Clinical Trials Directory

Trials / Completed

CompletedNCT04451668

An Open Label Study of FT218 in Subjects With Narcolepsy

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
184 (actual)
Sponsor
Avadel · Industry
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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

Detailed description

This study will enroll subjects with narcolepsy, either NT1 or NT2, who completed the FT218 Phase 3 REST-ON study or eligible subjects with narcolepsy currently receiving a stable dose of twice nightly sodium oxybate IR or mixed salts oxybate (regardless of whether they participated in the REST-ON study), or subjects who are naïve to oxybate therapy (i.e., FT218, twice nightly sodium oxybate IR or mixed salts oxybate). Following a screening period, subjects who meet the entry criteria will be enrolled into the study. Subjects who completed the FT218 Phase 3 REST-ON study will initiate treatment with FT218 at 4.5 g and will follow a titration schedule up to the highest tolerate dose (up to 9 g), or the dose deemed effective by the investigator. Subjects previously maintained on twice nightly sodium oxybate IR will initiate FT218 treatment at a dose equivalent or closest to the total gram dose of twice-nightly sodium oxybate IR and then titrate up or down, in accord with safety and effectiveness as determined by the investigator.

Conditions

Interventions

TypeNameDescription
DRUGFT218once nightly sodium oxybate extended release

Timeline

Start date
2020-06-12
Primary completion
2023-12-22
Completion
2024-11-18
First posted
2020-06-30
Last updated
2025-10-02

Locations

29 sites across 2 countries: United States, Canada

Regulatory

Source: ClinicalTrials.gov record NCT04451668. Inclusion in this directory is not an endorsement.