Trials / Withdrawn
WithdrawnNCT04133480
Investigation of Cognitive Outcomes With Cannabidiol Oral Solution
An Open-Label Exploratory Investigation of Cognitive Outcomes With Cannabidiol Oral Solution (EPIDIOLEX®; GWP42003-P)
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 3 Years – 10 Years
- Healthy volunteers
- Not accepted
Summary
This study is being conducted to evaluate the effects of GWP42003-P on cognition in pediatric participants, aged 3 to 10 years, with Lennox-Gastaut Syndrome (LGS).
Detailed description
This trial is a 30-week (4-week baseline period; 26-week treatment period) open-label exploratory investigation of the effects of GWP42003-P on cognitive abilities in participants with LGS who reside in the United States.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GWP42003-P | oral solution of 100 milligrams per milliliter (mg/mL) cannabidiol (CBD) |
Timeline
- Start date
- 2020-10-01
- Primary completion
- 2021-12-01
- Completion
- 2021-12-01
- First posted
- 2019-10-21
- Last updated
- 2022-09-01
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04133480. Inclusion in this directory is not an endorsement.