Trials / Completed
CompletedNCT02720744
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 212 (actual)
- Sponsor
- Avadel · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FT218 | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-11-17
- Primary completion
- 2020-03-25
- Completion
- 2020-03-25
- First posted
- 2016-03-28
- Last updated
- 2022-03-22
- Results posted
- 2022-03-22
Locations
57 sites across 6 countries: United States, Australia, Canada, Czechia, France, Germany
Source: ClinicalTrials.gov record NCT02720744. Inclusion in this directory is not an endorsement.