Table 1.
Study | NCT number | Study type | Countries | Centers | Publication | Total number of participants | Treatment group | Main outcome events |
---|---|---|---|---|---|---|---|---|
Mignot et al 2022 | NCT03545191 | RCT | 10 | 75 | Lancet Neurology | 930 | ACT-541468: 25 mg, 50 mg vs Placebo | a b c d |
NCT03575104 | RCT | 11 | 81 | Lancet Neurology | 924 | ACT-541468: 10 mg, 25 mg vs Placebo | a b c d | |
Dauvilliers et al 2020 | NCT02841709 | RCT | 6 | 38 | ANNALS of Neurology | 58 | ACT-541468: 5 mg, 10 mg, 25 mg vs Placebo | e f g |
Zammit et al 2020 | NCT02839200 | RCT | 2 | 10 | Neurology | 360 | ACT-541468: 5 mg, 10 mg, 25 mg, 50 mg vs Placebo or 10 mg zolpidem | e f |
(a) Change from baseline to month 1 in Wake After Sleep Onset. (b) Change from baseline to month 3 in Wake After Sleep Onset. (c) Change from baseline to month 1 in Latency to Persistent Sleep. (d) Change from baseline to month 3 in Latency to Persistent Sleep. (e) Change in Wake After Sleep Onset from Baseline to days 1 and 2. (f) Change in latency to persistent sleep from baseline to days 1 and 2. (g) Change in subjective wake after sleep onset and subjective latency to sleep onset from baseline recording to week 4 average.