Evaluating Expanded Once- and Twice-Nightly Xywav Dosing Compared to Placebo in Adults with Narcolepsy or Idiopathic Hypersomnia

What This Trial Is About

Researchers are evaluating the effectiveness and safety of expanded dosing schedules of Xywav in adults with narcolepsy or idiopathic hypersomnia IH. This Phase 3 trial compares different dosing regimens of Xywav to placebo to better understand treatment options for these sleep disorders. The study is sponsored by Jazz Pharmaceuticals and focuses on adult participants aged 18 to 75 years. Participants will undergo three treatment phases an open-label titration and optimization period OL-TOP lasting up to 12 weeks to establish a stable dose of Xywav, followed by a stable dose period SDP of 2 weeks where they continue the stable dose. Finally, participants enter a double-blind randomized withdrawal period DBRWP for 2 weeks, where they are randomly assigned to continue their Xywav dose or switch to placebo. The expanded dosing regimens include once-nightly or twice-nightly doses based on prior treatment and investigator decision. Total treatment duration can be up to 16 weeks. During the trial, participants will be regularly assessed for sleepiness using the Epworth Sleepiness Scale and other sleep-related measures. Researchers will also monitor cataplexy frequency, sleep quality, and symptom severity through questionnaires and clinical evaluations. Safety will be tracked by recording adverse events. Participants will be closely followed throughout the treatment periods, with outcome measures taken at the end of each phase to evaluate the effects of the expanded dosing regimens.

A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH