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

NCT ID: NCT05387798

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2025-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RAD011

Group Type: EXPERIMENTAL

RAD011

Intervention Type: DRUG

Cannabidiol Oral Solution (containing synthetic cannabidiol)

Interventions

RAD011

Cannabidiol Oral Solution (containing synthetic cannabidiol)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radius Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SCOUT-016

Identifier Type: -

Identifier Source: org_study_id