Objective: Describe 1-year efficacy outcomes from the ongoing open-label extension (OLE) phase of the BouNDless study (NCT04006210) of subcutaneous levodopa/carbidopa infusion (ND0612) for fluctuating PD patients.

Background: It has been previously reported that open-label treatment with ND0612 was associated with a sustained ≥2-hour increase in daily ON-time without troublesome dyskinesia (Good ON) and a reduction in OFF-time versus baseline [1]. The double-blind phase of the BouNDless study demonstrated that treatment with investigational ND0612 provided patients an additional 1.72h of Good ON-time compared with immediate-release levodopa/carbidopa (IR-LD/CD) (p<0.0001) [2].

Method: Patients who completed the double-blind phase of the BouNDless study were eligible to enter the ongoing OLE phase (up to 54 months). Patients received ND0612 and all anti-PD medications (including ND0612) were adjusted according to individual response. This analysis was performed at 6 months and 1 year post enrollment of the last patient who entered the OLE. Changes in OFF-time, ON-time without-, with non-troublesome-, and with troublesome-dyskinesia, measured from ND0612 initiation in the run-in phase of the pivotal study [1] to Months 6 and 12 of the OLE phase, were normalized to 16h and analyzed without imputation. Changes in ON-time with troublesome dyskinesia were analyzed for the subgroup of patients who had ≥1h troublesome dyskinesia at treatment onset.

Results: Of 232 participants who entered the OLE phase (n=113 previously randomized to ND0612, n=119 previously randomized to IR-LD/CD), 167 (72%) completed 1 year of ND0612 treatment in the OLE phase. By Month 6, patients had a mean±SE change of –2.2±0.2h in OFF-time and an +2.4±0.2h in Good ON-time (+2.7±0.2h in ON-time without dyskinesia and –0.3±0.2 in ON-time with non-troublesome dyskinesia). Efficacy benefits were sustained at Month 12 with a change of –2.1±0.2h in OFF-time and +2.2±0.2h in Good ON-time (+2.3±0.3h in ON-time without dyskinesia and –0.2±0.2h in ON-time with non-troublesome dyskinesia). Patients who had ≥1h of ON-time with troublesome dyskinesia at ND0612 initiation (n=45) showed a change of –1.2±0.3h at Month 6 and –1.5±0.3h at Month 12.

Conclusion: Results corroborate previously published data [1] on the long-term efficacy of ND0612 for PD patients experiencing motor fluctuations.

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 2021; 36(11):2687-2692.
[2] 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/long-term-efficacy-of-24-hour-subcutaneous-levodopa-carbidopa-infusion-nd0612-for-motor-fluctuations-in-parkinsons-disease/