Table 3 Mean change from baseline to End of Maintenance/End of Treatment for other efficacy variables (Full Analysis Set)
Assessment (possible score range)a | Mean ± SD baseline score | Mean ± SD change from baseline | ||||
|---|---|---|---|---|---|---|
Placebo | Rotigotine low dose | Rotigotine high dose | Placebo | Rotigotine low dose | Rotigotine high dose | |
(n = 40) | (n = 36) | (n = 40) | (n = 40) | (n = 36) | (n = 40) | |
UPDRS Part II in “OFF” (0–52)b | 12.9 ± 6.3 | 12.8 ± 5.1 | 12.7 ± 5.8 | −1.5 ± 3.5 | −3.5 ± 4.5 | −2.6 ± 3.4 |
NMSS total score (0–360)c | 50.1 ± 34.1 | 50.9 ± 31.0 | 58.2 ± 36.8 | −6.7 ± 20.5 | −19.5 ± 21.9 | −20.7 ± 26.2 |
NMSS domain scorec | ||||||
Cardiovascular (0–24) | 1.7 ± 2.5 | 1.3 ± 2.4 | 1.6 ± 2.0 | 0.3 ± 2.2 | 0.2 ± 3.1 | −0.6 ± 1.6 |
Sleep/fatigue (0–48) | 8.1 ± 5.9 | 9.9 ± 6.7 | 10.9 ± 7.5 | 0.9 ± 7.3 | −3.0 ± 7.3 | −3.5 ± 6.5 |
Perception/hallucination (0–36) | 0.6 ± 2.0 | 0.2 ± 1.0 | 0.4 ± 1.5 | 0.1 ± 1.6 | 0.3 ± 1.2 | 0.1 ± 2.0 |
Attention/memory (0–36) | 5.7 ± 5.2 | 5.1 ± 4.7 | 5.6 ± 5.8 | −1.2 ± 3.6 | −2.2 ± 4.5 | 0.6 ± 5.9 |
Gastrointestinal tract (0–36) | 3.8 ± 4.1 | 2.8 ± 3.5 | 3.9 ± 4.0 | 0.4 ± 4.0 | −0.7 ± 3.8 | −1.4 ± 3.6 |
Urinary (0–36) | 6.3 ± 7.6 | 5.5 ± 6.1 | 6.7 ± 7.7 | −0.6 ± 5.8 | −0.3 ± 6.9 | −0.7 ± 4.8 |
Sexual function (0–24) | 5.5 ± 7.7 | 5.9 ± 7.5 | 6.5 ± 8.7 | −1.4 ± 5.8 | −2.8 ± 5.4 | −2.3 ± 7.6 |
Miscellaneous (0–48) | 5.1 ± 6.5 | 4.4 ± 6.6 | 7.0 ± 7.9 | −0.7 ± 4.3 | −1.2 ± 4.0 | −3.2 ± 6.2 |
FSS (9–63)c | 41.9 ± 13.09 | 40.4 ± 11.08 | 43.6 ± 12.38 | −2.8 ± 11.74 | −6.6 ± 13.10 | −5.7 ± 8.87 |
MoCA (0–30)c | 26.4 ± 3.43 | 25.1 ± 3.29 | 24.8 ± 4.23 | 0.2 ± 2.24 | 0.4 ± 2.58 | 0.3 ± 3.90 |
Score at EoT, n (%) | ||||||
PGICc | ||||||
Improved | — | — | — | 11 (27.5) | 14 (38.9) | 16 (40.0) |
No change | — | — | — | 28 (70.0) | 16 (44.4) | 20 (50.0) |
Worsened | — | — | — | 0 | 0 | 2 (5.0) |
Missing | — | — | — | 1 (2.5) | 6 (16.7) | 2 (5.0) |