Table 3.
Effect of levodopa on disease progression |
Scenario | Placebo difference from baseline at 42 weeksa |
Levodopa treatment difference from placebo at 42 weeksa |
||
---|---|---|---|---|---|
Low | Medium | High | |||
Observed ELLDOPAb | 7.8±1.1 | 5.9±0.7 | 5.9±0.8 | 9.2±0.9 | |
Protective | Predicted effect site Concentration Washoutc | 9.9±1.0 | 3.8±1.4 | 5.9±1.3 | 8.4±1.3 |
Toxic | Predicted effect site Concentration Washoutc | 10.0±1.0 | 1.0±1.3 | 0.4±1.5 | −1.4±1.5d |
Predictions assume levodopa has symptomatic and protective actions with slow symptomatic washout. From [4]
Difference between 0 and 42 weeks
Mean ± SE calculated from treatment mean difference from placebo and placebo SD and number of patients in active dose arms
Bootstrap mean ± SD of 100 simulated trial replications. The SD is equivalent to the SE for placebo change from baseline
Negative value represents an increase in total UPDRS