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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 : June 26, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

Brief Summary:
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Cannabidivarin (CBDV) Drug: Matched Placebo Phase 2

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 : July 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT03202303


Contacts
Contact: Danya Schlussel, BA 718-920-6732 dschluss@montefiore.org
Contact: Bonnie P Taylor, PhD 718-920-2909 botaylor@montefiore.org

Sponsors and Collaborators
Eric Hollander
United States Department of Defense
Investigators
Principal Investigator: Eric Hollander, MD Montefiore Medical Center/Albert Einstein College of Medicine

Responsible Party: Eric Hollander, Prof, Psychiatry and Behavioral Sciences, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03202303     History of Changes
Other Study ID Numbers: 2017-8538
AR160104 ( Other Grant/Funding Number: Department of Defense )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eric Hollander, Montefiore Medical Center:
Autism
Irritability
cannabinoids

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders