← Back to Search

RAD011 20 mg/kg for Prader-Willi Syndrome (SCOUT-015 Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Radius Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 38

Awards & highlights

SCOUT-015 Trial Summary

This trial is testing a new drug for people with Prader-Willi Syndrome. If you qualify and participate, you may be randomly assigned to receive either the drug or a placebo.

Eligible Conditions

Prader-Willi Syndrome

SCOUT-015 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 38

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 38

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 38 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline to Week 34 in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Questionnaire

Secondary outcome measures

Change From Baseline to Week 34 in Hyperphagia as Measured by the Clinician Global Impression of Change (CGI-C)

Change From Baseline to Week 34 in Hyperphagia as Measured by the Clinician Global Impression of Severity (CGI-S)

Change From Baseline to Week 34 in Prader-Willi Syndrome (PWS)- Associated Irritability Using the Aberrant Behavior Checklist (ABC) Questionnaire - Irritability Subscale (ABC-I)

Other outcome measures

Safety

SCOUT-015 Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: RAD011 20 mg/kgActive Control1 Intervention

Participants were administered 20 mg/kg of RAD011 orally daily with food.

Group II: RAD011 10 mg/kgActive Control1 Intervention

Participants were administered 10 mg/kg of RAD011 orally daily with food.

Group III: RAD011 40 milligrams per kilogram (mg/kg)Active Control1 Intervention

Participants were administered 40 mg/kg of RAD011 orally daily with food.

Group IV: PlaceboPlacebo Group1 Intervention

Participants were administered a placebo matching to RAD011, orally daily with food.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Radius Pharmaceuticals, Inc.Lead Sponsor

12 Previous Clinical Trials

852 Total Patients Enrolled

3 Trials studying Prader-Willi Syndrome

9 Patients Enrolled for Prader-Willi Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be a participant in this clinical research?

"Given that royer syndrome is a rare genetic disorder, the trial designers have set 220 as the maximum number of patients they will accept. To qualify, participants must currently suffer from royer syndrome and be between 8 and 65 years old."

Answered by AI

Are we still looking for more individuals to participate in this research?

"The clinical trial mentioned is not recruiting patients at this time. The study was initially posted on 4/13/2022 and was last edited on 10/3/2022. Although this particular study isn't looking for candidates, there are 1451 other trials that are presently enrolling participants."

Answered by AI

Is the age limit for this clinical trial set at 80 years or below?

"Children as young as 8 and adults up to the age of 65 may be eligible for this clinical trial. There are 388 other studies available for patients younger than 18 and 1033 trials for patients that are elderly."

Answered by AI

Is this study accessible to patients in urban areas?

"Currently, this trial has 17 different medical centres recruiting patients which include Rady Children's Hospital in San Diego, Nationwide Children's Hospital in Columbus and Maimonides Medical Center in Brooklyn."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome

2022. "A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05098509.