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Effectiveness and Safety of Low-Sodium Oxybate in Participants with Narcolepsy: Primary Results from the DUET Study.

Effectiveness and Safety of Low-Sodium Oxybate in Participants with Narcolepsy: Primary Results from the DUET Study. Neurology and therapy Schneider, L. D., Ruoff, C. M., Plante, D. T., Nichols, D. A., Steininger, T. L., Fuller, D. S., Kirby, M. T., Akerman, S., Alexander, J. K., Whalen, M., Cairns, A. 2026

Abstract

INTRODUCTION: A phase4, prospective, open-label study of low-sodium oxybate (LXB) in narcolepsy (type1 [NT1] or 2 [NT2]) or idiopathic hypersomnia included novel symptom outcomes important to patients (Jazz DUET; NCT05875974; registered 16 May2023). Primary results from the narcolepsy cohort, including LXB effectiveness (nighttime sleep/daytime symptoms/overall disease severity) and safety are reported here.METHODS: DUET included screening, 8-day baseline (BL; off-LXB), 2-8-week LXB dose titration/optimization, 2-week stable-dose, 8-day end-of-treatment (EOT; on-LXB), and safety follow-up periods. At BL and EOT, participants underwent nocturnal polysomnography (PSG) and completed Epworth Sleepiness Scale (ESS; primary endpoint), Narcolepsy Severity Scale (NSS [NT1]; NSS-2 [NT2]), and Patient Global Impression of Severity (PGI-S) and Change (PGI-C); eDiaries for sleep quality and cataplexy (NT1 only) were completed daily for 8days before PSGs. Least-squares mean (LSM) changes were adjusted for BL values.RESULTS: Thirty-four participants completed the study and were analyzed (NT1, n=16; NT2, n=18); LSM (SE) change in ESS score (BL to EOT),-7.7 (0.9), P<0.0001. At EOT versus BL, transitions to lighter stages of sleep decreased (LSM [SE]-13.1 [2.9], P<0.0001), N3 duration increased (45.0 [8.8] min, P<0.0001), and nocturnal awakenings decreased (-3.2 [0.9], P=0.0013). LSM [SE] changes in NSS and NSS-2 scores were-19.7 (2.7) and -11.3 (1.6). Most participants reported improved sleep quality and overall narcolepsy disease and fewer cataplexy attacks. Treatment-emergent adverse events were consistent with the known LXB safety profile.CONCLUSION: DUET study results demonstrated novel nighttime sleep/daytime symptom improvements in participants with narcolepsy treated with open-label LXB.TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05875974.

View details for DOI 10.1007/s40120-026-00921-3

View details for PubMedID 42060037