Table 4.
Sleep Parameters from Polysomnography
| Parameter/Arm | Baseline | Treatment | Placebo-adjusted Change from Baseline |
|---|---|---|---|
| TST, min | |||
| Placebo | 386.4 (362.3–428.0) | 399.4 (358.5–426.5) | – |
| Ato75 | 396.4 (364.0–427.0) | 372.2 (340.5–406.0) | −21.46 (−34.3 to −8.59)** |
| AD109 2.5/75 mg | 387.5 (352.8–412.9) | 385.5 (364.8–416.5) | 2.48 (−12.01 to 16.96)†† |
| AD109 5/75 mg | 387.9 (360.9–425.8) | 392.6 (355.5–421.8) | −5.37 (−19.65 to 8.91)† |
| Total arousal index, events/h | |||
| Placebo | 26.9 (21.5–34.7) | 23.7 (18.5–34.1) | – |
| Ato75 | 27.2 (19.5-34.6) | 26.5 (18.3–36.2) | 1.38 (−1.51 to 4.27) |
| AD109 2.5/75 mg | 28.5 (21.5–36.2) | 24.2 (18.5–34.3) | −1.19 (−4.43 to 2.06) |
| AD109 5/75 mg | 29.4 (21.0–37.9) | 24.9 (17.2–31.3) | −2.92 (−6.13, 0.29)† |
| Respiratory arousal index, events/h | |||
| Placebo | 21.6 (15.0 – 28.3) | 18.7 (12.6–26.4) | – |
| Ato75 | 21.6 (13.8–28.4) | 15.1 (7.6–26.7) | −0.92 (−4.00 to 2.16) |
| AD109 2.5/75 mg | 22.0 (16.8–29.8) | 15.6 (11.3–21.8) | −3.08 (−6.54 to 0.38) |
| AD109 5/75 mg | 22.5 (15.4–29.3) | 14.0 (8.4–25.1) | −4.66 (−8.08 to −1.24)* |
| WASO, min | |||
| Placebo | 65.1 (41.5–97.8) | 58.9 (44.5–101.8) | – |
| Ato75 | 70.1 (44.3–98.8) | 92.9 (61–124.3) | 20.32 (8.07 to 32.58)** |
| AD109 2.5/75 mg | 75.6 (56.8–104.3) | 78.9 (56.8–98.3) | 0.11 (−13.69 to 13.91) |
| AD109 5/75 mg | 73.3 (43.3–93.5) | 77.0 (48.3–106.3) | 8.21 (−5.37 to 21.79) |
| Sleep latency, min | |||
| Placebo | 10.6 (6.2–16.7) | 9.8 (5.5–16.9) | – |
| Ato75 | 10.4 (5.2–17.5) | 9.8 (3.8–14.2) | −0.03 (−4.26 to 4.21) |
| AD109 2.5/75 mg | 8.4 (4.7–21.0) | 7.8 (4.8–15.0) | −2.77 (−7.53 to 1.98) |
| AD109 5/75 mg | 10.3 (5.4–25.4) | 10.7 (5.1–18.9) | 0.68 (−4.06 to 5.42) |
| N1, %TST | |||
| Placebo | 13.4 (11.8–19.6) | 14.1 (10.3–18.6) | – |
| Ato75 | 15.5 (12.1–21.8) | 18.7 (15.3–25.1) | 4.21 (2.20 to 6.22)*** |
| AD109 2.5/75 mg | 15.9 (11.8–19.6) | 18.4 (12.8–25.0) | 3.98 (1.73 to 6.24)*** |
| AD109 5/75 mg | 15.2 (10.7–19.8) | 19.6 (15.0–25.3) | 4.18 (1.95 to 6.41)*** |
| N2, %TST | |||
| Placebo | 57.5 (50.6–62.5) | 58.9 (50.6–66.4) | – |
| Ato75 | 53.5 (50.5–61.8) | 61.1 (55.2–70.1) | 4.73 (2.10 to 7.37)*** |
| AD109 2.5/75 mg | 56.1 (49.1–60.5) | 63.7 (57.0–71.2) | 7.40 (4.43 to 10.36)*** |
| AD109 5/75 mg | 55.5 (51.5–61.3) | 63.7 (57.9–71.1) | 6.54 (3.61 to 9.46)*** |
| N3, %TST | |||
| Placebo | 7.9 (3.0–15.1) | 8.3 (2.7–13.3) | – |
| Ato75 | 9.8 (6.5–15.8) | 9.9 (5.1–14.6) | −0.09 (−1.78 to 1.61) |
| AD109 2.5/75 mg | 8.8 (2.7–12.3) | 7.0 (4.3–11.1) | −1.09 (−2.98 to 0.79) |
| AD109 5/75 mg | 8.3 (5.8–16.4) | 9.3 (3.9–16.3) | −0.18 (−2.06 to 1.69) |
| REM sleep, %TST | |||
| Placebo | 17.9 (14.7–20.1) | 17.2 (13.6–20.8) | – |
| Ato75 | 17.8 (13.7–19.0) | 6.8 (3.5–11.3) | −9.32 (−11.14 to −7.50)*** |
| AD109 2.5/75 mg | 18.6 (14.3–23.0) | 7.5 (3.7–12.7) | −9.74 (−11.78 to −7.69)*** |
| AD109 5/75 mg | 17.3 (13.5–20.1) | 5.6 (2.5–10.2) | −10.79 (−12.79 to −8.78)*** |
Definition of abbreviations: Ato75 = atomoxetine 75 mg; N1/N2/N3 = non-REM sleep stage 1/2/3; SOL = sleep onset latency; TST = total sleep time; WASO = wake after sleep onset.
Baseline and treatment data are shown as median (IQR) unless otherwise specified. Placebo-adjusted change from baseline data are shown as LSmean (95% confidence interval).
*
P < 0.01, **P < 0.05 and ***P < 0.001 vs. placebo.
†
P < 0.05 and ††P < 0.01 vs. Ato75.