Table 1.

Safinamide 100 mg vs. placebo (pooled data): Change from baseline and differences in change from baseline in ON time with no or non-troublesome dyskinesia (Primary endpoint). Least-squares estimates of mean for the pooled ITT population and its stratifications

Studies 016 and SETTLE	Change with		Change with Placebo		Difference	P Value
	Safinamide 100 mg (h)		(h)		Safinamide vs. Placebo
	n	mean [95% CI]	n	mean [95% CI]	mean [95% CI]
Pooled data (ITT pop.)	487	1.42 [1.21, 1.64]	484	0.58 [0.37, 0.80]	0.84 (0.54±1.15)	<0.0001
Levodopa (a) only	43	1.49 [0.79, 2.19]	46	0.33 [–0.34, 1.01]	1.16 (0.18±2.13)	0.0206
Levodopa (a) and other meds.	444	1.42 [1.20, 1.65]	438	0.61 [0.38, 0.83]	0.82 (0.50±1.14)	<0.0001
No use of dopamine agonist	156	1.37 [1.02, 1.72]	149	0.49 [0.13, 0.85]	0.88 (0.38±1.38)	0.0006
Use of dopamine agonist	331	1.47 [1.20, 1.73]	335	0.60 [0.34, 0.87]	0.86 (0.48±1.24)	<0.0001
No use of COMT inhibitor	265	1.34 [1.05, 1.64]	263	0.46 [0.16, 0.75]	0.89 (0.47±1.31)	<0.0001
Use of COMT inhibitor	222	1.52 [1.20, 1.83]	221	0.74 [0.42, 1.05]	0.78 (0.33±1.23)	0.0007
No use of amantadine	373	1.37 [1.14, 1.60]	374	0.53 [0.29, 0.76]	0.84 (0.51±1.17)	<0.0001
Use of amantadine	114	1.60 [1.09, 2.11]	110	0.77 [0.25, 1.29]	0.83 (0.10±1.57)	0.0262
Mild Fluctuators (b)	152	0.94 [0.59, 1.30]	134	0.22 [–0.15, 0.60]	0.72 (0.21±1.23)	0.0062
Non-Mild Fluctuators (b)	335	1.62 [1.36, 1.89]	350	0.74 [0.47, 1.00]	0.89 (0.51±1.26)	<0.0001

ITT = intention to treat; CI = confidence interval; h = hours; n = number of patients.