Table 4.
Efficacy Outcomes (UPDRS and PDQ-39) by Baseline Dyskinesia Status (Change from Baseline to EOS) (Randomized Population)
| No Dyskinesia | Non-Troublesome Dyskinesia Only | Troublesome Dyskinesia | ||||||||||
| Endpoint | CD-LD ER | CD-LD IR | LS Mean Difference | p-value | CD-LD ER | CD-LD IR | LS Mean Difference | p-value | CD-LD ER | CD-LD IR | LS Mean Difference | p-value |
| (N = 91) | (N = 92) | (N = 66) | (N = 65) | (N = 44) | (N = 35) | |||||||
| UPDRS | ||||||||||||
| Parts II and III | –6.15 | –4.23 | –1.92 | 0.1587 | –4.54 | –1.24 | –3.31 | 0.0576 | –4.56 | 2.29 | –6.85 | 0.0191 |
| Parts I, II, and III | –6.40 | –4.14 | –2.27 | 0.1157 | –4.84 | –1.29 | –3.55 | 0.0495 | –4.83 | 2.42 | –7.25 | 0.0195 |
| Total | –6.69 | –4.64 | –2.05 | 0.1811 | –5.69 | –1.37 | –4.32 | 0.0262 | –4.90 | 2.03 | –6.94 | 0.0320 |
| Part I | –0.25 | 0.10 | –0.35 | 0.0636 | –0.29 | –0.04 | –0.25 | 0.3031 | –0.37 | 0.11 | –0.48 | 0.2793 |
| Part II: on state | –1.64 | –0.55 | –1.10 | 0.0423 | –0.69 | –0.73 | 0.04 | 0.9625 | –1.00 | 0.92 | –1.92 | 0.1068 |
| Part II: off state | –1.70 | –0.64 | –1.06 | 0.0803 | –0.50 | –0.52 | 0.01 | 0.9880 | –0.33 | 0.57 | –0.91 | 0.4547 |
| Part III | –4.42 | –3.57 | –0.85 | 0.4160 | –3.75 | –0.37 | –3.38 | 0.0047 | –3.52 | 1.24 | –4.76 | 0.0299 |
| Part IV | –0.27 | –0.36 | 0.09 | 0.7729 | –0.84 | –0.28 | –0.56 | 0.1718 | –0.12 | –0.38 | 0.26 | 0.6168 |
| PDQ-39 | ||||||||||||
| Total | –5.76 | –2.00 | –3.76 | 0.0192 | –2.33 | –1.74 | –0.59 | 0.8063 | –2.89 | –2.31 | –0.58 | 0.8428 |
| Mobility | –7.01 | –1.45 | –5.56 | 0.0058 | –4.10 | –1.53 | –2.56 | 0.4532 | –2.67 | –2.64 | –0.04 | 0.9937 |
| Activities of daily living | –9.47 | –3.42 | –6.05 | 0.0038 | –2.07 | –3.77 | 1.69 | 0.6165 | –0.34 | –2.38 | 2.04 | 0.6593 |
| Emotional wellbeing | –3.30 | 0.22 | –3.53 | 0.1420 | –3.40 | –1.77 | –1.62 | 0.5268 | –2.90 | –6.49 | 3.60 | 0.2868 |
| Stigma | –8.24 | –7.36 | –0.88 | 0.7000 | –3.19 | –4.31 | 1.12 | 0.7185 | –5.48 | –4.26 | –1.22 | 0.7700 |
| Social support | –1.17 | 0.65 | –1.82 | 0.4399 | 1.00 | 0.84 | 0.16 | 0.9565 | –5.73 | –3.38 | –2.35 | 0.5165 |
| Cognition | –0.93 | 0.64 | –1.58 | 0.4119 | –1.03 | –0.72 | –0.31 | 0.8933 | –4.43 | 1.61 | –6.04 | 0.1641 |
| Communication | –3.39 | –1.03 | –2.36 | 0.3156 | –3.83 | –0.68 | –3.15 | 0.3084 | –3.12 | 2.39 | –5.51 | 0.2481 |
| Bodily discomfort | –6.27 | –2.96 | –3.31 | 0.1760 | –2.12 | –2.75 | 0.63 | 0.8601 | –7.12 | 3.38 | –10.50 | 0.0906 |
Note: LS Means and p-value from an ANCOVA model with change from baseline at EOS as outcome, treatment and pooled site as fixed effects and baseline value as covariate, unless otherwise specified. CD-LD ER, carbidopa-levodopa extended release; CD-LD IR, carbidopa-levodopa immediate release; EOS, End of Study; LS, least squares; PDQ-39, 39-Item Parkinson’s Disease Questionnaire; UPDRS, Unified Parkinson’s Disease Rating Scale.