Table 2.
Primary efficacy results for the phase III studies and pooled populations at week 12
| Parameter | EASE LID | EASE LID 3 | Pooled | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LS mean change from baseline (SE) | LS mean change from baseline (SE) | LS mean change from baseline (SE) | ||||||||||
| ADS-5102 [n = 63] | Placebo [n = 58] | Treatment differencea [95% CI] | p valueb | ADS-5102 [n = 37] | Placebo [n = 38] | Treatment differencea [95% CI] | p valueb | ADS-5102 [n = 100] | Placebo [n = 96] | Treatment differencea [95% CI] | p valueb | |
| UDysRS total score, absolute | − 15.9 (1.6) | − 8.0 (1.6) | − 7.9 (− 12.5, − 3.3) | 0.0009 | − 20.7 (2.2) | − 6.3 (2.1) | − 14.4 (− 20.4, − 8.3) | < 0.0001 | − 17.7 (1.3) | − 7.6 (1.3) | − 10.1 (− 13.8, − 6.5) | < 0.0001 |
| UDysRS total score, relative, % | − 37.0 (5.8) | − 11.6 (5.9) | − 25.4 (− 41.7, − 9.0) | 0.0027 | − 45.8 (5.2) | − 16.3 (4.9) | − 29.6 (− 43.9, − 15.3) | < 0.0001 | − 41.1 (4.2) | − 13.9 (4.1) | − 27.3 (− 38.7, − 15.8) | < 0.0001 |
| UDysRS historical score (Parts I and II) | − 9.9 (1.0) | − 5.4 (1.0) | − 4.5 (− 7.4, − 1.6) | 0.0027 | − 12.1 (1.5) | − 4.0 (1.4) | − 8.1 (− 12.1, − 4.1) | 0.0001 | − 10.7 (0.86) | − 5.1 (0.84) | − 5.6 (− 8.0, − 3.3) | < 0.0001 |
|
UDysRS objective score (Parts III and IV) |
− 6.1 (0.9) | − 2.7 (1.0) | − 3.4 (− 6.1, − 0.8) | 0.0120 | − 8.7 (1.3) | − 2.2 (1.2) | − 6.5 (− 10.1, − 3.0) | 0.0004 | − 7.0 (0.76) | − 2.5 (0.75) | − 4.5 (− 6.6, − 2.4) | < 0.0001 |
CI confidence interval, LS least squares, SE standard error, UDysRS Unified Dyskinesia Rating Scale
aADS-5102
-
placebo
b P values are based on the comparison of ADS-5102 versus placebo from the mixed effect model repeat measurement model