Objective: To report long-term safety and tolerability data from the ongoing BeyoND study (NCT02726386) for patients who continued treatment past the one-year primary endpoint.

Background: ND0612 is in development as a continuous, subcutaneous levodopa/carbidopa (LD/CD) delivery system for the treatment of patients with PD experiencing motor fluctuations. Primary safety data from the BeyoND study showed that subcutaneous LD/CD infusion with ND0612 is generally safe up to one year of treatment [1]. The study has been extended to 102 months, and we report accumulating safety and tolerability data for the subgroup of patients who continued treatment past the one-year primary endpoint.

Method: Patients with PD (aged ≥30 years) taking ≥4 LD doses/day and ≥1 other PD medication and experiencing ≥2 hours of OFF time/day were eligible for this ongoing study. Patients received open-label ND0612 for a regimen of either 16-hours/day or 24-hours/day.

Results: Of the 114 patients who continued into the extension period, 111 have completed ≥2 years treatment, 76 have completed ≥3 years. As of December 2021, 58 patients were still in the study, with a treatment duration of up to 5.1 years. Nineteen participants (16.7%) have discontinued due to a TEAE, including four who withdrew due to infusion site reactions (ISRs). Across 5 years of follow-up, 91 (79.8%) patients had ≥1 drug-related treatment-emergent adverse event (TEAE). The most frequent TEAEs were ISRs (including nodules [46.5%] and hematoma [35.1%]), which were generally reversible and manageable. Overall, 36 (31.6%) patients had infusion site infection, of which 8 patients reported serious infections (all 8 patients continued with treatment and the infection resolved). Nausea was the only drug-related systemic TEAE with incidence over 5% (7.0%).

Conclusion: Continuing beyond 12-months, ND0612 infusion was safe, with generally mild to moderate local TEAEs that were reversible and manageable. Systemic safety was typical for PD patients treated with LD/CD, enabling long-term tolerability and adherence with ND0612, including some patients in their sixth year of treatment.

References: [1] Poewe W, Stocchi F, Arkadir D, et al. Subcutaneous Levodopa Infusion for Parkinson’s disease: One-Year Data from the Open-Label BeyoND study. Mov Disord 36(11):2687-2692.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-safety-of-continuous-levodopa-carbidopa-infusion-with-nd0612-data-from-patients-who-continued-past-one-year-in-the-beyond-study/