Trials / Terminated
TerminatedNCT04252586
A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
An Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will be conducted to evaluate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in participants with Rett syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GWP42003-P | GWP42003-P presented as an oral solution containing cannabidiol in the excipients sesame oil with anhydrous ethanol, sweetener (sucralose), and strawberry flavoring |
Timeline
- Start date
- 2020-02-28
- Primary completion
- 2021-06-09
- Completion
- 2021-06-09
- First posted
- 2020-02-05
- Last updated
- 2022-08-08
- Results posted
- 2022-08-08
Locations
31 sites across 6 countries: United States, Australia, Canada, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04252586. Inclusion in this directory is not an endorsement.