TABLE 6.
Crossover Study Outcomes in Compliant Participants (n = 28)
| Varenicline LS, Mean (SE) | Placebo LS, Mean (SE) | Treatment Difference (95% CI) | p | |
|---|---|---|---|---|
| Gait speed–normal pace–no dual task, cm/s | 119.17 (1.54) | 122.06 (1.54) | −2.90 (−5.48, −0.31) | 0.03a |
| MDS-UPDRS III total | 33.54 (1.29) | 30.72 (1.27) | 2.82 (−0.18, 5.81) | 0.06 |
| Gait speed–normal pace–dual task minus gait speed–normal pace–no dual task | −6.56 (1.28) | −9.24 (1.27) | 2.68 (−0.14, 5.49) | 0.06 |
| Normal pace dual task cost | −5.78 (1.04) | −7.85 (1.04) | 2.07 (−0.18, 4.32) | 0.07 |
| Cadence–normal pace–no dual task | 109.69 (0.66) | 111.87 (0.66) | −2.17 (−3.87, −0.48) | 0.01a |
| Mean stride length–normal pace–no dual task | 130.02 (1.34) | 131.51 (1.33) | −1.49 (−3.39, 0.41) | 0.12 |
| Mean stride time–normal pace–no dual task | 1.10 (0.01) | 1.07 (0.01) | 0.02 (0.005, 0.04) | 0.02a |
| SAT | 0.71 (0.07) | 0.61 (0.07) | 0.09 (0.002, 0.18) | 0.05a |
Items shown are those with statistically significant differences in ITT analysis for comparison between ITT and compliant groups. All other items without statistically significant differences are between varenicline and placebo treatment periods in compliant population. Estimates (least squares or adjusted means and standard errors) and p values were obtained from a linear mixed model containing treatment sequence, treatment period, treatment group, and dependent-variable baseline value, with participant within treatment sequence as a random effect.
Statistically significant.
CI = confidence interval; ITT = intention-to-treat; LS = least squares; MDS-UPDRS III = Movement Disorder Society Unified Parkinson’s Disease Rating Scale, part III; SAT = sustained attention test; SE = standard error.