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

Part of paid clinical trials in New York, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT03202303
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Cannabidivarin — DRUG
    Weight-based dosing of 10 mg/kg/day of CBDV
  • Matched Placebo — DRUG
    Weight-based dosing of 10 mg/kg/day of placebo

Study Details

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

Key Dates

Start date
Apr 12, 2019
Status verified
Oct 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cannabidivarin (CBDV)
    Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks
  • Placebo Comparator: Matched Placebo
    Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks

Primary Outcome Measure

Aberrant Behavior Checklist-Irritability (ABC-I) Subscale [ Time Frame: Change from Baseline to Week 12 (Change over 12 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New York University (NYU) LangoneNew YorkNew York10016-
Montefiore Medical CenterThe BronxNew York10467
Casara Ferretti
[email protected]
914-315-4236

Find similar trials in New York, NY

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
New York University (NYU) Langone· New York, NYMontefiore Medical Center· The Bronx, NY

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