Supplementary Table (online only) Responder rates and dosage changes (observed cases, excluding ex-placebo recipients)
Early PD Advanced PD
Preceding DB trial: duration 33 weeks 11–13 weeksa Up to 33 weeks
Preceding DB trial: treatment group DB ER DB IR DB ER DB IR DB ER DB IR
Responder rates,b n/N (%)
UPDRS II+III 76/119 (63.9) 65/115 (56.5) 25/76 (32.9)c 9/37 (24.3)c 64/103 (62.1) 66/111 (59.5)
“Off” time ------67/100 (67.0) 69/108 (63.9)
Mean ER dosage
DB endpoint
Time ------OL Week 0 OL Week 0 OL Week 0 OL Week 0
N ------95 48 123 139
mg/d ------2.75 2.80 2.87 2.85
(SD) ------(0.95) (0.89) (1.38) (1.38)
Completion of OL ER transfer
Time OL Week 8 OL Week 8 ------
N 153 139 ------
mg/d 3.15 3.16 ------
(SD) (1.30) (1.26) ------
OL endpoint
Time OL Week 80 OL Week 80 OL Week 72 OL Week 72 OL Week 80 OL Week 80
N 140 129 84 42 115 126
mg/d 3.14 3.13 2.97 3.07 2.96 3.00
(SD) (1.23) (1.31) (1.05) (1.06) (1.24) (1.38)
Mean levodopa dosage
DB baseline
N ------114 132
mg/d ------552.1 636.5
(SD) ------(268.4) (351.5)
OL baseline
n 13 5 51 26 122 139
mg/d 351.9 177.5 389.7 388.0 571.0 586.4
(SD) (200.6) (75.2) (256.2) (185.8) (548.8) (295.1)
OL endpoint
Time OL Week 80 OL Week 80 OL Week 72 OL Week 72 OL Week 80 OL Week 80
n 29 29 54 30 114 132
mg/d 363.2 229.5 400.5 455.0 572.6 613.8
(SD) (236.3) (194.0) (290.1) (278.5) (371.6) (324.1)
aNot including IR pretreatment for ≥3 months; bDefined by ≥20% improvement from DB baseline to OL endpoint; cAt DB baseline, all subjects had already been taking pramipexole IR for ≥3 months; DB, double-blind; ER, extended-release pramipexole; OL, open-label; PD, Parkinson’s disease; SD, standard deviation; UPDRS, Unified Parkinson’s Disease Rating Scale.