Table 1 Patient demographics and characteristics at baseline (all-patients-treated set)
Placebo (n = 158) | Rasagiline 1 mg/day (n = 163) | |
|---|---|---|
Age, years | 61.7 (9.9) | 62.7 (8.9) |
Gender, male | 109 (69%) | 103 (63%) |
BMI | 23.2 (3.3) | 23.1 (3.2) |
Education (highest level)a | ||
Elementary/middle school | 67 (44%) | 68 (43%) |
High school | 45 (30%) | 41 (26%) |
College/university/graduate | 33 (22%) | 46 (29%) |
None/other | 7 (5%) | 3 (2%) |
Duration of PD, years | 7.1 (4.3) | 7.4 (4.8) |
Modified Hoehn and Yahr ON | 2.0 (0.7) | 1.9 (0.7) |
Patients with dyskinesia | 31 (20%) | 49 (30%) |
UPDRS-Dyskinesia | 0.35 (0.9) | 0.49 (1.2) |
ON time with troublesome dyskinesia, hours | 0.55 (1.8) | 0.67 (2.0) |
Patients taking concomitant anti-PD medications:b | ||
Anticholinergics | 20 (13%) | 21 (13%) |
Amantadine | 58 (37%) | 50 (31%) |
Dopamine agonistsc | 102 (65%) | 104 (64%) |
COMT inhibitorsd | 31 (20%) | 34 (21%) |
Data for FAS population | (n = 152) | (n = 158) |
Total daily OFF time, hourse | 6.1 (2.7) | 6.1 (2.6) |
Total daily ON time, hourse | 9.3 (2.5) | 9.4 (2.4) |
UPDRS-ADL OFF | 16.5 (7.5) | 15.6 (7.2) |
UPDRS-ADL ON | 7.3 (5.1) | 6.8 (4.6) |
UPDRS-Motor ON | 25.6 (10.5) | 23.8 (10.5) |
CGI-S | 4.1 (0.8) | 3.9 (0.8) |
Total daily levodopa dose, mg | 550 (224) | 501 (222) |
Total daily levodopa dose at end of Week 4, mgf | 549 (225) | 495 (219) |