Sponsor Name: Flamel Ireland Ltd d/b/a Avadel Ireland
Protocol Title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-Label Safety Extension
Protocol Number: CLFT218-2401
Regulatory Agency Identifier Numbers: IND: 168810
Brief Summary: This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218. FT218 drug product is a once-nightly formulation of sodium oxybate for extended-release oral suspension. The study will enroll subjects who are diagnosed with idiopathic hypersomnia. Subjects will be eligible to enroll regardless of current treatment with oxybate therapy or stimulants/alerting agents at study entry. The estimated total duration of study for each subject is approximately 18 weeks, including the Screening period.
https://clinicaltrials.gov/study/NCT06525077