Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release
Table 1
Mean changes in UPDRS II, III, and II+III scores according to PGI-I and CGI-I ratings by treatment group in the early PD study.
PGI-I
(%)
UPDRS II
UPDRS III
UPDRS II+III
CGI-I
(%)
UPDRS II
UPDRS III
UPDRS II+III
Pramipexole ER
Very much better
10 (5%)
−3.5 (3.3)
−5.5 (4.9)
−9.0 (6.4)
Very much improved
15 (7%)
−2.7 (3.8)
−8.1 (7.6)
−10.9 (10.2)
Much better
63 (30%)
−3.6 (3.0)
−10.7 (8.4)
−14.4 (10.0)
Much improved
76 (38%)
−3.8 (3.1)
−11.3 (8.5)
−15.1 (10.2)
A little better
59 (28%)
−2.4 (3.3)
−7.9 (8.4)
−10.3 (10.6)
Minimally improved
71 (34%)
−2.5 (2.7)
−7.0 (5.7)
−9.4 (7.1)
No change
45 (21%)
−2.6 (2.8)
−6.3 (5.7)
−8.9 (7.4)
No change
33 (16%)
−0.9 (2.4)
−2.3 (5.4)
−3.3 (6.8)
A little worse
22 (10%)
0.1 (3.0)
−3.0 (4.9)
−2.9 (6.9)
Minimally worse
12 (6%)
1.9 (3.3)
1.5 (6.8)
3.4 (8.8)
Much worse
12 (6%)
0.8 (3.7)
0.6 (6.7)
1.3 (9.4)
Much worse
3 (1%)
2.7 (5.5)
2.3 (5.7)
5.0 (10.5)
Very much worse
1 (0.5%)
0
7
7
Very much worse
0
Pramipexole IR
Very much better
8 (4%)
−5.4 (2.6)
−13.6 (7.5)
−19.0 (9.6)
Very much improved
14 (7%)
−5.5 (2.5)
−14.1 (8.1)
−19.6 (8.9)
Much better
61 (29%)
−3.8 (3.7)
−8.8 (8.3)
−12.6 (10.7)
Much improved
81 (39%)
−3.9 (3.6)
−10.3 (8.5)
−14.1 (10.6)
A little better
73 (35%)
−2.6 (3.3)
−7.8 (8.5)
−10.4 (10.1)
Minimally improved
66 (32%)
−2.1 (3.1)
−5.6 (6.7)
−7.7 (8.2)
No change
44 (21%)
−1.6 (2.9)
−4.8 (8.3)
−6.3 (9.9)
No change
34 (17%)
−0.5 (2.3)
−1.9 (6.8)
−2.4 (7.9)
A little worse
17 (8%)
0.0 (3.0)
−1.9 (5.5)
−1.9 (7.8)
Minimally worse
9 (4%)
0.0 (2.8)
1.6 (5.6)
1.6 (7.2)
Much worse
4 (2%)
0.3 (3.3)
2.3 (4.8)
2.5 (7.0)
Much worse
2 (1%)
3.0 (1.4)
3.5 (2.1)
6.5 (0.7)
Very much worse
0
Very much worse
0
Placebo
Very much better
4 (4%)
−1.8 (3.0)
−7.0 (6.7)
−8.8 (6.4)
Very much improved
2 (2%)
−2.5 (3.5)
−6.0 (4.2)
−8.5 (7.8)
Much better
18 (18%)
−3.4 (2.8)
−6.7 (5.9)
−10.1 (6.9)
Much improved
28 (28%)
−2.3 (2.8)
−6.8 (4.4)
−9.1 (5.1)
A little better
34 (33%)
−1.0 (3.5)
−5.2 (8.4)
−6.2 (10.2)
Minimally improved
31 (30%)
−1.3 (3.4)
−7.3 (7.6)
−8.5 (9.0)
No change
34 (33%)
−0.6 (3.2)
−1.7 (7.1)
−2.3 (8.8)
No change
29 (28%)
−0.5 (3.5)
0.7 (5.7)
0.2 (7.9)
A little worse
10 (10%)
1.7 (3.7)
1.8 (3.3)
3.5 (6.3)
Minimally worse
11 (11%)
1.8 (4.1)
4.1 (6.1)
5.9 (9.5)
Much worse
3 (3%)
0.3 (2.3)
5.3 (2.5)
5.7 (4.7)
Much worse
1 (1%)
2
13
15
Very much worse
0
Very much worse
0
Presented as the mean change in the UPDRS scores (standard deviations). PGI-I: Patient-rated Global Impression of Improvement; CGI-I: Clinician-rated Global Impression of Improvement.
