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 Information
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]
Administrative Informations
NCT ID
NCT05387798
Organization ID
SCOUT-016
Responsible Party
Sponsor
Study Sponsor
Radius Pharmaceuticals, Inc.
Study Sponsor
, ,
Verification Date
May 2022