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A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi Syndrome (SCOUT-015)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05098509
Recruitment Status : Recruiting
First Posted : October 28, 2021
Last Update Posted : May 19, 2022
Sponsor:
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

Brief Summary:
This is a seamless Phase 2/3, double-blind, randomized, placebo-controlled clinical study in patients diagnosed with PWS. Following consent (or legal guardian consent and patient assent as appropriate), patients will be screened for eligibility to participate in this study.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: RAD011 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi Syndrome
Actual Study Start Date : April 13, 2022
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Active Comparator: RAD011 high dose Drug: RAD011
Cannabidiol Oral Solution (containing synthetic cannabidiol)

Active Comparator: RAD011 medium dose Drug: RAD011
Cannabidiol Oral Solution (containing synthetic cannabidiol)

Active Comparator: RAD011 low dose Drug: RAD011
Cannabidiol Oral Solution (containing synthetic cannabidiol)

Placebo Comparator: Placebo Drug: Placebo
Matching Placebo for RAD011




Primary Outcome Measures :
  1. HQ-CT Questionnaire [ Time Frame: Baseline through Week 34 ]
    The primary objective of the Phase 3 part of this study is to assess the change in HQCT score from Baseline to End of Study (Week 34) for RAD011 compared to placebo. This is a fully validated 9 question scale, with scores from 0 to 36, where the higher the score, the worse the condition.


Secondary Outcome Measures :
  1. Effect of RAD011 on Irritabilty [ Time Frame: Baseline through Week 34 ]
    Change in PWS-associated Irritability from Baseline through End of Study/Week 34 Visit using the Aberrant Behavior Checklist (ABC) questionnaire - Irritability subscale (ABC-I) for RAD011 compared to placebo

  2. Clinician Global Impression of Change (CGI-C) in Hyperphagia (CGI-S) [ Time Frame: Baseline through Week 34 ]
    Change in hyperphagia as defined by the Clinician Global Impression of Change (CGI-C) in Hyperphagia. The answers range from Much Better to Much Worse.

  3. Clinician Global Impression of Severity (CGI-S) of Hyperphagia [ Time Frame: Baseline through Week 34 ]
    Change in Clinician Global Impression of Severity (CGI-S) of Hyperphagia. The answers range from Much Better to Much Worse.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between 8 and 65 years of age (inclusive) at Screening
  • Genetically confirmed diagnosis of PWS. Documentation of genetically confirmed diagnosis of PWS is acceptable.
  • The same caregiver is available to complete the questionnaire throughout the duration of the study.
  • After completion of the Tolerability period, Patients will have a mean HQ-CT score >= 13 and a decrease of HQ-CT score no more than 7 during Tolerability (run-in) period
  • If receiving growth hormone, psychotropic therapy, metabolic treatments that could affect appetite (including metformin), and other treatment including thyroid hormone, must be on the same medication and dose for at least 90 days prior to consent/assent

Exclusion Criteria:

  • Known use of cannabis or cannabinoid containing products (including topical products) within 90 days prior to consent/ assent
  • Use of prescription or over-the-counter weight loss agents within 90 days prior to consent/assent
  • Implementation of new food or environmental restrictions within 90 days of consent/ assent
  • If living in a group home, patient spends less than 25 waking hours with their caregiver per week
  • Uncontrolled chronic conditions (diabetes, sleep apnea, etc.) as determined by the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05098509


Contacts
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Contact: Ellie Ratigan 617-444-1800 scout015@radiuspharm.com
Contact: Nick Poulson 617-444-1800 scout015@radiuspharm.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Radius Pharmaceuticals, Inc.
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Responsible Party: Radius Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05098509    
Other Study ID Numbers: SCOUT-015
First Posted: October 28, 2021    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders