Effectiveness and Safety of Low-Sodium Oxybate in Participants with Idiopathic Hypersomnia: Primary Results from the DUET Study
Abstract
Background and objectives: Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) was a phase 4, prospective, multicenter, single-arm, open-label, multiple-cohort study of individuals with idiopathic hypersomnia or narcolepsy evaluating safety and effectiveness of low-sodium oxybate (LXB; Xywav®) treatment on sleep and daytime symptoms. Results from the idiopathic hypersomnia cohort are reported here.
Methods: The DUET study included a screening period (with a 2-week washout for current oxybate users), an 8-day baseline (BL) period, a 2- to 8-week LXB titration period, a 2-week stable-dose period, an 8-day end-of-treatment period (EOT) period, and a 2-week safety follow-up. The primary endpoint was the change in Epworth Sleepiness Scale (ESS) score from BL to EOT. Secondary endpoints for the idiopathic hypersomnia cohort included change in Idiopathic Hypersomnia Severity Scale (IHSS) total score; Patient Global Impression of Change (PGI-C) and Severity (PGI-S) for overall idiopathic hypersomnia disease, sleep inertia, and fatigue; and changes in sleep quality and feeling rested upon awakening (from self-reported daily sleep diary). Exploratory outcomes included sleep patterns measured by actigraphy, the British Columbia Cognitive Complaints Inventory, Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), and Work Productivity and Activity Impairment Questionnaire: Specific Health Problem. Incidence and severity of treatment-emergent…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 40 participants or records.
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