Efficacy parameter | Change from baseline | Difference vs. placebo (95% CI) | P value | |
---|---|---|---|---|
Placebo (n = 63) | Rasagiline 1 mg (n = 64) | |||
Primary efficacy | ||||
UPDRS total score | -0.18 ± 0.98 | −3.18 ± 0.95 | − 3.00 (− 5.62 to − 0.38) | 0.025 |
Secondary efficacy | ||||
UPDRS part I | 0.08 ± 0.15 | − 0.54 ± 0.15 | −0.62 (− 1.03 to − 0.21) | 0.003 |
UPDRS part II | 0.25 ± 0.38 | −0.43 ± 0.37 | −0.67 (− 1.70 to 0.35) | 0.196 |
UPDRS part III | −0.52 ± 0.68 | − 2.23 ± 0.65 | − 1.71 (− 3.52 to 0.10) | 0.064 |
Exploratory efficacy | ||||
Percent respondersa | 42 (66.7) | 51 (79.7) | 0.051 | |
Odds ratio (95% CI) | 2.55 (1.00 to 6.54) | |||
CGI-S score | 0.08 ± 0.08 | 0.04 ± 0.08 | −0.04 (− 0.25 to 0.17) | 0.699 |
CGI-I score | 3.88 ± 0.11 | 3.68 ± 0.11 | − 0.20 (− 0.50 to 0.10) | 0.196 |