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

Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Assess the safety of RAD011 by evaluating the incidence and severity of adverse events reported

Condition

Prader-Willi Syndrome

Intervention

RAD011

Study Arms / Comparison Groups

 RAD011

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

200

Start Date

January 2023

Completion Date

August 2025

Primary Completion Date

August 2025

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.
      

Gender

All

Ages

8 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 617-444-1800, [email protected]

NCT ID

NCT05387798

Organization ID

SCOUT-016

Responsible Party

Sponsor

Study Sponsor

Radius Pharmaceuticals, Inc.

Study Sponsor

, , 

Verification Date

May 2022