Table 2.
Summary of endpoints for the ITT population.
| Tasimelteon 20 mg | Placebo | Difference | P-value | |
|---|---|---|---|---|
| (N = 159) | (N = 159) | (95% CI) | ||
| Primary Endpoint | ||||
| TST2/3 (min) | 216.4 | 156.1 | 60.3 (44.0 to 76.7) | P < 0.0001 |
| Objective Secondary Endpoints | ||||
| WASO (min) | 144.6 | 219.1 | −74.6 (−94.8 to −54.3) | P < 0.0001 |
| LPS (min) | 21.8 | 36.8 | −15.1 (−26.2 to −4.0) | P = 0.0081 |
| TSTfull (min) | 315.8 | 230.3 | 85.5 (64.3 to 106.6) | P < 0.0001 |
| TSTfirstthird (min) | 124.6 | 102.4 | 22.2 (14.1 to 30.3) | P < 0.0001 |
| TSTsecondthird (min) | 91.8 | 53.7 | 38.1 (26.7 to 49.5) | P < 0.0001 |
| TSTfinalthird (min) | 99.4 | 74.2 | 25.1 (13.8 to 36.5) | P < 0.0001 |
| Subjective Secondary Endpoints | ||||
| Average Night 1 KSS (pt) | 4.0 | 4.5 | −0.5 (−0.9 to −0.1) | P = 0.0083 |
| Average Night 1 VAS (mm) | 60.8 | 54.2 | 6.6 (1.6 to 11.6) | P = 0.0099 |
| Subjective WASO (min) | 75.3 | 113.5 | −38.2 (−64.2 to −12.2) | P = 0.0041 |
| Subjective Sleep Latency (min) | 27.0 | 40.9 | −13.9 (−29.8 to 2.0) | P = 0.0857 |
| Subjective TST (min) | 393.6 | 331.9 | 61.7 (34.5 to 88.9) | P < 0.0001 |
| No. Nocturnal Awakenings | 2.6 | 2.8 | −0.3 (−0.7 to 0.2) | P = 0.2389 |
| Subjective Sleep Quality (pt) | 3.3 | 2.7 | 0.6 (0.3 to 0.9) | P = 0.0001 |
Data are average measurements recorded by polysomnography for the primary and objective endpoints and recorded by questionnaire for the subjective endpoints. Tasimelteon treatment resulted in significant improvements in objective and subjective sleep time, wake after sleep onset, latency to persistent sleep, and next day alertness as measured by KSS and VAS.
TST2/3, Total Sleep Time in the first 2/3 of the night; TST, Total Sleep Time; WASO, Wake After Sleep Onset; LPS, Latency to Persistent Sleep; KSS, Karolinska Sleepiness Scale; VAS, Visual Analog Scale; No., Number.