Minimal Clinically Important Difference in Parkinson’s Disease as Assessed in Pivotal Trials of Pramipexole Extended Release
Table 2
Mean changes in UPDRS II, III, and II+III scores according to PGI-I and CGI-I ratings by treatment group in the advanced PD study.
PGI-I
(%)
UPDR II
UPDRS III
UPDRS II+III
CGI-I
(%)
UPDRS II
UPDRS III
UPDRS II+III
Pramipexole ER
Very much better
9 (6%)
−3.7 (2.5)
−12.7 (5.5)
−16.4 (7.2)
Very much improved
9 (6%)
−4.3 (2.5)
−13.3 (6.6)
−17.7 (8.8)
Much better
51 (32%)
−4.6 (4.3)
−11.2 (12.7)
−15.8 (15.9)
Much improved
69 (43%)
−4.3 (4.4)
−11.2 (11.3)
−15.5 (14.4)
A little better
66 (41%)
−2.8 (3.8)
−8.2 (8.8)
−11.1 (11.2)
Minimally improved
51 (32%)
−2.0 (3.9)
−7.7 (9.3)
−9.7 (11.9)
No change
20 (12%)
−2.5 (4.0)
−6.8 (9.8)
−9.3 (12.5)
No change
22 (14%)
−3.3 (3.6)
−7.8 (6.6)
−11.1 (7.9)
A little worse
13 (8%)
−0.9 (4.4)
−6.9 (6.4)
−7.8 (8.2)
Minimally worse
7 (4%)
−0.5 (2.7)
1.6 (9.7)
1.1 (10.2)
Much worse
1 (0.6%)
−1.0
6.0
5.0
Much worse
2 (1%)
0.3 (6.7)
−1.0 (0.0)
−0.8 (6.7)
Very much worse
1 (0.6%)
5.0
−1.0
4.0
Very much worse
0
Pramipexole IR
Very much better
10 (6%)
−6.3 (3.5)
−16.9 (12.9)
−23.2 (13.9)
Very much improved
11 (7%)
−5.4 (3.4)
−14.5 (7.1)
−20.0 (6.8)
Much better
66 (38%)
−4.9 (4.2)
−11.9 (9.9)
−16.8 (12.0)
Much improved
77 (46%)
−5.2 (4.3)
−12.9 (10.4)
−18.0 (12.6)
A little better
55 (32%)
−3.3 (4.1)
−9.5 (9.8)
−12.8 (12.9)
Minimally improved
55 (33%)
−3.0 (3.5)
−8.4 (9.0)
−11.3 (11.4)
No change
27 (16%)
−34.1 (4.2)
−6.0 (6.4)
−9.2 (8.6)
No change
19 (11%)
−2.5 (4.0)
−2.8 (7.4)
−5.3 (9.7)
A little worse
10 (6%)
−2.0 (2.4)
−3.2 (10.4)
−5.2 (10.9)
Minimally worse
4 (2%)
−0.6 (5.0)
−6.0 (3.6)
−6.6 (8.0)
Much worse
4 (2%)
0.1 (6.0)
1.8 (10.1)
1.9 (15.8)
Much worse
3 (2%)
−0.5 (7.1)
2.3 (9.3)
1.8 (16.1)
Very much worse
0
Very much worse
0
Placebo
Very much better
3 (2%)
−8.3 (8.8)
−11.0 (9.5)
−19.3 (18.3)
Very much improved
6 (4%)
−6.4 (6.3)
−9.5 (6.8)
−15.9 (13.1)
Much better
44 (26%)
−4.0 (5.8)
−8.9 (13.8)
−12.9 (18.6)
Much improved
50 (29%)
−3.8 (5.4)
−9.8 (12.1)
−13.6 (16.3)
A little better
65 (37%)
−1.9 (3.6)
−3.8 (7.2)
−5.6 (8.6)
Minimally improved
66 (39%)
−1.8 (3.7)
−3.8 (9.0)
−5.7 (10.8)
No change
43 (25%)
−1.0 (3.9)
−3.0 (6.7)
−4.0 (9.0)
No change
31 (18%)
−1.1 (4.7)
−1.0 (6.0)
−2.1 (7.9)
A little worse
12 (7%)
0.1 (4.5)
−1.3 (13.5)
−1.1 (15.6)
Minimally worse
15 (9%)
0.0 (3.3)
0.9 (6.2)
1.0 (7.9)
Much worse
7 (4%)
0.1 (5.6)
−1.1 (3.9)
−1.1 (8.5)
Much worse
3 (2%)
5.3 (4.0)
3.0 (4.4)
8.3 (8.3)
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.
