Abstract Details

This Phase 3 study showed that treatment with an optimized ND0612 regimen provided an additional 1.72h [95% CI: 1.08h, 2.36h] of ON-time without troublesome dyskinesia compared with immediate-release levodopa/carbidopa (IR-LD/CD; p<0.0001).

To evaluate the efficacy and safety of 24-hour subcutaneous levodopa/carbidopa infusion with investigational ND0612 for different subgroups of people with Parkinson’s disease (PwP) experiencing motor fluctuations.

Phase 3, double-blind, double-dummy, active-controlled trial (NCT04006210) comparing optimized ND0612 vs optimized IR-LD/CD. Subgroups were analyzed separately for the primary endpoint (ON-time without troublesome dyskinesia) using ANCOVA with additional fixed factors for the subgroup variable and interaction term between the treatment group, and subgroup variable. The influence of each subgroup factor was investigated by the interaction terms using Type III p-value combined for multiple imputation.

The adjusted mean [95% CI] treatment effect of ND0612 was overall homogeneous across the different analyzed subgroups, including age (1.75h [0.89, 2.62] vs.1.63h [0.67, 2.59] for <65 years [n=143] vs. ≥65 years [n=116]), sex (2.05h [0.98, 3.12] vs. 1.59h [0.78, 2.40] for female [n=94] vs. male [n=165]), BMI (2.07h [1.16, 2.98] vs. 1.36h [0.45, 2.27] for BMI median ≤25.7 [n=129] vs. >25.7 [n=130]), geographic region (1.49h [0.72, 2.26] vs. 2.21h [1.06, 3.36] for Europe/Israel [n=177] vs. USA [n=82]), and Baseline Good ON time (1.27h [0.36, 2.19] vs. 2.20h [1.30, 3.11] for baseline median of ≤12.1h [n=129] vs. >12.1h [n=129] Good ON). Treatment effects for subgroups categorized by oral optimized levodopa dose (<700mg, 700-1500mg, 1500-2000mg, > 2000mg) were 2.01h [0.24, 3.79], 1.73h [0.97, 2.49], 1.13h [-0.81, 3.08], 2.54h [-1.86, 6.95], respectively, with no significant difference between groups. No relevant differences in safety or tolerability were observed between any of the subgroups assessed.

The overall treatment effect was homogenous across different analyzed subgroups. Findings from these analyses support improved Good ON time, consistent with the overall effect of 1.72h.