Table 6.
Change in UPDRS part III score from baseline (SAS)
| PLA-DON10 | DON5-DON10 | DON10-DON10 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Evaluation points | n | Score | Change a | P value b | n | Score | Change a | P value b | n | Score | Change a | P value b |
| Screening | 46 | 21.4 ± 12.5 | - | - | 47 | 20.6 ± 11.9 | - | - | 49 | 19.3 ± 12.3 | - | - |
| Week 12 | 37 | 20.1 ± 13.2 | −1.1 ± 4.7 | P = 0.184 | 32 | 17.0 ± 11.9 | −3.0 ± 7.6 | P = 0.032* | 44 | 19.6 ± 13.2 | 0.3 ± 5.3 | P = 0.711 |
| Week 24 | 36 | 19.1 ± 12.0 | −1.8 ± 4.6 | P = 0.023* | 29 | 17.0 ± 11.5 | −3.5 ± 8.3 | P = 0.029* | 43 | 19.4 ± 14.7 | −0.2 ± 8.6 | P = 0.873 |
| Week 40 | 33 | 19.9 ± 13.8 | −2.0 ± 6.9 | P = 0.106 | 25 | 16.1 ± 12.6 | −5.0 ± 9.5 | P = 0.014* | 42 | 20.6 ± 15.7 | 0.6 ± 10.0 | P = 0.680 |
| Week 52 | 34 | 20.6 ± 16.0 | −0.7 ± 9.4 | P = 0.677 | 26 | 16.1 ± 13.2 | −4.8 ± 10.2 | P = 0.023* | 40 | 21.1 ± 16.2 | 0.9 ± 10.0 | P = 0.584 |
| Week 52 (LOCF) | 42 | 20.6 ± 14.9 | −1.1 ± 8.9. | P = 0.431 | 44 | 19.2 ± 13.9 | −1.8 ± 9.6 | P = 0.211 | 48 | 20.1 ± 15.5 | 1.0 ± 9.4 | P = 0.474 |
UPDRS, Unified Parkinson’s Disease Rating Scale; SAS, safety analysis set; LOCF, last observation carried forward.
Bolds indicate the period when the patients in each group took placebo.
Italics indicate the period when the PLA-DON10 and DON5-DON10 patients took 5 mg study drug (the PLA-DON10 and DON5-DON10 groups took 3 mg from Week 16 to 18 and Week 0 to 2, respectively).
The rest indicates the period when the patients took 10 mg (the DON10-DON10 group took 3 mg from Weeks 0 to 2, and 5 mg from Weeks 2 to 6).
aA positive value of the UPDRS part III change indicates deterioration in motor function.
bStudent paired t test.
*P < 0.05.