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. 2021 Aug 6;45(6):zsab200. doi: 10.1093/sleep/zsab200

Figure 1.

Figure 1.

Study design.REST-ON is a 13-week, phase 3, double-blind, multicenter trial with a 1:1 randomization to ON-SXB vs. placebo. Participants receiving ON-SXB underwent a forced titration from 4.5 g (week 1) to 6 g (weeks 2–3) to 7.5 g (weeks 4–8), and finally 9 g (weeks 9–13). Randomization was stratified according to narcolepsy type (NT1/NT2). There was a 3-week baseline screening period before randomization. MWT, number of cataplexy attacks, ESS, and PSG were assessed at baseline and at weeks 3, 8, and 13 of treatment. Number of cataplexy attacks, hypnagogic hallucinations, and sleep paralysis events were recorded in the daily sleep and symptom diaries, which were reviewed at weeks 3, 8, and 13. CGI-S (for sleepiness) was recorded at baseline; CGI-I was recorded at weeks 3, 8, and 13. Adverse events were documented at weeks 3, 8, and 13, but could be reported at any time during the trial. CGI-I, Clinical Global Impression of Improvement; CGI-S, Clinical Global Impression of Severity; ESS, Epworth Sleepiness Scale; MWT, Maintenance of Wakefulness Test; NT1, narcolepsy type 1; NT2, narcolepsy type 2; ON-SXB, once-nightly sodium oxybate; PSG, polysomnography.