NCT05098509

A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi Syndrome

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Radius Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 8 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011 in order to select 1 or 2 dose level(s) for further evaluation in the Phase 3 part of the study. In Phase 3, the primary objective was to assess the effect of RAD011 on hyperphagia-related behavior in participants with PWS.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	RAD011	Cannabidiol Oral Solution (containing synthetic cannabidiol)
DRUG	Placebo	Matching Placebo for RAD011

Timeline

• Start date: 2022-04-13
• Primary completion: 2022-10-06
• Completion: 2022-10-31
• First posted: 2021-10-28
• Last updated: 2023-10-19
• Results posted: 2023-10-19

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study