Table 2.
Secondary efficacy outcomes, changes from baseline to week 8
| LS Mean Treatment Difference vs. Placebo (95% CI) | |||
|---|---|---|---|
| Outcome Measure | 260 mg ADS‐5102 (n = 19) | 340 mg ADS‐5102 (n = 20) | 420 mg ADS‐5102 (n = 19) |
| ON time without troublesome dyskinesia, h | 3.3 (1.1, 5.5) p=0.004 | 3.0 (0.8, 5.2) p=0.008 | 2.7 (0.5, 5.0) p=0.018 |
| ON time with troublesome dyskinesia, h | −1.3 (−3.1, 0.6) p=0.169 | −1.8 (−3.6, 0.0) p=0.055 | −2.8 (−4.6, −0.9) p=0.003 |
| ON time with dyskinesia, total, h | −1.1 (−3.7, 1.5) p=0.408 | −2.1 (−4.8, 0.5) p=0.117 | −3.1 (−5.8, −0.5) p=0.021 |
| OFF time, h | −1.3 (−2.7, 0.1) p=0.074 | −0.9 (−2.3, 0.5) p=0.199 | 0.1 (−1.4, 1.5) p=0.934 |
| Sleep time, h | −0.8 (−1.8,0.2) p=0.099 | −0.4 (−1.4,0.5) p=0.367 | −0.3 (−1.2,0.7) p=0.573 |
| UDysRS, total objective score (parts III, IV) | −2.5 (−6.0, 0.9) p=0.147 | −5.2 (−8.7, −1.7) p=0.004 | −6.4 (−9.8, −2.9) p<0.001 |
| MDS‐UPDRS (part IV) | −0.7 (−2.9, 1.5) p=0.520 | −2.4 (−4.6, −0.3) p=0.026 | −3.4 (−5.6, −1.2) p=0.003 |
| MDS‐UPDRS (part IV, item 4.1) ‐Time spent with dyskinesia | −0.2 (−0.8, 0.5) p=0.630 | −0.6 (−1.2, 0.1) p=0.100 | −0.6 (−1.3, 0.0) p=0.057 |
| MDS‐UPDRS, (part IV, item 4.2) ‐Functional impact of dyskinesia | −0.8 (−1.4, −0.2) p=0.014 | −1.0 (−1.6, −0.4) p=0.002 | −1.3 (−2.0, −0.7) p<0.001 |
| MDS‐UPDRS (parts I, II, III, combined) | 1.2 (−7.7, 10.1) p=0.786 | −2.2 (−11.2, 6.9) p=0.636 | 1.7 (−7.2, 10.6) p=0.705 |
| Fatigue Severity Score | 0.2 (−0.6, 1.0) p=0.630 | −0.3 (−1.1, 0.5) p=0.431 | 0.3 (−0.5, 1.0) p=0.522 |
| PDQ‐39 (summary index score) | −0.3 (−8.7, 8.0) p=0.942 | −3.4 (−11.5, 4.7) p=0.406 | 2.2 (−5.9, 10.3) p=0.590 |
| Outcome Measure | Placebo (n = 22) | 260 mg ADS‐5102 (n = 19) | 340 mg ADS‐5102 (n = 20) | 420 mg ADS‐5102 (n = 19) | |
|---|---|---|---|---|---|
| CGI‐C, n (%) | Marked improvement | 1 (4.5) | 2 (10.5) | 7 (35.0) | 4 (21.1) |
| Moderate improvement | 6 (27.3) | 8 (42.1) | 8 (40.0) | 6 (31.6) | |
| Minimal improvement | 4 (18.2) | 5 (26.3) | 1 (5.0) | 5 (26.3) | |
| No change | 10 (45.5) | 3 (15.8) | 4 (20.0) | 2 (10.5) | |
| Minimal worsening | 1 (4.5) | 1 (5.3) | 0 | 0 | |
| Moderate worsening | 0 | 0 | 0 | 2 (10.5) | |
| Marked worsening | 0 | 0 | 0 | 0 | |
| P‐valuea | N/A | 0.1042 | 0.0036 | 0.2158 | |
a
The P‐value was determined using the Cochran‐Mantel‐Haenszel mean score test (using equally spaced scores)
Abbreviations: LS, least square; CI, confidence interval; UDysRS, Unified Dyskinesia Rating Scale; MDS‐UPDRS, Movement Disorder Society Unified Parkinson's Disease Rating Scale; PDQ‐39, Parkinson's Disease Questionnaire; CGI‐C, Clinician Global Impression of Change.