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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
184
once nightly sodium oxybate extended release
Incidence of treatment-related adverse events
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing treatment-related adverse events
Time frame: 24 months
Incidence of clinically significant changes in vital signs
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in vital signs
Time frame: 24 months
Incidence of clinically significant changes in laboratory test results
Assess the long-term safety and tolerability of FT218 by the number of participants experiencing clinically significant changes in laboratory test results
Time frame: 24 months
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Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Stanford Sleep Medicine
Redwood City, California, United States
SDS Clinical Trials
Santa Ana, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Delta Waves, Inc.
Colorado Springs, Colorado, United States
Pulmonary Disease Specialists, PA
Kissimmee, Florida, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
FL Pediatric Research Institute
Winter Park, Florida, United States
NeuroTrials Research Inc
Atlanta, Georgia, United States
SleepCare Research Institute, Inc. d/b/a Clinical Research Institute
Stockbridge, Georgia, United States
...and 19 more locations