Back to resultsA Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome
Primary Purpose
Prader-Willi Syndrome
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
RAD011
Sponsored by
About this trial
This is an interventional treatment trial for Prader-Willi Syndrome
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RAD011
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05387798
First Posted
May 17, 2022
Last Updated
October 3, 2022
Sponsor
Radius Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05387798
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Program terminated
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radius Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prader-Willi Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RAD011
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RAD011
Intervention Description
Cannabidiol Oral Solution (containing synthetic cannabidiol)
Primary Outcome Measure Information:
Title
Assess the safety of RAD011 by evaluating the incidence and severity of adverse events reported
Description
Safety analyses will be conducted in all subjects who receive at least one dose of RAD011
Time Frame
Baseline through Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome
We'll reach out to this number within 24 hrs