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CBDV vs Placebo in Children and Adults up to Age 30 With Prader-Willi Syndrome (PWS)

NCT03848481 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-07

Study results available
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Summary

This study aims to examine the feasibility and safety of cannabidivarin (CBDV) as a treatment for children and young adults with PWS.

Conditions

Interventions

DRUG

CBDV Compound

CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of Tetrahydrocannabinol (THC).

DRUG

Placebo

Placebo oral solution contains matching excipients.

Sponsors & Collaborators

  • Foundation for Prader-Willi Research

    collaborator OTHER

  • GW Pharmaceuticals Ltd

    collaborator INDUSTRY

  • Eric Hollander

    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
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03848481 on ClinicalTrials.gov