NCT02844933

Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution for the Treatment of Patients With Prader-Willi Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Radius Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of cannabidiol oral solution on hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS). The secondary objectives of this study are to assess the efficacy, safety and tolerability, impact on quality of life, and impact on physical activity of cannabidiol oral solution in patients with PWS.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Cannabidiol	Oral solution
DRUG	Placebo	Matching oral solution

Timeline

• Start date: 2018-05-09
• Primary completion: 2019-07-17
• Completion: 2019-07-31
• First posted: 2016-07-26
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study