The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
212
Maintenance of Wakefulness Test (MWT)
Change from Baseline for MWT, which is the mean latency across 5 naps, averaged over the test day
Time frame: Study Visit 8 at 14 weeks
Proportion of Patients That Were Very Much Improved or Much Improved on Clinical Global Impression of Improvement as Compared to Screening
The CGI is the clinician's global impression of improvement in daytime sleepiness. For the CGI, a GLIMMIX (generalized linear mixed models) model for binomial data with logit link was used to analyze the categorized CGI response, i.e., the proportions of subjects who were Very Much Improved or Much Improved as compared to Screening
Time frame: Study Visit 8 at 14 weeks
Number of Cataplexy Attacks at Visit 8 (Week 14) as Compared to Baseline
Mean number of cataplexy events recorded on the Sleep and Symptom Daily Diary during the period
Time frame: Visit 8 - Change from Baseline at 14 Weeks
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Pinnacle Research Group LLC
Anniston, Alabama, United States
University Sleep Disorder Center
Auburn, Alabama, United States
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
California Center for Sleep Disorders
Alameda, California, United States
Stanford Sleep Medicine
Redwood City, California, United States
SDS Clinical Trials Inc
Santa Ana, California, United States
Alpine Research Center
Boulder, Colorado, United States
Yale-New Haven Hospital's Sleep Medicine Center
North Haven, Connecticut, United States
Pulmonary Disease Specialist, PA
Kissimmee, Florida, United States
...and 47 more locations