Correlation Between Maintenance of Wakefulness Test and Epworth Sleepiness Scale Scores in REST-ON

Document Type

Conference Proceeding

Publication Date

5-19-2025

Publication Title

Sleep

Abstract

Introduction: Low-to-moderate strength correlations between Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) scores have been reported in clinical trials in narcolepsy. This post hoc analysis of REST-ON (NCT02720744), which demon strated the efficacy of once-nightly sodium oxybate (ON-SXB; LUMRYZ™) for narcolepsy, assessed the correlation between mean sleep latency (MSL) on the MWT and ESS scores. Methods: REST-ON participants (age ≥16 years) with narco lepsy were randomized 1:1 to ON-SXB (week 1, 4.5 g; weeks 2-3, 6 g; weeks 4-8, 7.5 g; weeks 9-13, 9 g) or placebo. Pearson correlation coefficients assessed the relationship between MSL (min) on the MWT and ESS score by treatment arm in the modi fied intent-to-treat (mITT) population (≥1 efficacy measurement after receiving the 6-g dose) at baseline (pretreatment) and weeks 3 (6 g), 8 (7.5 g), and 13 (9 g). Results: In the mITT population (ON-SXB, n=97; placebo, n=93), respective baseline MSL (SD) on the MWT and baseline mean (SD) ESS score was 5.0 (3.1) and 16.6 (3.8) for ON-SXB and 4.7 (2.6) and 17.5 (4.1) for placebo. At baseline, no correla tion was observed between MSL on the MWT and ESS score for either arm (ON-SXB, r=0.015; placebo, r=–0.023). At weeks 3, 8, and 13, respective MSL (SD) was 13.1 (8.8), 14.5 (9.8), and 15.5 (9.8) minutes and respective ESS scores were 13.3 (5.9), 11.6 (6.1), and 10.4 (6.2) for ON-SXB; for placebo, MSL (SD) was 7.8 (5.9), 7.8 (6.3), and 9.4 (7.9) minutes, with ESS scores of 16.6 (4.6), 15.4 (5.3), and 14.9 (5.5). Moderate strength correlations between MSL on the MWT and ESS scores were observed in the ON-SXB arm (r=–0.419, –0.305, –0.394 at weeks 3, 8, 13, respectively). Weak correlations were observed in the placebo group (r= –0.193, –0.271, –0.181 at weeks 3, 8, 13, respectively). Conclusion: After initiating ON-SXB treatment, the correlation between MWT and ESS scores strengthened, suggesting that improved wakefulness enhances awareness of sleepiness levels in people with narcolepsy.

Volume

48

First Page

A373

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