Assessment (possible score range)a | Mean ± SD baseline score | LS mean ± SE change from baseline | LS mean (95 % CI) difference to placebo | |||||
---|---|---|---|---|---|---|---|---|
Placebo (n = 40) | Rotigotine low dose (n = 36) | Rotigotine high dose (n = 40) | Placebo (n = 40) | Rotigotine low dose (n = 36) | Rotigotine high dose (n = 40) | Rotigotine low dose (n = 36) | Rotigotine high dose (n = 40) | |
Secondary efficacy variables | ||||||||
AS as rated by caregiver (0–42)b | 18.4 ± 8.1 | 19.3 ± 6.2 | 19.6 ± 6.9 | −2.50 ± 1.97 | −5.71 ± 2.30 | −5.55 ± 2.05 | −3.20 (−8.17, 1.76) p = 0.200 | −3.04 (−8.19, 2.10) p = 0.239 |
PDQ-8 total (0–100)b | 29.1 ± 20.1 | 27.3 ± 18.3 | 31.6 ± 18.1 | −3.29 ± 2.42 | −5.37 ± 2.54 | −8.34 ± 2.39 | −2.09 (−8.48, 4.31) p = 0.519 | −5.06 (−11.29, 1.17) p = 0.111 |
NMSS “mood/apathy” domain (0–72)c | 13.5 ± 10.7 | 15.8 ± 11.2 | 15.6 ± 11.8 | −4.84 ± 1.41 | −8.46 ± 1.50 | −8.72 ± 1.37 | −3.62 (−7.39, 0.15) p = 0.060 | −3.88 (−7.46, −0.30) p = 0.034 |
SHAPS (0–14)b | 1.6 ± 2.1 | 2.1 ± 2.4 | 2.1 ± 2.5 | −1.09 ± 0.29 | −1.48 ± 0.31 | −1.08 ± 0.29 | −0.38 (−1.16, 0.40) p = 0.334 | 0.02 (−0.74, 0.77) p = 0.968 |
BDI-II total (0–63)c | 12.8 ± 7.0 | 13.9 ± 7.2 | 12.0 ± 5.8 | −2.66 ± 0.93 | −2.50 ± 1.00 | −2.99 ± 0.90 | 0.16 (−2.34, 2.66) p = 0.899 | −0.33 (−2.68, 2.03) p = 0.785 |
UPDRS Part III in “ON” (0–108)b | 27.5 ± 14.0 | 31.6 ± 10.7 | 27.0 ± 8.4 | −3.13 ± 1.50 | −8.09 ± 1.55 | −7.96 ± 1.49 | −4.96 (−8.91, −1.01) p = 0.014 | −4.83 (−8.63, −1.03) p = 0.013 |
Post hoc analysis of single items from NMSS “mood/apathy” domain | ||||||||
Item 7: Lost interest in surroundings (0–12) | 2.2 ± 2.1 | 2.5 ± 2.5 | 2.6 ± 3.0 | −1.12 ± 0.306 | −1.78 ± 0.325 | −1.64 ± 0.297 | −0.66 (−1.48, 0.16) p = 0.1137 | −0.52 (−1.30, 0.25) p = 0.1839 |
Item 8: Lost interest in doing things (0–12) | 3.7 ± 3.1 | 3.9 ± 2.7 | 4.4 ± 3.4 | −0.96 ± 0.465 | −1.97 ± 0.495 | −2.41 ± 0.452 | −1.01 (−2.25, 0.23) p = 0.1093 | −1.45 (−2.63, −0.26) p = 0.0173 |
Item 11: Has flat moods (0–12) | 1.7 ± 1.9 | 2.7 ± 2.6 | 2.6 ± 3.2 | −1.11 ± 0.283 | −1.43 ± 0.301 | −1.61 ± 0.274 | −0.32 (−1.08, 0.45) p = 0.4110 | −0.49 (−1.22, 0.23) p = 0.1785 |
Item 12: Difficulty experiencing pleasure (0–12) | 2.7 ± 3.3 | 2.6 ± 2.9 | 2.2 ± 2.2 | −0.97 ± 0.342 | −1.78 ± 0.365 | −1.31 ± 0.332 | −0.81 (−1.72, 0.11) p = 0.0823 | −0.34 (−1.21, 0.53) p = 0.4411 |
Combined score of the 4 apathy items: 7, 8, 11, and 12 (0–48) | 10.3 ± 7.9 | 11.7 ± 8.3 | 11.8 ± 9.5 | −3.97 ± 0.979 | −7.11 ± 1.043 | −7.06 ± 0.952 | –3.14 (−5.76, −0.51) p = 0.0196 | −3.09 (−5.58, −0.60) p = 0.0156 |
Item 9: Feels nervous, worried for no reason (0–12) | 1.0 ± 1.5 | 1.7 ± 2.1 | 1.8 ± 3.0 | −0.23 ± 0.324 | −0.01 ± 0.345 | −0.46 ± 0.315 | 0.22 (−0.65, 1.09) p = 0.6129 | −0.23 (−1.06, 0.60) p = 0.5785 |
Item 10: Seems sad or depressed (0–12) | 2.3 ± 3.3 | 2.4 ± 3.1 | 2.1 ± 2.6 | −0.75 ± 0.400 | −1.23 ± 0.427 | −1.14 ± 0.390 | −0.48 (−1.55, 0.59) p = 0.3757 | −0.38 (−1.40, 0.63) p = 0.4568 |