Table 3.
Change of subjective sleep scores between the zonisamide treatment and placebo groups in the full analysis set (FAS).
| zonisamide treatment | placebo | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| baseline | 14 days | 28 days | quantity of alteration (14 days) | p* | quantity of alteration (28 days) | p* | baseline | 14 days | 28 days | quantity of alteration (14 days) | p* | quantity of alteration (28 days) | p* | |
| PDSS-2 | 22.9 ± 8.3 (n = 33) a | 21.7 ± 8.7 (n = 32) a | 22.0 ± 7.8 (n = 33) a | −1.2 ± 6.0 (n = 32) b |
0.263 | −0.8 ± 6.8 (n = 33) b |
0.478 | 23.2 ± 8.6 (n = 31) a | 23.3 ± 10.0 (n = 34) a | 19.7 ± 7.6 (n = 33) a | −0.1 ± 6.6 (n = 31) b |
0.914 | −3.7 ± 6.7 (n = 31) b |
0.005 |
| Pittsburg Sleep Questionnaire | 8.5 ± 4.0 (n = 32) a | 8.3 ± 3.8 (n = 32) a | 8.2 ± 3.7 (n = 33) a | −0.3 ± 2.5 (n = 32) b |
0.526 | −0.4 ± 2.7 (n = 32) b |
0.436 | 8.8 ± 3.3 (n = 32) a | 8.9 ± 3.9 (n = 32) a | 8.5 ± 3.6 (n = 31) a | 0 ± 2.9 (n = 31) b |
0.951 | −0.3 ± 2.5 (n = 30) b |
0.513 |
| RBDSQ | 5.7 ± 3.1 (n = 32) a | 4.4 ± 2.5 (n = 32) a | 5.3 ± 3.3 (n = 31) a | −1.2 ± 3.1 (n = 31) b |
0.035* | −0.4 ± 2.2 (n = 30) b |
0.295 | 5.6 ± 3.1 (n = 31) a | 5.2 ± 2.8 (n = 31) a | 4.5 ± 2.8 (n = 32) a | −0.4 ± 2.2 (n = 28) b |
0.357 | −1.1 ± 2.6 (n = 30) b |
0.032* |
PDSS-2:Parkinson’s Disease Sleep Scale-2 Japanese version, RBDSQ: Sleep Behavior Disorder Screening questionnaire Japanese version, data are reported as mean (standard deviation), *p < 0.05, * comparison of quantity of alteration in each group between baseline and 14 or 28 days, a; total number of respondents to all questions at baseline, 14 days, and 28 days following the intervention. b: the quantity of alteration of three subjective sleep scores was analyzed patients who had both pre- and post-intervention data.