Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
ClinicalTrials.gov Identifier : NCT03202303
Recruitment Status : Not yet recruiting
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase 2, 12-week double-blind, randomized, placebo-controlled trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
|Experimental: Cannabidivarin (CBDV)
Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks
|Drug: Cannabidivarin (CBDV)
Weight-based dosing of 10 mg/kg/day of CBDV
|Placebo Comparator: Matched Placebo
Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks
|Drug: Matched Placebo
Weight-based dosing of 10 mg/kg/day of placebo
|Ages Eligible for Study:||5 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Male or Female pediatric outpatients aged 5 to 18 years old
- Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria
- Aberrant Behavior Checklist (ABC) – Irritability Subscale score of 18 or greater at screening visit
- Social Responsiveness Scale (SRS) score of 66T or higher at screening visit
- Clinical Global Impression Scale – Severity (CGI-S) score of 4 or higher at screening
- Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to randomization and for the duration of the study.
- Physical exam and laboratory results that are within normal range for individuals with ASD
- Presence of a parent/caregiver/guardian that is able to consent for their participation and complete assessments regarding the child’s development and behavior throughout the study
- Exposure to any investigational agent in the 30 days prior to randomization.
- Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment.
- Positive testing for THC or other drugs of abuse at the screening or baseline visits upon repeat confirmation testing.
- Lifetime history of drug abuse including marijuana/cannabis use
- Diagnosis of a known genetic disorder (ie. Prader-Willi Syndrome, Angelman Syndrome etc.)
- A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, PTSD or MDD. These patients will be excluded due to potential confounding results.
- Pregnant or lactating patients or patients who will not agree to be abstinent or use a double barrier method of contraception. CBDV has not been studied in pregnant or lactating women.
- A medical condition that severely impacts the subject’s ability to participate in the study, interferes with the conduct of the study, confounds interpretation of study results or endangers the subject’s well-being.
- A known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or marked sensory impairment such as deafness or blindness.
- Subjects who have had changes in allied health therapies, behavioral or educational interventions within four weeks prior to randomization other than those associated with school holidays.
- Subjects who have had changes in medications or medication doses within four weeks of randomization.