Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD), Identifier: NCT03202303, 2019

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD) Identifier : NCT03202303

Recruitment Status : Not yet recruiting

First Posted : June 28, 2017
Last Update Posted : April 2, 2019

Sponsor : Eric Hollander
Collaborators : United States Department of Defense, GW Pharmaceuticals
Information provided by (Responsible Party) : Eric Hollander, Montefiore Medical Center, USA
Study Design
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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)
Masking Description: Double-Blind
Primary Purpose: Treatment
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
Arms and Interventions
Arm Intervention/treatment
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

Inclusion Criteria:

  1. Male or Female pediatric outpatients aged 5 to 18 years old
  2. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria
  3. Aberrant Behavior Checklist (ABC) – Irritability Subscale score of 18 or greater at screening visit
  4. Social Responsiveness Scale (SRS) score of 66T or higher at screening visit
  5. Clinical Global Impression Scale – Severity (CGI-S) score of 4 or higher at screening
  6. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to randomization and for the duration of the study.
  7. Physical exam and laboratory results that are within normal range for individuals with ASD
  8. 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

Exclusion Criteria:

  1. Exposure to any investigational agent in the 30 days prior to randomization.
  2. Prior chronic treatment with CBD, CBDV or an endocannabinoid treatment.
  3. Positive testing for THC or other drugs of abuse at the screening or baseline visits upon repeat confirmation testing.
  4. Lifetime history of drug abuse including marijuana/cannabis use
  5. Diagnosis of a known genetic disorder (ie. Prader-Willi Syndrome, Angelman Syndrome etc.)
  6. 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.
  7. 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.
  8. 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.
  9. A known diagnosis of Rett Syndrome or Childhood Disintegrative Disorder, or marked sensory impairment such as deafness or blindness.
  10. 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.
  11. Subjects who have had changes in medications or medication doses within four weeks of randomization.