Self-Reported Cognitive Complaints and Work Productivity in Participants With Narcolepsy or Idiopathic Hypersomnia After Low-Sodium Oxybate Treatment: Results From the Phase 4 DUET Study
Logan Schneider1, Chad Ruoff2, Deborah A. Nichols3, Teresa Steininger3, Douglas Fuller3, M. Todd Kirby4, Sarah Akerman3, Jessica Alexander3, David Plante5, Alyssa Cairns6
1Stanford University Center for Sleep Sciences and Medicine, 2Mayo Clinic, Division of Pulmonary Medicine, Center for Sleep Medicine, 3Jazz Pharmaceuticals, 4Jazz Pharmaceuticals, Medical College of Georgia at Augusta University, 5University of Wisconsin-Madison and Medical Director of the Wisconsin Institute for Sleep and Consciousness, 6BioSerenity, Inc
Objective:
This study evaluated the effectiveness of low-sodium oxybate (LXB; Xywav®) on daytime symptoms and functional impacts, including cognitive complaints and work productivity, in participants with narcolepsy or idiopathic hypersomnia (IH).
Background:
Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, open-label, multiple-cohort study (NCT05875974).
Design/Methods:
DUET comprised a screening period (2-week washout for current oxybate users), 8-day baseline (BL) period, 2- to 8-week LXB titration period, 2-week stable-dose period, 1- to 2-week end-of-treatment (EOT) period, and 2-week safety follow-up. The British Columbia Cognitive Complaints Inventory (BC-CCI) and Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), both exploratory outcomes, were administered at BL and EOT.
Results:
Fifty-five participants with narcolepsy (72.7% female; 80.0% White) and 46 with IH (80.4% female; 85.0% White) took ≥1 dose of LXB after BL. BC-CCI total score improved from BL to EOT for narcolepsy, n=34 (mean [SD]: 8.9 [4.2] to 4.6 [3.4]; change score: −4.2 [4.0]) and IH, n=40 (10.1 [4.7] to 5.3 [4.4]; change score: −4.8 [4.0]). For narcolepsy, ratings of cognitive complaints at BL vs EOT, respectively, were “none or minimal,” 5 (14.7%) vs 18 (52.9%); “mild,” 12 (35.3%) vs 11 (32.4%); “moderate,” 14 (41.2%) vs 5 (14.7%); or “severe,” 3 (8.8%) vs 0 (0%). Respective cognitive complaint ratings for IH were “none or minimal,” 6 (15.0%) vs 19 (47.5%); “mild,” 11 (27.5%) vs 14 (35.0%); “moderate,” 16 (40.0%) vs 5 (12.5%); or “severe,” 7 (17.5%) vs 2 (5.0%). For WPAI:SHP, mean (SD) changes from BL to EOT were −36.1% (22.2%) and −32.4% (24.6%) for overall work impairment due to narcolepsy and IH, respectively. Treatment-emergent adverse events were consistent with the known LXB safety profile.
Conclusions:
Open-label LXB treatment was associated with improvements in cognitive complaints and work productivity in participants with narcolepsy or IH.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.