Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
ClinicalTrials.gov Identifier : NCT03202303
Recruitment Status : Not yet recruiting
First Posted : June 28, 2017
Last Update Posted : April 2, 2019
https://clinicaltrials.gov/ct2/show/NCT03202303?term=cannabinoids&cond=Autism+Spectrum+Disorder&rank=2
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 |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
https://clinicaltrials.gov/ct2/show/NCT03202303