Trials / Completed
CompletedNCT02954887
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
A Randomized, Double-blind, Placebo-controlled Trial to Investigate the Efficacy and Safety of Cannabidiol (CBD; GWP42003-P) in Infants With Infantile Spasms Following an Initial Open-label Pilot Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Month – 24 Months
- Healthy volunteers
- Not accepted
Summary
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive GWP42003-P.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GWP42003-P | Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. |
Timeline
- Start date
- 2017-05-12
- Primary completion
- 2019-06-13
- Completion
- 2019-06-13
- First posted
- 2016-11-04
- Last updated
- 2022-09-02
- Results posted
- 2020-07-23
Locations
7 sites across 2 countries: United States, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02954887. Inclusion in this directory is not an endorsement.