Enrollment characteristics for patients entering a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612

Document Type

Conference Proceeding

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Publication Title

J Parkinsons Dis


Introduction: The BouNDless study (NCT04006210) compared the efficacy, safety, and tolerability of subcutaneous levodopa/carbidopa (LD/CD) as an investigational ND0612 24-hour infusion versus oral immediate-release (IR)-LD/CD in patients with Parkinson's disease (PwP) experiencing motor fluctuations. Here we report patient enrollment characteristics; primary results will be available in 2023. Methods: Following screening, PwP on ≥4 doses/day of oral LD/dopa-decarboxylase inhibitor (LD ≥400mg/day) and experiencing ≥2.5h daily OFF-time were consented and enrolled. They entered a 4-6 week open-label adjustment period during which oral LD formulations and COMT inhibitor doses were converted to equivalent doses of IR-LD/CD and then adjusted to optimal clinical effect. Patients then entered an 4-6 week open-label ND0612 conversion period in which IR-LD/CD was replaced by ND0612 (LD/CD dose up to 720/90mg/day) with adjunct IR-LD/CD, as required, and adjusted until this combination regimen was optimal. Patients then entered a 12-week, double-blind, double-dummy period, during which they were randomized (1:1) either to their optimized regimen of ND0612 infusion (plus IR-LD/CD), or to the optimized IR-LD/CD-only regimen. Results: Enrollment characteristics of randomized patients (N=259) were similar to other clinical trials in PwP experiencing motor fluctuations refractory (mean±SD age: 63.5±9.0y; 63.7% male; diagnosed 9.6±4.3y; motor fluctuations 4.5±3.3y, mean OFF time 6.1±1.7h). Levodopa equivalent daily doses at enrollment were 1029mg; 86% patient were receiving adjunct Parkinson's medications, mainly dopamine agonists (63%). Conclusions: Enrollment characteristics of patients randomized in the BouNDless trial are consistent with those observed in other clinical studies in PwP experiencing motor fluctuations.

PubMed ID

Not assigned.



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