Objective: To evaluate the efficacy, safety & tolerability of continuous subcutaneous infusion regimens of ND0612H.

Background: L-dopa remains the most effective PD medication, however oral treatment is associated with the development of motor complications that limit its clinical utility. Evidence indicates that continuous L-dopa/carbidopa (LD/CD) administration is associated with reduced motor complications, but the current infusion systems (eg. Duodopa) require invasive surgical procedures with associated safety risks. ND0612 is a proprietary liquid solution of LD/CD that can be delivered continuously SC. Preliminary studies indicate that this approach provides stable plasma levodopa PK and reduced OFF time without significant AEs. This study aims to evaluate the effect of ND0612H as well as to compare continuous 24h infusion with continuous 16h daytime dosing.

Methods: This is a rater-blind, multicenter, parallel-group, randomized clinical study in fluctuating PD patients. All subjects will undergo 1 day of standard oral LD/CD treatment followed by randomization to 2 days of treatment with continuous ND0612H SC infusion administered for 24h (total LD/CD dose of 720/90 mg) or infusion during the waking day (total LD/CD dose of 537.6–614.4/67.2-76.8 mg infused over ∼16h + supplemental dose of oral LD/CD [150/15 mg] in the morning). Subjects will then continue on the assigned regimen and return for assessment on Day 28. Efficacy is assessed on Days 2, 3 and 28 and includes: assessment of motor states (time to full ON in the mornings, ON with and without dyskinesia and OFF time assessed by a blinded rater), UPDRS subscores, clinical global impression, Parkinson’s disease Sleep Scale and PDQ-39. Safety/tolerability evaluations include AE reporting, assessment of infusion sites, nighttime sleep, daytime sleepiness & impulse control tolerability.

Results: A recruitment of 36 subjects (18 per arm) from 10 study sites is planned.

Conclusions: We are developing a continuous SC levodopa delivery system (ND0612H) as a treatment for motor fluctuations in patients with advanced PD that avoids potentially serious side effects associated with surgical interventions. In the present study we compare continuous infusion round the clock with infusion during the waking day with a morning oral bolus.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-randomized-controlled-clinical-study-to-evaluate-efficacy-safety-and-tolerability-of-sc-l-dopacarbidopa-nd0612h-infusion-regimens-in-fluctuating-pd-patients/