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

NCT05387798 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: SCOUT-016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prader-Willi Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

RAD011

EXPERIMENTAL

Drug: RAD011

Interventions

RAD011 DRUG

Cannabidiol Oral Solution (containing synthetic cannabidiol)

RAD011

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radius Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Prader-Willi Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: January 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 6, 2022

Record last verified: 2022-10