Do you have Narcolepsy? Interested in participating in a clinical trial?
Extended-Release Sodium Oxybate (FT218)
For Narcolepsy with Cataplexy
Emmanuel Mignot, MD, PhD
Assess the long-term safety and tolerability of extended-release sodium oxybate (FT218) and the ability to switch from twice nightly immediate release sodium oxybate or mixed salts oxybate to FT218 for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
a. Are receiving a stable dose of twice- nightly sodium oxybate IR or mixed salts oxybate for at least four weeks and are willing to switch to FT218, OR
b. Have not started treatment with twice nightly sodium oxybate IR or mixed salts oxybate, OR
c. Are treatment naïve to any oxybate therapy (i.e. FT218, twice nightly sodium oxybate IR or mixed salts oxybate)
Subjects have a diagnosis of narcolepsy, (NT1 or NT2)
A diagnosis of sleep apnea where the apnea-hypopnea index AHI is ≥15 and/or current use of CPAP
Any unstable or clinically significant medical and/or psychiatric disorders
Screening Period: 1-4 weeks
Titration period: 1-2 months
Stable dose period: through 24 months
Follow-up period: 1 week