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

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radius Pharmaceuticals, Inc.

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, and other treatment including thyroid hormone, must be on the same medication and dose for at least 6 weeks prior to Screening

Exclusion Criteria:

• Known use of cannabis or cannabinoid containing products (including topical products) within 4 weeks prior to screening

• Use of prescription or over-the-counter weight loss agents or drugs known to affect appetite (including glucagon like peptide 1 receptor agonist) within 2 months prior to screening

• Implementation of new food or environmental restrictions within one month of screening

• Living in a group home setting 50% or more of the time

• Uncontrolled chronic conditions (diabetes, sleep apnea, etc.)