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NCT04451668 · ClinicalTrials.gov registry record · Phase 3
An Open Label Study of FT218 in Subjects With Narcolepsy
A Phase 3 study, sponsored by Avadel.
- Completed
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
NCT04451668: Completed Phase 3 study, sponsored by Avadel.
NCT04451668 is a Phase 3 study that has completed, run by Avadel. The registered enrollment target is 184 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04451668, a Phase 3 study, has completed, sponsored by Avadel.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
Study Summary
An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy
Primary Outcome
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
Interventions
- DRUG FT218
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2024-11-18 |
| Phase | Phase 3 |
What the finished NCT04451668 record still lists
NCT04451668 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which FT218 is the first listed.
NCT04451668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04451668 about?
NCT04451668 is a clinical study titled "An Open Label Study of FT218 in Subjects With Narcolepsy". An Open Label Study to Evaluate Long-Term Safety and Tolerability of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) and the ability to switch from twice-nightly immediate release sodium oxybate to once-nightly FT218 for the Treatment of Excessive Daytime Sl...
What is the current status of trial NCT04451668?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2020-06-12. Estimated completion is 2024-11-18.
What interventions are being tested in trial NCT04451668?
The interventions under investigation include: FT218 (DRUG).
Who is sponsoring clinical trial NCT04451668?
This trial is sponsored by Avadel, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04451668's enrollment target sits among peer trials
184 1418th of 2000 higher than 581 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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