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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Prader-Willi Syndrome

In brief

This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011 in order to select 1 or 2 dose level(s) for further evaluation in the Phase 3 part of the study. In Phase 3, the primary objective was to assess the effect of RAD011 on hyperphagia-related behavior in participants with PWS.

Key facts

Study ID

NCT05098509

Run by

Radius Pharmaceuticals, Inc.

People needed

4

Starts

2022-04-13

Expected to finish

2022-10-31

Last updated by the study team

2023-10-19

Who can join

Age: 8 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, participants will have a mean Hyperphagia Questionnaire for Clinical Trials (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

You may not qualify if…

• 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, participant spends less than 25 waking hours with their caregiver per week.
• Uncontrolled chronic conditions (diabetes, sleep apnea, etc.) as determined by the Investigator.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Rady Children's Hospital — San Diego, California, United States
• University of Iowa — Iowa City, Iowa, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Research Institute of Dallas — Dallas, Texas, United States
• MultiCare Institute for Research & Innovation — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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