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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 is a Phase 3 study that has completed, run by Avadel. The registered enrollment target is 184 participants.
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
Interventions
- DRUG FT218
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2020-06-12 |
| Est. Completion | 2024-11-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04451668
The ClinicalTrials.gov registry entry for NCT04451668 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Avadel, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FT218 is the first listed.
NCT04451668 reports 0 study locations.
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.
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