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

NCT03202303 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-22

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Cannabidivarin

Weight-based dosing of 10 mg/kg/day of CBDV

DRUG

Matched Placebo

Weight-based dosing of 10 mg/kg/day of placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • GW Pharmaceuticals Ltd

    collaborator INDUSTRY

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Eric Hollander, MD · Montefiore Medical Center/Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-12
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03202303 on ClinicalTrials.gov