A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome

A Phase 3, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome

This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015.

The primary objective of this study is to assess the long-term safety and tolerability of RAD011.

Study Overview

• Status: Withdrawn
• Conditions: Prader-Willi Syndrome
• Intervention / Treatment: Drug: RAD011

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of a parent/legal guardian that is able to consent for their participation. Parent/caregiver/legal guardian can complete the required assessments throughout the study. Patient Consent/Assent will be obtained if the patient is 8 years of age or older and has the mental capacity to understand and sign a written consent/assent form and/or give verbal assent;
• Patient completed treatment on the SCOUT-015 study through Visit 14 (Week 34);
• If female, is either not of childbearing potential (defined as premenarchal or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing one of the following medically acceptable methods of birth control up to 4 weeks after the last dose of

RAD011 or placebo:

Exclusion Criteria:

• Significant acute condition (active infection, uncontrolled diabetes, any other uncontrolled chronic condition) including but not limited to clinically significant laboratory abnormality, or medical or psychosocial condition that may preclude the patient from participating in the study, at the Investigator's discretion;
• Positive urine test for drugs of abuse, including tetrahydrocannabinol (THC), or known history of drug, alcohol, or substance abuse;
• Significant risk of committing suicide based on history, psychiatric examination, or based on the Investigator's judgment;
• Significant non-compliance issues (IP misuse or abuse, study visit participation, etc.) during the patient's SCOUT-015 participation based on the Investigator's judgement.
• Pregnant (determined by a positive urine pregnancy test) or lactating female;
• Concurrent participation in any other interventional study involving an investigational product, gene therapy, or device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RAD011	Drug: RAD011; Cannabidiol Oral Solution (containing synthetic cannabidiol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the safety of RAD011 by evaluating the incidence and severity of adverse events reported	Safety analyses will be conducted in all subjects who receive at least one dose of RAD011	Baseline through Week 52

Collaborators and Investigators

• Sponsor: Radius Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2023
• Primary Completion (ANTICIPATED): August 1, 2025
• Study Completion (ANTICIPATED): August 1, 2025

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (ACTUAL): May 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Overnutrition; Nutrition Disorders; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Obesity; Syndrome; Prader-Willi Syndrome
• Other Study ID Numbers: SCOUT-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No