Status and phase
Conditions
Treatments
About
This is a double-blind, placebo-controlled, randomized withdrawal, multicenter study of the efficacy and safety of FT218 with an open-label safety extension period. 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 42 weeks, including the open-label safety extension period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Gina Leone, RN, BSN; Gretchen Richards, MS
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal