Efficacy data assessed by changes in “on/off” time and total daily levodopa dose and by IGAs of efficacy at the primary endpoint
| Treatment group | |||
|---|---|---|---|
| Placebo (n=58) | Tolcapone | ||
| 100 mg tid (n=60) | 200 mg tid (n=59) | ||
| “On”time (% of day): | |||
| Baseline | 53.4 (2.8) | 50.8 (2.5) | 52.4 (2.5) |
| Month 3 | 52.6 (3.6) | 62.0 (3.3) | 63.3 (3.3) |
| Change | −0.7 (2.8) | 10.8 (2.6)** | 10.8 (2.6)** |
| “Off”time (% of day): | |||
| Baseline | 37.8 (2.4) | 40.3 (2.1) | 37.4 (2.2) |
| Month 3 | 33.5 (3.0) | 27.0 (2.7) | 27.7 (2.7) |
| Change | −4.2 (2.3) | −12.7 (2.1)2-150 | −9.8 (2.1) |
| Total daily levodopa dose (mg): | |||
| Baseline | 660.5 (46.6) | 667.5 (41.5) | 675.8 (42.4) |
| Month 3 | 633.2 (43.2) | 558.4 (38.5) | 551.2 (39.3) |
| Change | −28.9 (26.2) | −108.9 (23.4)2-150 | −122.2 (23.9)** |
| IGA of severity of Parkinson’s disease (patients n (%)): | |||
| Improvement | 15 (29) | 40 (75)** | 40 (73)** |
| No improvement | 36 (71) | 13 (25) | 15 (27) |
| IGA of the “wearing off” phenomenon (patients n (%)): | |||
| Improvement | 19 (37) | 39 (74)** | 41 (75)** |
| No improvement | 32 (63) | 14 (26) | 14 (25) |
| IGA of overall efficacy (patients n (%)): | |||
| Improvement | 19 (37) | 37 (70)** | 43 (78)** |
| No improvement | 32 (63) | 16 (30) | 12 (22) |
↵2-150 P < 0.05; ** P < 0.01 v placebo. Data are means (SEM) for “on” and “off” time and means (SD) for levodopa dosage.
IGA=investigator’s global assessment.