on migraine severity will be collected using patient responses to questions on a standard six-point scale. Data will be collected on the frequency of an event (e.g. feelings of frustration, performance of daily activities) which will be transformed into a score from 0 to 100 where higher scores indicate a less migraine severity and better outcomes. Data will be collected at baseline and after 6 months on study drug. |
| Modified House Classification Scores | Baseline, Follow-up (6 months) | Data on motor function was collected using a Modified House Classification. Data was collected on the ability to complete a task with the subject's non-dominant hand which was transformed into a score from 1 to 8 and 0 to 32 where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. |
| Erhardt Developmental Prehension Assessment Scores | Baseline, Follow-up (6 months) | Data on motor function was collected using the Erhardt Developmental Prehension assessment. Data was collected on the ability to complete a task with each hand, which was scored as age equivalence of task performance (in months). Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. |
| Pediatric Evaluation of Disability Inventory Computer Adapted Test | Baseline, Follow-up (6 months) | Data on motor function was collected using the Pediatric Evaluation of Disability Inventory Computer Adapted Test. Data was collected on the subject's ability to complete tasks involved in daily activities, mobility, and social/ cognitive activities. The data was transformed into scaled scores ranging from 20 to 80, where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. |
| ABILHAND Questionnaire | Baseline, Follow-up (6 months) | Data on motor function was collected using the ABILHAND questionnaire, a measure of manual ability for adults with upper limb impairments. Data was collected on the subject's ability to complete daily activities that involve the upper limbs. Score was collected as a patient measure with scores ranging from -10 to 10. Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug. |
| Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Baseline, Follow-up (6 months) | Data on cognitive function was collected using selected subtests, from either the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale (WAIS-IV). For the WISC-V and WAIS-IV subtests selected, scaled scores were derived from the normative data which account for age and demographic information. The selected WISC-V/WAIS-IV subtests were as follows: Digit Span, Symbol Search, Coding and Processing Speed; the first three subtests were scored from 0-10, the fourth subtest from 0-100, and for all subtests higher score is better. The selected subtests, from the WISC-V and the WAIS-IV, were combined to increase statistical power. Statistically rare changes in individual test scores were determined using a reliable change index methodology based upon normative information for these assessments. |
| Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline, Follow-up (6 months) | Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event (e.g. forgetting schoolwork) was collected and transformed into a t-score from 0 to 100 where higher t-scores indicate worse anger, worse anxiety, worse pain, better social relationships, worse stigma, worse depression, better cognitive function, and worse fatigue. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug. |
| Picture Vocabulary Test | Baseline, Follow-up (6 months) | Data on cognitive function was collected using the Picture Vocabulary subtest from the NIH Toolbox. Single words are presented via an audio file, paired simultaneously with 4 screen images of objects, actions, and/or depictions of concepts. The task is to pick the picture that matches the spoken word. Performance on the task was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug. |
| Social Responsiveness Scale, Second Edition (SRS-2) | Baseline, Follow-up (6 months) | Data on social function was collected using the Social Responsiveness Scale-Second Edition (SRS-2). Data on a child's ability to engage in emotionally appropriate reciprocal social interactions in naturalistic settings was collected and transformed into a t-score from 0 to 100 where higher scores indicate greater impairment in social function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug. |
| Behavioral Assessment System for Children, Third Edition (BASC-3) | Baseline, Follow-up (6 months) | Data on behavioral function was collected using the Behavioral Assessment System for Children, Third Edition (BASC-3). Data on the frequency of a behavior (e.g. avoids eye contact) was collected and transformed into a t-score. Subscales for the BASC-3 scored were: External Problems Composite, the Internal Problems Composite, the Behavioral Symptoms Index, and the Adaptive Skills Composite. For the first three subscales, lower t-score indicates better outcome; for the fourth, a lower t-score indicates worse outcome. T-scores for all the BASC-3 subscales range from 0 to 100, and a t-score of 50 indicates the population mean with a standard deviation of 10. |
| Screen for Child Anxiety Related Disorders (SCARED) | Baseline, Follow-up (6 months) | Data on anxiety was collected using the Screen for Child Anxiety Related Disorders (SCARED). Data on the truthfulness of a statement (e.g. I am nervous) was collected and transformed into a score from 0 to 82 where higher scores indicate greater anxiety. Data was collected at baseline and 6 months on study drug. |
| Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) | Baseline, Follow-up (6 months) | Data on quality of life was collected using the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55). Data on the frequency of an event (e.g. had trouble concentrating on a task) was collected and transformed into a score from 0 to 100 where higher scores reflect better quality of life. Data was collected at baseline and 6 months on study drug. |
| Safety of Epidiolex | Baseline, Follow-up (6 months) | Safety of Epidiolex was measured by the number of adverse events and serious adverse events that result from study drug. |
| Neuroscore | Baseline, Follow-up (6 months) | Data on neurological function was collected using the Neuroscore. Data on frequency of seizures, extent of hemiparesis, assessment of visual field cut, and degree of cognitive functioning was transformed into a score from 0 to 15 where higher scores indicate worse neurologic function. Data was collected at baseline and 6 months on study drug. |
| Port-wine Birthmark Score | Baseline, Follow-up (6 months) | Data on facial port-wine birthmarks was collected using the Port-wine Birthmark Score. Data on percent of face covered, thickness of birthmark, and darkness of birthmark color was collected and transformed into a score from 0 to 43 where higher scores indicate greater severity and greater surface area involved. Data was collected at baseline and 6 months on study drug. |
| Adult Neurological Quality of Life (Neuro-QoL) | Baseline, Follow-up (6 months) | Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event was collected and transformed into a t-score from 0 to 100. Higher t-scores indicate better communication, better ability to participate in social activity, worse anxiety, worse depression, worse emotional and behavioral dyscontrol, worse fatigue, better positive affect, worse sleep disturbance, better lower and upper extremity functions, worse stigma, better satisfaction with social roles, and better cognitive function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug. |
| Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline, Follow-up (6 months) | Data on executive function was collected using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). Data on the frequency of an event (e.g. becomes upset too easily) was collected and transformed into a t-score. The following BRIEF-2 subtests were evaluated: Behavioral Regulation Index, Emotional Regulation Index, Cognitive Regulation Index, and Global Executive Composite. For each BRIEF-2 subtest, t-scores range from 0 to 100; a score of 50 indicates the population mean with a standard deviation of 10. For all BASC-3 subtests, higher scores are worse outcome. |
Countries
United States
Participant flow
Pre-assignment details
After consent, subject 10 was not enrolled as they did not meet the inclusion criteria of remaining at a stable does of anti-epileptic drugs 4 weeks prior to enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Cannabidiol Subjects took oral cannabidiol for 6 months (doses ranged from 5 mg/kg/day to 20 mg/kg/day). Neuropsychological, psychiatrics and motor assessments were administered at baseline and six months follow-up. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrew due to moderate side effects (fatigue) | 1 |
Baseline characteristics
| Characteristic | Cannabidiol |
|---|---|
| Age, Continuous | 13.83 years STANDARD_DEVIATION 9.67 |
| Brain Involvement Bilateral Brain Involvement | 2 Participants |
| Brain Involvement Left-Sided Brain Involvement | 2 Participants |
| Brain Involvement Right-Sided Brain Involvement | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Eye Involvement Bilateral Eye Involvement | 1 Participants |
| Eye Involvement Left-Sided Eye Involvement | 2 Participants |
| Eye Involvement No Eye Involvement | 3 Participants |
| Eye Involvement Right-Sided Eye Involvement | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
| Skin Involvement Bilateral Skin Involvement | 4 Participants |
| Skin Involvement Left-Sided Skin Involvement | 2 Participants |
| Skin Involvement Right-Sided Skin Involvement | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
List Sorting Working Memory Test
Data on cognitive function was collected using the List Sorting Working Memory Test from the NIH Toolbox. Data was collected on working memory performance, which was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 1 was unable to complete this assessment due to lack of understanding of the instructions. Subject 10 was unable to complete this assessment due to a system error, where the fully adjusted score was not obtained. Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | List Sorting Working Memory Test | Baseline List Sorting Working Memory Fully Adjusted Score | 37.14 T-score | Standard Deviation 10.92 |
| Cannabidiol/ Epidiolex | List Sorting Working Memory Test | Follow-Up List Sorting Working Memory Fully Adjusted Score | 39.14 T-score | Standard Deviation 13.78 |
Secondary
ABILHAND Questionnaire
Data on motor function was collected using the ABILHAND questionnaire, a measure of manual ability for adults with upper limb impairments. Data was collected on the subject's ability to complete daily activities that involve the upper limbs. Score was collected as a patient measure with scores ranging from -10 to 10. Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 7 misplaced this questionnaire and was not included in analysis. Subject 9 was withdrawn prior to the 6 month follow-up visit due to persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | ABILHAND Questionnaire | Follow-up Mean of the ABILHAND | 2.88 score on a scale | Standard Deviation 1.39 |
| Cannabidiol/ Epidiolex | ABILHAND Questionnaire | Baseline Mean of the ABILHAND | 1.81 score on a scale | Standard Deviation 1.98 |
Secondary
Adult Neurological Quality of Life (Neuro-QoL)
Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event was collected and transformed into a t-score from 0 to 100. Higher t-scores indicate better communication, better ability to participate in social activity, worse anxiety, worse depression, worse emotional and behavioral dyscontrol, worse fatigue, better positive affect, worse sleep disturbance, better lower and upper extremity functions, worse stigma, better satisfaction with social roles, and better cognitive function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subjects above the age of 18 completed the pediatric version of this questionnaire and were included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Anxiety | 46.77 T-score | Standard Deviation 13.33 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Anxiety | 46.87 T-score | Standard Deviation 6.45 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Depression | 42.70 T-score | Standard Deviation 10.05 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Depression | 44.23 T-score | Standard Deviation 9.53 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Fatigue | 45.23 T-score | Standard Deviation 9.53 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Fatigue | 42.80 T-score | Standard Deviation 4.6 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Upper Extremity Function | 48.97 T-score | Standard Deviation 8.37 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Upper Extremity Function | 53.80 T-score | Standard Deviation 0 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Lower Extremity Function | 58.60 T-score | Standard Deviation 0 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Lower Extremity Function | 58.60 T-score | Standard Deviation 0 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Cognitive Function | 47.03 T-score | Standard Deviation 15.52 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Cognitive Function | 46.73 T-score | Standard Deviation 5.01 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Emotional and Behavioral Dyscontrol | 51.10 T-score | Standard Deviation 14.97 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Emotional and Behavioral Dyscontrol | 41.37 T-score | Standard Deviation 9.98 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Well-being | 54.30 T-score | Standard Deviation 4.91 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Well-being | 55.70 T-score | Standard Deviation 6.59 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Sleep Disturbances | 47.03 T-score | Standard Deviation 7.49 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Sleep Disturbances | 43.93 T-score | Standard Deviation 4.9 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Participation in Social Activities | 53.00 T-score | Standard Deviation 7.41 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Participation in Social Activities | 51.03 T-score | Standard Deviation 8.01 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Satisfaction in Social Activities | 47.70 T-score | Standard Deviation 3.28 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Satisfaction in Social Activities | 49.23 T-score | Standard Deviation 2.54 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Baseline Mean Adult Score for Stigma | 53.90 T-score | Standard Deviation 8.8 |
| Cannabidiol/ Epidiolex | Adult Neurological Quality of Life (Neuro-QoL) | Follow-Up Mean Adult Score for Stigma | 56.47 T-score | Standard Deviation 6.25 |
Secondary
Behavioral Assessment System for Children, Third Edition (BASC-3)
Data on behavioral function was collected using the Behavioral Assessment System for Children, Third Edition (BASC-3). Data on the frequency of a behavior (e.g. avoids eye contact) was collected and transformed into a t-score. Subscales for the BASC-3 scored were: External Problems Composite, the Internal Problems Composite, the Behavioral Symptoms Index, and the Adaptive Skills Composite. For the first three subscales, lower t-score indicates better outcome; for the fourth, a lower t-score indicates worse outcome. T-scores for all the BASC-3 subscales range from 0 to 100, and a t-score of 50 indicates the population mean with a standard deviation of 10.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Baseline Mean External Problems Composite | 51.22 T-score | Standard Deviation 6.1 |
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Follow-up Mean External Problems Composite | 50.11 T-score | Standard Deviation 6.31 |
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Baseline Mean Internal Problems Composite | 52.22 T-score | Standard Deviation 5.81 |
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Follow-Up Mean Internal Problems Composite | 46.22 T-score | Standard Deviation 7.17 |
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Baseline Mean Behavioral Symptoms Index | 54.22 T-score | Standard Deviation 4.21 |
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Follow-up Mean Behavioral Symptoms Index | 50.11 T-score | Standard Deviation 8.19 |
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Baseline Mean Adaptive Skills Composite | 45.00 T-score | Standard Deviation 8.29 |
| Cannabidiol/ Epidiolex | Behavioral Assessment System for Children, Third Edition (BASC-3) | Follow-Up Mean Adaptive Skills Composite | 48.44 T-score | Standard Deviation 7.63 |
Secondary
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)
Data on executive function was collected using the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2). Data on the frequency of an event (e.g. becomes upset too easily) was collected and transformed into a t-score. The following BRIEF-2 subtests were evaluated: Behavioral Regulation Index, Emotional Regulation Index, Cognitive Regulation Index, and Global Executive Composite. For each BRIEF-2 subtest, t-scores range from 0 to 100; a score of 50 indicates the population mean with a standard deviation of 10. For all BASC-3 subtests, higher scores are worse outcome.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline Mean for Behavioral Regulation Index | 55.11 T-score | Standard Deviation 11.66 |
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Follow-Up Mean for Behavioral Regulation Index | 52.44 T-score | Standard Deviation 13.6 |
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline Mean for Emotional Regulation Index | 60.22 T-score | Standard Deviation 10.24 |
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Follow-up Mean for Emotional Regulation Index | 51.22 T-score | Standard Deviation 12.29 |
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline Mean for Cognitive Regulation Index | 54.11 T-score | Standard Deviation 7.06 |
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Follow-up Mean for Cognitive Regulation Index | 54.22 T-score | Standard Deviation 10.59 |
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Baseline Mean for Global Executive Composite | 56.78 T-score | Standard Deviation 8.17 |
| Cannabidiol/ Epidiolex | Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) | Follow-up Mean for Global Executive Composite | 53.33 T-score | Standard Deviation 11.57 |
Secondary
Erhardt Developmental Prehension Assessment Scores
Data on motor function was collected using the Erhardt Developmental Prehension assessment. Data was collected on the ability to complete a task with each hand, which was scored as age equivalence of task performance (in months). Higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Erhardt Developmental Prehension Assessment Scores | Baseline Mean Dominant Hand Total Score | 54.22 Months | Standard Deviation 2.64 |
| Cannabidiol/ Epidiolex | Erhardt Developmental Prehension Assessment Scores | Follow-up Mean Dominant Hand Total Score | 53.56 Months | Standard Deviation 4.04 |
| Cannabidiol/ Epidiolex | Erhardt Developmental Prehension Assessment Scores | Baseline Mean Non-Dominant Hand Total Score | 51.22 Months | Standard Deviation 9.48 |
| Cannabidiol/ Epidiolex | Erhardt Developmental Prehension Assessment Scores | Follow-up Mean Non-Dominant Hand Total Score | 53.78 Months | Standard Deviation 4.15 |
Secondary
Migraine Severity
Data on migraine severity will be collected using patient responses to questions on a standard six-point scale. Data will be collected on the frequency of an event (e.g. feelings of frustration, performance of daily activities) which will be transformed into a score from 0 to 100 where higher scores indicate a less migraine severity and better outcomes. Data will be collected at baseline and after 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 7 misplaced this questionnaire and was not included in analysis. Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Migraine Severity | Baseline Mean Migraine-Quality of Life Score | 96.83 score on a scale | Standard Deviation 7.62 |
| Cannabidiol/ Epidiolex | Migraine Severity | Follow-up Mean Migraine-Quality of Life Score | 97.50 score on a scale | Standard Deviation 4.69 |
Secondary
Modified House Classification Scores
Data on motor function was collected using a Modified House Classification. Data was collected on the ability to complete a task with the subject's non-dominant hand which was transformed into a score from 1 to 8 and 0 to 32 where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Modified House Classification Scores | Baseline Mean Highest Category in Which All Items were Successfully Completed | 5.11 score on a scale | Standard Deviation 0.93 |
| Cannabidiol/ Epidiolex | Modified House Classification Scores | Follow-up Mean Highest Category in Which All Items were Successfully Completed | 5.44 score on a scale | Standard Deviation 1.33 |
| Cannabidiol/ Epidiolex | Modified House Classification Scores | Baseline Mean Total Number of Items Successfully Completed | 26.67 score on a scale | Standard Deviation 4.12 |
| Cannabidiol/ Epidiolex | Modified House Classification Scores | Follow-up Mean Total Number of Items Successfully Completed | 27.44 score on a scale | Standard Deviation 4.75 |
Secondary
Neuroscore
Data on neurological function was collected using the Neuroscore. Data on frequency of seizures, extent of hemiparesis, assessment of visual field cut, and degree of cognitive functioning was transformed into a score from 0 to 15 where higher scores indicate worse neurologic function. Data was collected at baseline and 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit and not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Neuroscore | Follow-up Mean Cognitive Function Score | 1.44 score on a scale | Standard Deviation 0.53 |
| Cannabidiol/ Epidiolex | Neuroscore | Baseline Mean Seizure Score | 1.11 score on a scale | Standard Deviation 0.33 |
| Cannabidiol/ Epidiolex | Neuroscore | Follow-Up Mean Seizure Score | 1.00 score on a scale | Standard Deviation 0 |
| Cannabidiol/ Epidiolex | Neuroscore | Baseline Mean Hemiparesis Score | 1.44 score on a scale | Standard Deviation 1.13 |
| Cannabidiol/ Epidiolex | Neuroscore | Follow-Up Mean Hemiparesis Score | 1.00 score on a scale | Standard Deviation 0.87 |
| Cannabidiol/ Epidiolex | Neuroscore | Baseline Mean Visual Field Cut Score | 0.11 score on a scale | Standard Deviation 0.33 |
| Cannabidiol/ Epidiolex | Neuroscore | Follow-Up Mean Visual Field Cut Score | 0.00 score on a scale | Standard Deviation 0 |
| Cannabidiol/ Epidiolex | Neuroscore | Baseline Mean Cognitive Function Score | 2.33 score on a scale | Standard Deviation 0.5 |
| Cannabidiol/ Epidiolex | Neuroscore | Baseline Mean Composite Score | 5.00 score on a scale | Standard Deviation 1.32 |
| Cannabidiol/ Epidiolex | Neuroscore | Follow-up Mean Composite Score | 3.44 score on a scale | Standard Deviation 0.88 |
Secondary
Pediatric Evaluation of Disability Inventory Computer Adapted Test
Data on motor function was collected using the Pediatric Evaluation of Disability Inventory Computer Adapted Test. Data was collected on the subject's ability to complete tasks involved in daily activities, mobility, and social/ cognitive activities. The data was transformed into scaled scores ranging from 20 to 80, where higher scores indicate better motor function. Data was collected at baseline and after 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Baseline Mean Score for Daily Activities | 58.67 score on a scale | Standard Deviation 7.76 |
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Follow-up Mean Score for Daily Activities | 60.00 score on a scale | Standard Deviation 6.5 |
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Baseline Mean Score for Mobility | 67.11 score on a scale | Standard Deviation 4.76 |
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Follow-Up Mean Score for Mobility | 68.56 score on a scale | Standard Deviation 4.07 |
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Follow-Up Mean Score for Responsibility | 53.89 score on a scale | Standard Deviation 11.1 |
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Baseline Mean Score for Social Cognitive | 66.89 score on a scale | Standard Deviation 5.35 |
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Follow-up Mean Score for Social Cognitive | 67.22 score on a scale | Standard Deviation 4.63 |
| Cannabidiol/ Epidiolex | Pediatric Evaluation of Disability Inventory Computer Adapted Test | Baseline Mean Score for Responsibility | 52.44 score on a scale | Standard Deviation 11.67 |
Secondary
Pediatric Neurological Quality of Life (Neuro-QoL)
Data on cognitive function was collected using Neurological Quality of Life scales from the NIH Toolbox. Data on frequency of an event (e.g. forgetting schoolwork) was collected and transformed into a t-score from 0 to 100 where higher t-scores indicate worse anger, worse anxiety, worse pain, better social relationships, worse stigma, worse depression, better cognitive function, and worse fatigue. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subjects below the age of 18 completed the pediatric version of this questionnaire and were included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Anger | 53.02 T-score | Standard Deviation 3.09 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Anger | 49.67 T-score | Standard Deviation 7 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Anxiety | 45.20 T-score | Standard Deviation 5.79 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Anxiety | 41.07 T-score | Standard Deviation 5.74 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Pain | 40.20 T-score | Standard Deviation 4.16 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Pain | 43.50 T-score | Standard Deviation 5.89 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Social Relations | 43.28 T-score | Standard Deviation 15.1 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Social Relations | 54.33 T-score | Standard Deviation 6.96 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Stigma | 42.45 T-score | Standard Deviation 6.42 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Stigma | 44.52 T-score | Standard Deviation 4.88 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Depression | 44.07 T-score | Standard Deviation 6.29 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Depression | 44.62 T-score | Standard Deviation 8.58 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Cognitive Function | 49.27 T-score | Standard Deviation 3.36 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Cognitive Function | 51.33 T-score | Standard Deviation 6.44 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Baseline Mean Pediatric Score for Fatigue | 46.38 T-score | Standard Deviation 9.44 |
| Cannabidiol/ Epidiolex | Pediatric Neurological Quality of Life (Neuro-QoL) | Follow-up Mean Pediatric Score for Fatigue | 45.97 T-score | Standard Deviation 8.14 |
Secondary
Picture Vocabulary Test
Data on cognitive function was collected using the Picture Vocabulary subtest from the NIH Toolbox. Single words are presented via an audio file, paired simultaneously with 4 screen images of objects, actions, and/or depictions of concepts. The task is to pick the picture that matches the spoken word. Performance on the task was transformed into a t-score from 0 to 100 where a higher t-score indicates better performance. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and after 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 10 did not complete this assessment due to a technical issue where the fully adjusted score was not calculated. Subject 9 was withdrawn from the study prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Picture Vocabulary Test | Baseline Mean of the Fully Adjusted Picture Vocabulary Score | 42.88 T-score | Standard Deviation 8.86 |
| Cannabidiol/ Epidiolex | Picture Vocabulary Test | Follow-up Mean of the Fully Adjusted Picture Vocabulary Score | 42.38 T-score | Standard Deviation 9.43 |
Secondary
Port-wine Birthmark Score
Data on facial port-wine birthmarks was collected using the Port-wine Birthmark Score. Data on percent of face covered, thickness of birthmark, and darkness of birthmark color was collected and transformed into a score from 0 to 43 where higher scores indicate greater severity and greater surface area involved. Data was collected at baseline and 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up appointment and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Port-wine Birthmark Score | Follow-up Mean Total Score | 8.11 score on a scale | Standard Deviation 3.18 |
| Cannabidiol/ Epidiolex | Port-wine Birthmark Score | Baseline Mean Total Score | 8.56 score on a scale | Standard Deviation 3.09 |
Secondary
Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55)
Data on quality of life was collected using the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55). Data on the frequency of an event (e.g. had trouble concentrating on a task) was collected and transformed into a score from 0 to 100 where higher scores reflect better quality of life. Data was collected at baseline and 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 7 misplaced this assessment and was not included in analysis. Subject 9 was withdrawn prior to the 6 month follow-up appointment due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) | Baseline Mean Total Score | 61.17 score on a scale | Standard Deviation 18.14 |
| Cannabidiol/ Epidiolex | Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) | Follow-up Mean Total Score | 71.39 score on a scale | Standard Deviation 10.75 |
Secondary
Safety of Epidiolex
Safety of Epidiolex was measured by the number of adverse events and serious adverse events that result from study drug.
Time frame: Baseline, Follow-up (6 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cannabidiol/ Epidiolex | Safety of Epidiolex | Number of Adverse Events that Resulted from the Study Drug | 24 Events |
| Cannabidiol/ Epidiolex | Safety of Epidiolex | Number of Serious Adverse Events that Resulted from the Study Drug | 0 Events |
Secondary
Screen for Child Anxiety Related Disorders (SCARED)
Data on anxiety was collected using the Screen for Child Anxiety Related Disorders (SCARED). Data on the truthfulness of a statement (e.g. I am nervous) was collected and transformed into a score from 0 to 82 where higher scores indicate greater anxiety. Data was collected at baseline and 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 7 misplaced this assessment and was not included in analysis. Subject 9 was withdrawn from the study prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Screen for Child Anxiety Related Disorders (SCARED) | Baseline Mean of Total Score | 14.86 score on a scale | Standard Deviation 14.49 |
| Cannabidiol/ Epidiolex | Screen for Child Anxiety Related Disorders (SCARED) | Follow-up Mean of Total Score | 11.57 score on a scale | Standard Deviation 11.16 |
Secondary
Seizure Frequency
Change in seizure frequency by seizure score at pre-treatment baseline and after six months. The seizure score is taken from the Sturge-Weber Neuroscore on a scale of 0 to 4 where 0=none, 1=1+. but controlled, 2=Breakthrough, 3=monthly, 4=Weekly+. Higher scores indicate worse outcome.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Seizure Frequency | Baseline Seizure Score from Sturge-Weber Neuroscore | 1.11 score on a scale | Standard Deviation 0.33 |
| Cannabidiol/ Epidiolex | Seizure Frequency | Follow-up Seizure Score from Sturge-Weber Neuroscore | 1.00 score on a scale | Standard Deviation 0 |
Secondary
Social Responsiveness Scale, Second Edition (SRS-2)
Data on social function was collected using the Social Responsiveness Scale-Second Edition (SRS-2). Data on a child's ability to engage in emotionally appropriate reciprocal social interactions in naturalistic settings was collected and transformed into a t-score from 0 to 100 where higher scores indicate greater impairment in social function. T-score of 50 indicates the population mean with a standard deviation of 10. Data was collected at baseline and 6 months on study drug.
Time frame: Baseline, Follow-up (6 months)
Population: Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Social Responsiveness Scale, Second Edition (SRS-2) | Baseline Mean Total Score | 54.22 T-score | Standard Deviation 7.71 |
| Cannabidiol/ Epidiolex | Social Responsiveness Scale, Second Edition (SRS-2) | Follow-up Mean Total Score | 49.22 T-score | Standard Deviation 7.09 |
Secondary
Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV)
Data on cognitive function was collected using selected subtests, from either the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale (WAIS-IV). For the WISC-V and WAIS-IV subtests selected, scaled scores were derived from the normative data which account for age and demographic information. The selected WISC-V/WAIS-IV subtests were as follows: Digit Span, Symbol Search, Coding and Processing Speed; the first three subtests were scored from 0-10, the fourth subtest from 0-100, and for all subtests higher score is better. The selected subtests, from the WISC-V and the WAIS-IV, were combined to increase statistical power. Statistically rare changes in individual test scores were determined using a reliable change index methodology based upon normative information for these assessments.
Time frame: Baseline, Follow-up (6 months)
Population: Subjects 1 and 10 did not complete this questionnaire as they were too young. Subject 9 was withdrawn prior to the 6 month follow-up visit due to a persistent side effect and was not included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Baseline Mean Digit Span Score | 5.71 score on a scale | Standard Deviation 2.81 |
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Follow-up Mean Digit Span Score | 6.43 score on a scale | Standard Deviation 2.07 |
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Baseline Mean Symbol Search Score | 6.00 score on a scale | Standard Deviation 2.71 |
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Follow-up Mean Symbol Search Score | 5.57 score on a scale | Standard Deviation 2.07 |
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Baseline Mean Coding Score | 5.57 score on a scale | Standard Deviation 2.88 |
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Follow-up Mean Coding Score | 4.71 score on a scale | Standard Deviation 2.22 |
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Baseline Mean Processing Speed Score | 77.14 score on a scale | Standard Deviation 13.93 |
| Cannabidiol/ Epidiolex | Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) | Follow-up Mean Processing Speed Score | 73.43 score on a scale | Standard Deviation 11.19 |