To evaluate the efficacy of subcutaneous levodopa/carbidopa infusion with ND0612 in reducing OFF time in people with Parkinson’s disease (PwP) experiencing motor fluctuations.

We have previously reported that one year treatment with ND0612 infusion was generally safe and well-tolerated. Adjusted mean daily ‘Good ON’ time (sum of ON time without dyskinesia + ON time with non-troublesome dyskinesia) increased from baseline by 2.3 hours at Month 3 and was maintained for at least 12 months (Poewe et al., Mov Disord 2021; 36: 2687-2692).

The BeyoND study is an ongoing open-label study (NCT02726386) of ND0612 treatment conducted in PD patients (n=214) with Hoehn & Yahr score of ≤3 during ON experiencing ≥2 hours daily OFF-time. In these analyses of daily OFF time (patient home diaries), a responder was conservatively defined as a patient who achieved ≥50% reduction from baseline in adjusted mean daily OFF time.

Using the last observation carried forward, 44.0% patients were classified as treatment responders, and this level of response was maintained over the 12 months of follow-up. Moreover, 63.5% of patients achieved a >25% reduction in OFF time from baseline and 26.9% of patients achieved a >75% reduction in OFF time. Additionally, 12.8% of patients achieved a 100% reduction in OFF time reduction. Using only observed cases (i.e., not LOCF), the percentage of ND0612 treatment responders increased from 44.0% at Month 1 (N=150) to 53.3% at Month 6 (N=107), and 56.7% at Month 12 (N=90).

This open-label study provides preliminary support for the 12-month efficacy of treatment with ND0612 in reducing OFF time in PwP experiencing motor fluctuations.