NCT03848481

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This clinical research trial aims to study the feasibility and safety of cannabidivarin (CBDV), in children and young adults with Prader-Willi Syndrome (PWS). CBDV has effects independent of CB1 and CB2 receptor activation and a good safety profile. This proposal addresses the Foundation for Prader Willi Research's PWS Research Plan: Program 1, Clinical Care Research: seeks to evaluate treatments that aim to reduce behavioral symptoms, such as irritability, in order to improve the quality of life of both the individual with PWS and their families. GW Pharmaceuticals will provide the CBDV drug and matching placebo.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	CBDV Compound	CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of THC
DRUG	Placebo	Placebo oral solution contains matching excipients.

Timeline

• Start date: 2020-11-23
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2019-02-20
• Last updated: 2024-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study