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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT05098509
• Date of registration: 22/09/2021
• Prospective Registration: Yes
• Primary sponsor: Radius Pharmaceuticals, Inc.
• Public title: A Phase 2/3 Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader-Willi Syndrome SCOUT-015
• Scientific 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
• Date of first enrolment: April 13, 2022
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT05098509
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Intervention(s)

Drug: RAD011

Drug: Placebo

Primary Outcome(s)

HQ-CT Questionnaire [Time Frame: Baseline through Week 34]

Secondary Outcome(s)

Clinician Global Impression of Change (CGI-C) in Hyperphagia (CGI-S) [Time Frame: Baseline through Week 34]

Clinician Global Impression of Severity (CGI-S) of Hyperphagia [Time Frame: Baseline through Week 34]

Effect of RAD011 on Irritabilty [Time Frame: Baseline through Week 34]

Secondary ID(s)

SCOUT-015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors