SC LEVODOPA PD
(2026)Objective
To assess whether continuous subcutaneous infusion of levodopa/carbidopa (ND0612) or foslevodopa/foscarbidopa safely reduces daily OFF-time and improves quality of life compared to oral levodopa/carbidopa in Parkinson's disease patients.
Study Summary
• ND0612 reduced OFF-time by 1.42 h/day; foslevodopa/foscarbidopa reduced OFF-time by 2.76 h/day — both statistically significant
• PDQ-39 quality of life improved (p = 0.0003) and PDSS-2 sleep score improved (p = 0.02), though QoL improvement was statistically but not clinically significant
• Treatment-emergent adverse events were increased (p = 0.04), predominantly infusion site reactions
Intervention
Continuous subcutaneous infusion of levodopa/carbidopa (ND0612) or foslevodopa/foscarbidopa via wearable pump, administered over 14–24 hours per day, with or without supplementary oral levodopa depending on formulation
Inclusion Criteria
Randomized and non-randomized clinical trials of any duration comparing subcutaneous levodopa or foslevodopa infusion to oral levodopa/carbidopa in Parkinson's disease patients of any age or gender, with comparative data on at least one specified outcome
Study Design
Arms: Subcutaneous ND0612 (n=407) or foslevodopa/foscarbidopa (n=318) vs. oral levodopa/carbidopa with sham infusion (control, across 7 studies)
Patients per Arm: 725 total received subcutaneous infusions: ND0612 n=407; foslevodopa/foscarbidopa n=318
Outcome
• PDQ-39 QoL improved (p = 0.0003); PDSS-2 sleep improved (p = 0.02) — both moderate-quality evidence
• Increased treatment-emergent adverse events with subcutaneous infusion (p = 0.04), predominantly infusion site-related