COMPARISON OF DEMOGRAPHICS AND BASELINE NARCOLEPSY SYMPTOMS BETWEEN PARTICIPANTS WITH NT1 AND NT2 FROM REST-ON
Recommended Citation
Dauvilliers Y, Roth T, Thorpy MJ, Morse AM, Kushida CA, Harsh J, Ortiz LE, Gudeman J. COMPARISON OF DEMOGRAPHICS AND BASELINE NARCOLEPSY SYMPTOMS BETWEEN PARTICIPANTS WITH NT1 AND NT2 FROM REST-ON. Sleep 2024; 47:A276.
Document Type
Conference Proceeding
Publication Date
5-1-2024
Publication Title
Sleep
Abstract
Introduction: Narcolepsy is classified into 2 subtypes: narcolepsy type 1 (NT1; with cataplexy) and 2 (NT2; without cataplexy). Limited data are available regarding subtype differences in clinical characteristics and disease severity. In the phase 3 REST-ON trial, once-nightly sodium oxybate (ON-SXB; LUMRYZ™) demonstrated significant improvement in the 3 coprimary endpoints of change from baseline in mean sleep latency on the Maintenance of Wakefulness test (MWT), Clinical Global Impression of Improvement rating, and weekly cataplexy episodes (all P< 0.001) in patients with NT1 and NT2. This post hoc analysis compared baseline characteristics between participants with NT1 and NT2. Methods: REST-ON (NCT02720744) participants were ≥16 years of age with NT1 or NT2, excessive daytime sleepiness, and cataplexy (NT1 only). Use of alerting agents was permitted. Randomization (1:1 to ON-SXB or placebo) was stratified by narcolepsy type; the trial population was oversampled for NT1. Baseline characteristics were compared between narcolepsy types. Results: The safety population included 212 participants (NT1, n=162; NT2, n=50). At baseline, demographic characteristics of participants with NT1 vs NT2 were: mean (SD) age, 32.1 (11.1) vs 28.3 (10.0) years, respectively; sex, 72.8% vs 52.0% female; body mass index, 28.9 (7.5) vs 25.7 (5.6) kg/m2; and use of concurrent alerting agents, 59.2% vs 68.0%. Mean (SD) baseline clinical characteristics in participants with NT1 vs NT2 were: mean sleep latency (MWT), 4.9 (2.9) vs 4.9 (2.9) minutes; Clinical Global Impression rating (CGI-Severity), 5.2 (1.1) vs 4.7 (1.1); ESS scores, 17.6 (4.0) vs 15.4 (3.2); number of sleep stage shifts to lighter stage of sleep or wake measured by polysomnography (PSG), 61.5 (22.2) vs 55.8 (23.5); number of nocturnal arousals by PSG, 81.5 (42.4) vs 73.2 (35.9); sleep quality (visual analog scale [VAS; 1 = did not sleep and 100 = slept very well]), 54.5 (22.0) vs 55.8 (20.8); and refreshing nature of sleep (VAS; 1 = not refreshed and 100 = refreshed), 49.9 (22.6) vs 42.6 (21.6). Conclusion: Limited data are available comparing NT1 and NT2 populations; these data indicate a similar level of disease severity at baseline.
Volume
47
First Page
A276
