Objective: Evaluate the effect of investigational ND0612 infusion on the daily number of, duration of, and transitions between PD motor states, as assessed by home diaries.

Background: Primary efficacy analysis (ON-time without troublesome dyskinesia) demonstrated superiority of ND0612 over immediate-release levodopa/carbidopa (IR-LD/CD), with a significant difference of 1.72h (p<0.0001).

Method: Post hoc analysis of diary data from the BouNDless study (NCT04006210 [1]). The number and duration of episodes spent in the OFF state, ON without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia (collected on the last day prior to each visit) were analyzed descriptively. Episodes were defined as time spent in a PD-diary state before transitioning to any other state. The total number of transitions between any motor state were analyzed by baseline-adjusted Poisson Regression.

Results: Motor state characteristics were balanced between ND0612 and IR-LD/CD groups prior to ND0612 initiation (ie, in the run-in phase). At the end of the double-blind phase, patients in the ND0612 vs IR-LD/CD group experienced an average of 2.4 vs 3.3 OFF episodes per day, with a total daily OFF-duration of 3.8h vs 5.2h. Participants (ND0612 vs IR-LD/CD) experienced 2.7 vs 3.1 episodes of ON without dyskinesia (total duration of 9.4h vs 7.4h); 1.2 vs 1.4 episodes of ON with non-troublesome dyskinesia (total duration of 2.2h vs 2.7h); and 0.3 vs 0.5 episodes of ON with troublesome dyskinesia (total duration of 0.4h vs 0.7h). The mean number of daily transitions between motor states was lower with ND0612 compared to IR-LD/CD treatment (5.7 vs 7.3, p<0.0001).

Conclusion: Treatment with ND0612, versus IR-LD/CD, led to more stable motor control, as demonstrated by fewer daily transitions between motor states, and by more time in the ON state without any dyskinesia.

References: [1] Espay et al. Safety and efficacy of continuous subcutaneous levodopa–carbidopa infusion (ND0612) for Parkinson’s disease with motor fluctuations (BouNDless): a phase 3, randomised, double-blind, double-dummy, multicentre trial. Lancet Neurol; 2024. In press.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-24-hour-subcutaneous-levodopa-carbidopa-infusion-nd0612-on-motor-state-transitions-throughout-the-day/