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RAD011 in Prader-Willi Syndrome
NCT05098509Phase 3
Key facts
- Status
- Terminated
- Start
- Apr 2022
- Primary completion
- Oct 2022
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- RAD011
- Conditions
- Prader-Willi syndrome (PWS)
01
Overview
Phase 3, randomised, double-blind trial of RAD011 in Prader-Willi syndrome (PWS) (4 arms). Primary endpoint: Hyperphagia Questionnaire for Clinical Trials at Week 34. Started Apr 2022; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
RAD011 40 mg/kg
RAD011 40 mg/kg orally daily
RAD011 20 mg/kg
RAD011 20 mg/kg orally daily
RAD011 10 mg/kg
RAD011 10 mg/kg orally daily
Placebo
Matching placebo orally daily
03
Who it enrols
Patients aged 8-65 with genetically confirmed Prader-Willi Syndrome, stable on existing medications for 90 days, and meeting specific hyperphagia score criteria during run-in.
04
Endpoints
Primary
Hyperphagia Questionnaire for Clinical Trials
Secondary
Aberrant Behavior Checklist - Irritability Subscale
Clinician Global Impression of Change
Clinician Global Impression of Severity
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