Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release
Table 3
Mean changes in OFF time according to PGI-I and CGI-I ratings by treatment group in the advanced PD study.
PGI-I
(%)
OFF time hrs (S.D.)
CGI-I
(%)
OFF time hrs (S.D.)
Pramipexole ER
Very much better
9 (6%)
−2.9 (2.5)
Very much improved
9 (6%)
−2.8 (2.2)
Much better
51 (33%)
−2.5 (3.2)
Much improved
69 (41%)
−2.7 (3.2)
A little better
66 (41%)
−2.0 (2.8)
Minimally improved
51 (32%)
−1.7 (2.8)
No change
20 (13%)
−1.3 (2.9)
No change
22 (14%)
−1.0 (3.0)
A little worse
13 (8%)
−0.6 (3.9)
Minimally worse
7 (4%)
1.3 (3.6)
Much worse
1 (0.6%)
5.3
Much worse
1 (0.6%)
0.3
Very much worse
0
Very much worse
0
Pramipexole IR
Very much better
10 (6%)
−4.4 (1.6)
Very much improved
11 (7%)
−3.6 (2.7)
Much better
66 (39%)
−3.2 (2.6)
Much improved
77 (46%)
−3.3 (2.5)
A little better
55 (32%)
−2.3 (2.2)
Minimally improved
55 (33%)
−2.1 (2.2)
No change
27 (16%)
−1.2 (2.7)
No change
19 (11%)
−0.9 (2.8)
A little worse
10 (6%)
−1.4 (3.8)
Minimally worse
4 (2%)
0.5 (4.2)
Much worse
3 (2%)
2.3 (5.6)
Much worse
3 (2%)
2.7 (5.3)
Very much worse
0
Very much worse
0
Placebo
Very much better
3 (2%)
−5.1 (3.6)
Very much improved
6 (4%)
−4.4 (3.2)
Much better
44 (25%)
−1.9 (3.1)
Much improved
50 (29%)
−2.3 (2.2)
A little better
65 (37%)
−1.5 (3.4)
Minimally improved
66 (39%)
−0.9 (2.9)
No change
43 (25%)
−1.0 (2.2)
No change
31 (18%)
−1.0 (2.3)
A little worse
12 (7%)
0.3 (3.6)
Minimally worse
15 (9%)
0.0 (3.6)
Much worse
7 (4%)
−0.5 (2.1)
Much worse
3 (2%)
−1.1 (2.9)
Very much worse
0
Very much worse
0
Presented as the mean change in OFF time (standard deviations). PGI-I: Patient-rated Global Impression of Improvement; CGI-I: Clinician-rated Global Impression of Improvement.
