Mar 17 2025
REVITALYZ Study
h in Clinical Trial
REVITALYZ aims to understand how well FT218 works to reduce excessive daytime sleepiness in adults with idiopathic hypersomnia (IH). The study will also assess the safety of FT218 in IH. About 150 adults are expected to participate and can be enrolled now at clinical sites across the U.S.
FT218 is an extended-release form of sodium oxybate. It is taken as an oral suspension, once at bedtime. In the REVITALYZ study, all participants will receive FT218 until they reach a stable dose; half of the participants will then continue with FT218, and half will receive a placebo (which looks like the study drug but contains no medicine). Study participation is voluntary and lasts up to 18 weeks. Further information about eligibility and clinical study sites are available at https://www.revitalyz.com/eligibility