Trials / Withdrawn
WithdrawnNCT05387798
A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome
A Phase 3, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Radius Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 8 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015. The primary objective of this study is to assess the long-term safety and tolerability of RAD011.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RAD011 | Cannabidiol Oral Solution (containing synthetic cannabidiol) |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2025-08-01
- Completion
- 2025-08-01
- First posted
- 2022-05-24
- Last updated
- 2022-10-06
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05387798. Inclusion in this directory is not an endorsement.