NCT05098509

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

Terminated Phase 2, PHASE3 Results posted Last updated 19 October 2023

What this trial tests

Phase 2, PHASE3 trial testing RAD011 in Prader-Willi Syndrome in 4 participants. Terminated before completion.

Timeline

13 April 2022

Primary endpoint
6 October 2022

31 October 2022

Quick facts

Lead sponsor	Radius Pharmaceuticals, Inc.
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	4
Start date	13 April 2022
Primary completion	6 October 2022
Estimated completion	31 October 2022
Sites	8 locations across United States

Drugs / interventions tested

• RAD011 — full drug profile →
• Placebo

Conditions studied

• Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →

Sponsor

Radius Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 8 to 65, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 (after dosing) up to 68 days (maximum duration from treatment to early termination). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RAD011 10 mg/kg

Serious: 0/1 (0%)

Deaths: 0/1

RAD011 20 mg/kg

Serious: 0/1 (0%)

Deaths: 0/1

RAD011 40 mg/kg

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (7 terms — click to expand)

Reaction	System	RAD011 10 mg/kg	RAD011 20 mg/kg	RAD011 40 mg/kg
Diarrhea	Gastrointestinal disorders	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—
Lethargy	Nervous system disorders	—	—	—
Irritability	Psychiatric disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Fatigue	General disorders	—	—	—
Ear discomfort	Ear and labyrinth disorders	—	—	—

Data from ClinicalTrials.gov NCT05098509 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacotherapy of obesity: an update on the available medications and drugs under investigation.
   Chakhtoura M, Haber R, Ghezzawi M, Rhayem C, et al · · 2023 · cited 260× · PMID 36992862 · DOI 10.1016/j.eclinm.2023.101882
2. Prader-Willi and Angelman Syndromes: Mechanisms and Management.
   Ma VK, Mao R, Toth JN, Fulmer ML, et al · · 2023 · cited 15× · PMID 37051256 · DOI 10.2147/tacg.s372708
3. Medicinal Cannabis for Paediatric Developmental, Behavioural and Mental Health Disorders.
   Efron D, Taylor K. · · 2023 · cited 13× · PMID 37107712 · DOI 10.3390/ijerph20085430
4. Promising therapeutic aspects in human genetic imprinting disorders.
   Chao Y, Qin Y, Zou X, Wang X, et al · · 2022 · cited 6× · PMID 36371218 · DOI 10.1186/s13148-022-01369-6