Table 2

Synopsis of primary and secondary end points for the intent to treat population (last observation carried forward technique): absolute changes from baseline to end of maintenance

Pramipexole (n=44)Placebo (n=39)Difference between groups (95% CI)Difference in mean relative changes (%)
Values are mean (SD) or n (%) for pramipexole and placebo group; differences in the mean absolute changes between groups (mean and 95% confidence intervals (95% CIs); and differences in mean relative changes between groups ((%)); p values are given for the differences in the mean absolute changes (controlled for differences between study centres); NA, not applicable.
Tremor scores (UPDRS):
    Tremor score−5.8 (5)−1.5 (3.2)−4.4 (−6.2 to −2.5)−34.7p<0.0001
        Item 16−0.7 (0.9)−0.2 (0.7)−0.6 (−0.9 to −0.2)−21.5p<0.01
        Item 20−3.6 (3.3)−1.0 (2.2)−2.6 (−3.8 to −1.4)−37.9p<0.0001
        Item 21−1.5 (1.6)−0.3 (1.1)−1.2 (−1.8 to −0.6)−35.6p<0.0001
UPDRS scores:
    UPDRS II/III (sum score)−18.8 (13.9)−3.8 (8.3)−15 (−20 to −10)−30.9p<0.0001
    UPDRS II (average “on”-”off”)−3.6 (3.8)−0.1 (2.6)−3.5 (−4.9 to −2.0)−25.2p<0.0001
    UPDRS III (“on”)−15.2 (11.6)−3.7 (6.8)−11.5 (−15.7 to −7.4)−34.1p<0.0001
Patient's diary:
    Daily living−4.7 (8.6)3.4 (8.0)−8.1 (−11.7 to −4.5)−43.4p<0.0001
    Severity−1.6 (2.1)0.6 (2.2)−2.2 (−3.1 to −1.3)−39.5p<0.0001
Long term EMG:
    Tremor occurrence (%)−19.3 (14.8)−4.1 (13.2)−15.2 (−21.4 to −9.0)−45.7p<0.0001
Global assessment (patients with improvement (%)):
    Investigator's assessment56.812.844.0 (26.1 to 61.9)NAp<0.0001
    Patient's assessment56.817.938.9 (20.0 to 57.7)NAp<0.0001