Table 1.
Baseline demographics and disease characteristics.
| Characteristic | Safety Populationa | OLE Safety Populationb |
|---|---|---|
| (n = 154) | (n = 106) | |
| Age, mean (SD), y | 40.3 (13.7) | 41.0 (13.8) |
| Female, n (%) | 105 (68) | 75 (71) |
| Body mass index, mean (SD), kg/m2 | 27.4 (7.4) | 27.7 (8.2) |
| Race, n (%) | ||
| White | 129 (84) | 88 (83) |
| Black or African-American | 9 (6) | 6 (6) |
| Otherc | 16 (10) | 12 (11) |
| Treatment at study entry, n (%) | ||
| Alerting agentd | 82 (53) | 60 (57) |
| Treatment naive | 66 (43) | 41 (39) |
| SXB | 2 (1) | 2 (2) |
| SXB + alerting agentd | 4 (3) | 3 (3) |
| Idiopathic hypersomnia diagnosis, n (%) | ||
| With long sleep | 31 (20) | 21 (19.8) |
| Without long sleep | 123 (80) | 85 (80.2) |
| Baseline ESS score, mean (SD) | 16.1 (3.6) | 15.8 (3.7) |
| Baseline IHSS total score, mean (SD) | 32.1 (8.0) | 31.6 (8.2) |
aIncludes all participants who took at least 1 dose of study drug. bIncludes all participants who received at least 1 dose of study drug during OLE. cIncludes declined to state. dAlerting agents include stimulants and wake-promoting agents. ESS = Epworth Sleepiness Scale, IHSS = Idiopathic Hypersomnia Severity Scale, OLE = open-label extension period, SXB = high-sodium oxybate.