Poster
126
(#126) Self-Reported Cognitive Complaints and Work Productivity in Participants With Narcolepsy After Low-Sodium Oxybate Treatment: Results From the Phase 4 DUET Study
Psych Congress 2025
Abstract: Objective: This analysis evaluated the effectiveness of low-sodium oxybate (LXB; Xywav®) on cognitive complaints, work productivity, and daily activities in participants with narcolepsy.
Background: Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) was a phase 4, prospective, multicenter, single-arm, open-label, multiple-cohort study (NCT05875974) in people with narcolepsy or idiopathic hypersomnia. Idiopathic hypersomnia results are reported separately.
Design/Methods: DUET comprised the following periods: screening (2-week washout for current oxybate users), 8-day baseline (BL), 2- to 8-week LXB titration, 2-week stable dose, 1- to 2-week end-of-treatment (EOT), 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) were exploratory outcomes.
Results: Fifty-five participants with narcolepsy (72.7% female; 80.0% White; mean±SD age, 33.4±12.9 years; 13 taking oxybate before washout) enrolled and took ≥1 dose of LXB after BL. Mean (SE) BC-CCI total score (N=34) improved from BL (8.9 [0.7]) to EOT (4.6 [0.6]; change score: −4.2 [0.7]). Cognitive complaint ratings (BL vs EOT) were "none or minimal" (14.7% vs 52.9%), "mild" (35.3% vs 32.4%), "moderate" (41.2% vs 14.7%), or "severe" (8.8% vs 0%). Mean (SE) WPAI:SHP changes (BL to EOT) were −12.5% (4.5%) for absenteeism, −33.0% (4.1%) for presenteeism, and −36.1% (4.6%) for overall work impairment due to narcolepsy (all N=23), and −23.7% (4.6%) for activity impairment (N=30). Treatment-emergent adverse events were consistent with the known LXB safety profile.
Conclusions: Open-label LXB treatment was associated with improvements in cognitive complaints, work productivity, and daily activities in participants with narcolepsy.
Short Description: Jazz DUET was a phase 4, prospective, multicenter, single-arm, open-label, multiple-cohort study evaluating the effectiveness of low-sodium oxybate (LXB) on daytime symptoms and functional impacts in narcolepsy or idiopathic hypersomnia. In participants with narcolepsy, open-label LXB treatment was associated with improvements in cognitive complaints (British Columbia Cognitive Complaints Inventory) and work productivity and daily activities (Work Productivity and Activity Impairment Questionnaire: Specific Health Problem). Treatment-emergent adverse events were consistent with the known LXB safety profile.
Name of Sponsoring Organization(s): Jazz Pharmaceuticals
Background: Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) was a phase 4, prospective, multicenter, single-arm, open-label, multiple-cohort study (NCT05875974) in people with narcolepsy or idiopathic hypersomnia. Idiopathic hypersomnia results are reported separately.
Design/Methods: DUET comprised the following periods: screening (2-week washout for current oxybate users), 8-day baseline (BL), 2- to 8-week LXB titration, 2-week stable dose, 1- to 2-week end-of-treatment (EOT), 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) were exploratory outcomes.
Results: Fifty-five participants with narcolepsy (72.7% female; 80.0% White; mean±SD age, 33.4±12.9 years; 13 taking oxybate before washout) enrolled and took ≥1 dose of LXB after BL. Mean (SE) BC-CCI total score (N=34) improved from BL (8.9 [0.7]) to EOT (4.6 [0.6]; change score: −4.2 [0.7]). Cognitive complaint ratings (BL vs EOT) were "none or minimal" (14.7% vs 52.9%), "mild" (35.3% vs 32.4%), "moderate" (41.2% vs 14.7%), or "severe" (8.8% vs 0%). Mean (SE) WPAI:SHP changes (BL to EOT) were −12.5% (4.5%) for absenteeism, −33.0% (4.1%) for presenteeism, and −36.1% (4.6%) for overall work impairment due to narcolepsy (all N=23), and −23.7% (4.6%) for activity impairment (N=30). Treatment-emergent adverse events were consistent with the known LXB safety profile.
Conclusions: Open-label LXB treatment was associated with improvements in cognitive complaints, work productivity, and daily activities in participants with narcolepsy.
Short Description: Jazz DUET was a phase 4, prospective, multicenter, single-arm, open-label, multiple-cohort study evaluating the effectiveness of low-sodium oxybate (LXB) on daytime symptoms and functional impacts in narcolepsy or idiopathic hypersomnia. In participants with narcolepsy, open-label LXB treatment was associated with improvements in cognitive complaints (British Columbia Cognitive Complaints Inventory) and work productivity and daily activities (Work Productivity and Activity Impairment Questionnaire: Specific Health Problem). Treatment-emergent adverse events were consistent with the known LXB safety profile.
Name of Sponsoring Organization(s): Jazz Pharmaceuticals
