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Trial record 2 of 3 for:    cannabinoids | autism

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

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ClinicalTrials.gov Identifier: NCT03202303
Recruitment Status : Not yet recruiting
First Posted : June 28, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

June 27, 2017
June 28, 2017
November 14, 2018
December 2018
June 30, 2021   (Final data collection date for primary outcome measure)
Aberrant Behavior Checklist-Irritability Subscale (ABC-I) [ Time Frame: Change in ABC-I from Baseline to Week 12 (Change over 12 weeks) ]
Change in ABC-I from Baseline to Endpoint
Same as current
Complete list of historical versions of study NCT03202303 on ClinicalTrials.gov Archive Site
  • Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: Change in RBS-R from Baseline to Week 12 (Change over 12 weeks) ]
    Change in RBS-R from Baseline to Endpoint
  • Aberrant Behavior Checklist-Social Withdrawal Subscale (ABC-SW) [ Time Frame: Change in ABC-SW from Baseline to Week 12 (Change over 12 weeks) ]
    Change in ABC-SW from Baseline to Endpoint
  • Pediatric Quality of Life Inventory (PedsQL) Family Impact Module [ Time Frame: Change in PedsQL from Baseline to Week 12 (Change over 12 weeks) ]
    Change in PedsQL from Baseline to Endpoint
  • Vineland Adaptive Behavior Scale-II (VABS-II) [ Time Frame: Change in VABS-II from Baseline to Week 12 (Change over 12 weeks) ]
    Change in VABS-II from Baseline to Endpoint
  • Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Change in CGI-I from Baseline to Week 12 (Change over 12 weeks) ]
    Change in CGI-I from Baseline to Endpoint
Same as current
Not Provided
Not Provided
 
Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
Not Provided
Interventional
Phase 2
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
Autism Spectrum Disorder
  • Drug: Cannabidivarin (CBDV)
    Weight-based dosing of 10 mg/kg/day of CBDV
  • Drug: Matched Placebo
    Weight-based dosing of 10 mg/kg/day of placebo
  • Experimental: Cannabidivarin (CBDV)
    Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks
    Intervention: Drug: Cannabidivarin (CBDV)
  • Placebo Comparator: Matched Placebo
    Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks
    Intervention: Drug: Matched Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Same as current
September 30, 2021
June 30, 2021   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 18 Years   (Child, Adult)
No
Contact: Danya Schlussel, BA 718-920-6732 dschluss@montefiore.org
Contact: Bonnie P Taylor, PhD 718-920-2909 botaylor@montefiore.org
Not Provided
 
 
NCT03202303
2017-8538
AR160104 ( Other Grant/Funding Number: Department of Defense )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Eric Hollander, Montefiore Medical Center
Eric Hollander
United States Department of Defense
Principal Investigator: Eric Hollander, MD Montefiore Medical Center/Albert Einstein College of Medicine
Montefiore Medical Center
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP