An Open Label Study of FT218 in Subjects With Narcolepsy
Public ClinicalTrials.gov record NCT04451668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open Label Study of Safety/Tolerability of Once Nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy Patients That Have and Have Not Been Previously Maintained on Twice-nightly Sodium Oxybate IR
Study identification
- NCT ID
- NCT04451668
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Avadel
- Industry
- Enrollment
- 184 participants
Conditions and interventions
Conditions
Interventions
- FT218 Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2020
- Primary completion
- Dec 21, 2023
- Completion
- Nov 17, 2024
- Last update posted
- Oct 1, 2025
2020 – 2024
United States locations
- U.S. sites
- 27
- U.S. states
- 16
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | — |
| Stanford Sleep Medicine | Redwood City | California | 94063 | — |
| SDS Clinical Trials | Santa Ana | California | 92705 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Delta Waves, Inc. | Colorado Springs | Colorado | 80918 | — |
| Pulmonary Disease Specialists, PA | Kissimmee | Florida | 34741 | — |
| Sleep Medicine Specialists of South Florida | Miami | Florida | 33176 | — |
| FL Pediatric Research Institute | Winter Park | Florida | 32789 | — |
| NeuroTrials Research Inc | Atlanta | Georgia | 30328 | — |
| SleepCare Research Institute, Inc. d/b/a Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| Fort Wayne Neurological | Fort Wayne | Indiana | 46804 | — |
| Helene A. Emsellem, MD PC | Chevy Chase | Maryland | 20815 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| St. Luke's Hospital - Sleep Medicine and Research Center | Chesterfield | Missouri | 63017 | — |
| Montefiore Sleep-Wake Disorders Center | The Bronx | New York | 10467 | — |
| Advanced Respiratory and Sleep Medicine | Huntersville | North Carolina | 28078 | — |
| Sleep Management Institute Intrepid Research | Cincinnati | Ohio | 45245 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Brian Abaluck Sleep Medicine | Malvern | Pennsylvania | 19355 | — |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | — |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | — |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229-4849 | — |
| Comprehensive Sleep Medicine Associates | Sugar Land | Texas | 77478 | — |
| Northwest Houston Neurology | Tomball | Texas | 77375 | — |
| TPMG Clinical Research Williamsburg | Williamsburg | Virginia | 23188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04451668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2025 · Synced May 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04451668 live on ClinicalTrials.gov.