Table 2.
Diary state (hours per day); | Placeboa | Gocovrib | Treatment difference | P-value |
---|---|---|---|---|
LS mean ± SE change from baseline | ||||
ON without (any) dyskinesiac | ||||
Week 2 | 1.2 ± 0.4 | 4.3 ± 0.4 | 3.2 ± 0.5 | < 0.0001 |
Week 8 | 1.8 ± 0.4 | 4.5 ± 0.4 | 2.7 ± 0.6 | < 0.0001 |
Week 12 | 1.7 ± 0.4 | 4.6 ± 0.4 | 2.9 ± 0.6 | < 0.0001 |
ON with dyskinesia | ||||
Week 2 | −1.2 ± 0.4 | −3.7 ± 0.4 | −2.6 ± 0.5 | < 0.0001 |
Week 8 | −2.1 ± 0.4 | −4.0 ± 0.4 | −1.9 ± 0.6 | 0.001 |
Week 12 | −2.2 ± 0.4 | −4.1 ± 0.4 | −1.9 ± 0.6 | 0.002 |
ON with non-troublesome dyskinesia | ||||
Week 2 | 0.4 ± 0.3 | −0.5 ± 0.3 | −0.9 ± 0.4 | 0.02 |
Week 8 | 0.1 ± 0.3 | −0.5 ± 0.3 | −0.6 ± 0.5 | 0.24 |
Week 12 | −0.3 ± 0.3 | −0.8 ± 0.3 | −0.6 ± 0.4 | 0.2 |
ON with troublesome dyskinesia | ||||
Week 2 | −1.4 ± 0.3 | −3.3 ± 0.3 | −1.8 ± 0.4 | < 0.0001 |
Week 8 | −2.1 ± 0.3 | −3.6 ± 0.3 | −1.5 ± 0.4 | 0.0001 |
Week 12 | −1.9 ± 0.3 | −3.3 ± 0.3 | −1.5 ± 0.4 | 0.0003 |
OFF | ||||
Week 2 | −0.2 ± 0.2 | −0.5 ± 0.2 | −0.3 ± 0.2 | 0.17 |
Week 8 | 0.2 ± 0.2 | −0.5 ± 0.2 | −0.7 ± 0.3 | 0.01 |
Week 12 | 0.4 ± 0.2 | −0.6 ± 0.2 | −1.0 ± 0.3 | 0.0006 |
Placebo sample size: Week 2, n = 94; Week 8, n = 87; and Week 12, n = 86.
Gocovri sample size: Week 2, n = 94; Week 8, n = 80; and Week 12 n = 79.
ON without (any) dyskinesia is defined as ON time with neither troublesome nor non-troublesome dyskinesia.