Title: ND0612 Infusion Dramatically Reduces OFF-time and Improves Quality of Life in Parkinson’s Disease: A Meta-analysis of Randomized Trials (P8-17.009)
Authors: Shenney Lin, Jamir Pitton Rissardo, Omar Elmandouh, Ana Leticia Fornari Caprara, and Ian M. Walker
Conference: 2026 AAN, Chicago, IL
Objective
To evaluate the efficacy of ND0612 compared with placebo or current oral therapy in patients with Parkinson’s disease (PD).
Background
Long-term oral levodopa, while an effective therapy for PD, often causes motor fluctuations with increasing OFF time and dyskinesias due to pulsatile drug levels. ND0612, a continuous subcutaneous levodopa/carbidopa infusion, aims to provide stable plasma levels and reduce OFF time.
Design/Methods
A systematic review of PubMed and meta-analysis of randomized controlled trials comparing ND0612 with placebo or current oral regimens was conducted. Outcomes included OFF-time (hours/day), ON-time without troublesome dyskinesia, PDQ-39, PDSS, and UPDRS-III. Standardized mean differences (SMD) or mean differences (MD) with 95% confidence intervals (CI) were pooled using inverse variance methods under fixed and random-effects models.
Results
Three trials (n = 327). OFF time: ND0612 significantly reduced OFF time compared with comparators (SMD = –0.55; p < 0.0001). ON time without dyskinesia: Increased with ND0612 (SMD = 0.54; p = 0.0047). Quality of life (PDQ-39): Improved by –2.89 points (p = 0.0049). Sleep quality (PDSS): Some benefit seen under fixed-effect model (MD = –2.11; p = 0.021), but not consistent with random-effects. Motor function (UPDRS-III): No significant change (MD = 1.41; p = 0.687). Subgroup analysis: No significant differences between placebo and current therapy comparators..
Conclusions
ND0612 significantly reduces OFF time and increases ON time without dyskinesia, improving quality of life in Parkinson’s disease patients with motor fluctuations. Effects were consistent across comparator types. Improvements in sleep and motor scores were less certain and require further study. ND0612 is a promising non-surgical option for continuous dopaminergic delivery.
Citation
Lin S, Rissardo JP, Elmandouh O, Caprara AL, Walker IM. ND0612 Infusion Dramatically Reduces OFF-time and Improves Quality of Life in Parkinson’s Disease: A Meta-analysis of Randomized Trials (P8-17.009). Neurology 2026;106(11_suppl):1166. doi: 10.1212/WNL.0000000000215020.
Figure 1. Forest plot shows ND0612 significantly reduces OFF-time versus placebo or current therapy, with consistent effects across comparator subgroups and no heterogeneity.
Figure 2. Forest plot shows ND0612 significantly improves quality of life compared to controls, with consistent findings and minimal heterogeneity.
Figure 3. Forest plot shows no significant improvement in motor scores with ND0612, with moderate heterogeneity across studies.