This study will be conducted to evaluate the efficacy of GWP42003-P, compared with placebo, in reducing symptom severity in children with Autism Spectrum Disorder (ASD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
GWP42003-P oral solution (100 milligrams per milliliter \[mg/mL\] cannabidiol \[CBD\] in sesame oil with anhydrous ethanol, ethanol \[10% v/v\] sweetener \[sucralose\], and strawberry flavoring), administered twice a day (morning and evening)
Oral placebo to match GWP42003-P oral solution containing sesame oil with anhydrous ethanol, sweetener (sucralose), strawberry flavoring, and beta carotene, administered twice a day (morning and evening)
Southwest Autism Research and Resource Center (SARRRC)
Phoenix, Arizona, United States
Change From Baseline in Aberrant Behavior Checklist (ABC) Subscale Total Scores
The caregiver-assessed ABC was designed to assess the presence and severity of various problem behaviors commonly observed in individuals diagnosed with intellectual and developmental disability. The checklist contains 5 subscales: Irritability (15 items); Social Withdrawal (16 items); Stereotypic Behavior (7 items); Hyperactivity/Noncompliance (16 items); and Inappropriate Speech (4 items). Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). The total score of all items for each subscale range from 0-45 (irritability), 0-48 (social withdrawal and hyperactivity/noncompliance), 0-21 (stereotypic behavior), and 0-12 (inappropriate speech) where higher scores indicate worse clinical outcome. The change from baseline to Week 4, Week 8, and Week 12 is reported with lower scores indicating better clinical outcome.
Time frame: Baseline up to Week 12
Change From Baseline in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores
The VABS-3 scales assess what a person does, rather than what he or she can do. The Vineland-3 assesses adaptive behavior in 3 domains: Communication, Daily Living Skills, and Socialization. Each domain is comprised of 3 subdomains: receptive expression and written (communication); personal, domestic and community (daily living skills); Interpersonal relationships, play and leisure and copying skills (socialization). The adaptive behavior composite score is calculated as arithmetic mean of all 3 domain scores. The total score range is 20 to 140, where low scores indicate low (worst) clinical outcome and high scores indicate high (best) clinical outcome. The change from baseline in VABS-3 is being reported with positive values indicating a positive improvement in adaptive behavior.
Time frame: Baseline up to Week 12
Number of Patients Per Clinical Global Impression Improvement (CGI-I) Category
The CGI-I is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. The clinician is asked: Compared to the patient's condition at admission to the project, how much has the patient changed? This is rated as: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Higher scores indicate worse clinical outcome. The number of patients in each CGI-I category is reported.
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UCSD School of Medicine
La Jolla, California, United States
UCLA Neuropsychiatric Institute
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
APG Research, LLC
Orlando, Florida, United States
University of Louisville
Louisville, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital (Lurie Center for Autism)
Lexington, Massachusetts, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
...and 13 more locations
Time frame: Day 85
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's experience with patients who have the same diagnosis. The clinician is asked: Considering your total clinical experience with this particular population, how ill is the patient at this time? This is rated as: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Higher scores indicate worse outcome. The change from baseline in CGI-S scores is reported and lower mean scores indicate better outcome.
Time frame: Baseline up to Week 12
Number of Participants Reporting Treatment-emergent Adverse Events
A TEAE is one that started, or worsened in severity or seriousness, following the first dose of IMP. AEs were coded according to the Medical Dictionary for Regulatory Activities v24.0 dictionary.
Time frame: Baseline up to Week 12
Mean Change From Baseline in Hematology Clinical Laboratory Levels
Time frame: Baseline up to Week 9 (end of taper/withdrawal)
Mean Percentage Change From Baseline in Hematology Clinical Laboratory Levels
Time frame: Baseline up to Week 9 (end of taper/withdrawal)
Mean Change From Baseline in Hemoglobin Levels
Time frame: Week 9 (end of taper/withdrawal)
Mean Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Levels
Time frame: Week 9 (end of taper/withdrawal)
Mean Change From Baseline in Erythrocyte Mean Corpuscular Volume Levels
Time frame: Week 9 (end of taper/withdrawal)
Number of Patients With Clinically Significant Vital Sign Values
Time frame: Post-baseline up to 12 weeks
Number of Patients With Clinically Significant Physical Examination Procedure Findings
Number of patients with abnormal physical exam findings are reported.
Time frame: Baseline up to Day 85 post-baseline
Number of Patients With Clinically Significant 12-lead Electrocardiogram Findings
Time frame: Baseline up to Day 85 post-baseline
Number of Participants Reporting Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS rating scale results since last visit is reported. The presence/absence of any suicidal ideation or behavior is scored based on yes/no responses. The overall number of participants reporting suicidal ideation or behavior is being reported.
Time frame: Baseline up to Day 92