Adjusted mean change from baseline (SE) | Difference vs placebo (95% CI) | p-values | ||
---|---|---|---|---|
Placebo (n = 152) | Rasagiline 1 mg/day (n = 158) | |||
Primary endpoint (mean change over Weeks 4, 8, 12, and 16; ANCOVA, OC) | ||||
Total daily OFF time, hoursa | − 0.76 (0.16) | −1.25 (0.16) | −0.50 (− 0.92, − 0.07) | 0.023 |
Secondary endpoints (Week 16; ANCOVA, LOCF) | ||||
CGI-Ib | 3.56 (0.07) | 3.15 (0.07) | −0.41 (− 0.61, − 0.22) | < 0.001 |
UPDRS-ADL OFF | −1.20 (0.28) | − 2.21 (0.28) | − 1.01 (− 1.75, − 0.27) | 0.008 |
UPDRS-Motor ON | −1.75 (0.55) | − 3.34 (0.55) | − 1.60 (− 3.05, − 0.14) | 0.032 |
Exploratory analyses (mean change from baseline to Week 16 in total daily OFF time) | ||||
ANCOVA, OC | −0.87 (0.21) (n = 147) | − 1.39 (0.21) (n = 151) | − 0.52 (− 1.06, 0.02) | 0.0602 |
ANCOVA, LOCF | −0.81 (0.20) | − 1.36 (0.20) | −0.55 (− 1.08, − 0.02) | 0.0412 |
MMRM, OC | −0.81 (0.20) | −1.34 (0.20) | − 0.53 (− 1.07, 0.00) | 0.0514 |
PDQ-39 summary index and dimension scores (mean change, SE at Week 16; ANCOVA, OC) | ||||
Summary index | −0.1 (0.8) | −1.9 (0.8) | −1.8 (−3.96, 0.42) | 0.1122 |
Activities of daily living | 2.0 (1.3) | −4.0 (1.3) | −6.1 (−9.52, − 2.64) | < 0.001 |
Bodily discomfort | 1.7 (1.4) | − 2.2 (1.4) | −3.9 (− 7.65, − 0.12) | 0.043 |
Cognition | 0.9 (1.2) | 0.4 (1.2) | −0.6 (−3.77, 2.67) | 0.737 |
Communication | −1.0 (1.2) | 0.1 (1.2) | 1.1 (−2.09, 4.23) | 0.506 |
Emotional well-being | −0.6 (1.5) | −3.0 (1.5) | −2.4 (−6.35, 1.49) | 0.224 |
Mobility | −1.6 (1.2) | −4.1 (1.2) | −2.5 (−5.59, 0.53) | 0.104 |
Social support | −1.2 (1.1) | 0.4 (1.1) | 1.6 (−1.35, 4.53) | 0.288 |
Stigma | −2.2 (1.4) | −4.7 (1.4) | −2.5 (−6.22, 1.32) | 0.202 |
EQ-5D (mean change, SE at Week 16; ANCOVA, OC) | ||||
Utility index | 0.00 (0.02) | 0.05 (0.02) | 0.05 (0.01, 0.09) | 0.024 |
Health statec | 0.77 (1.18) | 5.09 (1.20) | 4.31 (1.18, 7.45) | 0.007 |