Safety and Tolerability of Cannabidivarin (CBDV) in Children and Young Adults With Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT03849456|
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder||Drug: GWP42006||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Tolerability of GWP42006 in Children and Young Adults With Autism Spectrum Disorder|
|Actual Study Start Date :||January 7, 2020|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||November 2021|
Oral solution taken twice daily with food for 52 weeks.
Oral solution containing cannabidivarin 50 milligrams per milliliter (mg/mL) in sesame oil with anhydrous ethanol, sucralose, strawberry flavoring, and β-carotene.
- Number of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to Day 403 ]A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of GWP42006. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of GWP42006, then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through to the Safety Follow-up will be presented.
- Change from Baseline in Children's Communication Checklist-2 (CCC-2) [ Time Frame: Baseline to End of Treatment (Day 365) or Early Termination (ET) ]The CCC-2 is a caregiver-completed measure designed to assess the communication skills of children 4 to 16 years of age. An increase in score indicates an improvement.
- Change from Baseline in Social Responsiveness Scale-2 (SRS-2) [ Time Frame: Baseline to End of Treatment (Day 365) or ET ]The SRS-2 assesses social impairment associated with Autism Spectrum Disorder (ASD). Total scores between 58 and 72 indicate a mild deficiency, between 73 and 97 indicate a moderate deficiency, and 98 or above indicate a severe deficiency. A decrease in total score indicates an improvement.
- Change from Baseline in Vineland Adaptive Behavior Scales, 3rd Edition (Vineland-3) [ Time Frame: Baseline to End of Treatment (Day 365) or ET ]The Vineland-3 measures the personal and social skills of individuals from birth through adulthood. Score ranges are as follows: 70 to 80, borderline adaptive functioning; 51 to 70, mildly deficient adaptive functioning; 35 to 50, moderately deficient adaptive behavior; 20 to 35, severely deficient adaptive behavior; less than 20, markedly or profoundly deficient adaptive behavior.
- Change from Baseline in National Institutes of Health (NIH) Toolbox Cognition Battery [ Time Frame: Baseline to End of Treatment (Day 365) or ET ]The NIH Toolbox Cognition Battery has computerized instruments that measure several ability subdomains important for cognitive health.
- Change from Baseline in Repetitive Behavioral Scale - Revised (RBS-R) [ Time Frame: Baseline to End of Treatment (Day 365) or ET ]The RBS-R is used to measure the breadth of repetitive behavior in children, adolescents, and adults with ASD. Total scores range from 0 to 129. A decrease in total score indicates an improvement.
- Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) [ Time Frame: Baseline to End of Treatment (Day 365) or ET ]The CSHQ is used to examine sleep behavior in young children. Responses are given on a 5-point scale (1 = always; 5 = never). A higher score reflects more sleep problems.
- Change from Baseline in Aberrant Behavior Checklist (ABC) [ Time Frame: Baseline to End of Treatment (Day 365) or ET ]The ABC assesses the presence and severity of various problem behaviors commonly observed in individuals diagnosed with intellectual and developmental disabilities. Total scores range from 0 to 174. A decrease in total score indicates an improvement.
- Clinical Global Impressions-Improvement (CGI-Improvement) [ Time Frame: Baseline to End of Treatment (Day 365) or ET ]The CGI-Improvement evaluates the change from the initiation of treatment in the severity of psychopathology using a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Lower scores represent an improvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849456
|Contact: Medical Enquiries||(833)email@example.com, firstname.lastname@example.org|
|United States, Kentucky|
|Clinical Trial Site||Recruiting|
|Louisville, Kentucky, United States, 40202|
|United States, Massachusetts|
|Clinical Trial Site||Not yet recruiting|
|Lexington, Massachusetts, United States, 02421|
|United States, Ohio|
|Clinical Trial Site||Not yet recruiting|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Gregory N Barnes, MD PhD||University of Louisville|