drugset / Trial / NCT05098509
A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2022-04-13
- Primary completion
- 2022-10-06
- Completion
- 2022-10-31
Outcome
Outcome not reported
Stopped: “Due to a change in corporate priorities, this study was voluntarily terminated by the Sponsor for reasons other than safety”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | RAD011 | Unknown | 10 mg/kg | Oral |
| Comparator | RAD011 | Unknown | 20 mg/kg | Oral |
| Comparator | RAD011 | Unknown | 40 mg/kg | Oral |