Enrollment characteristics for patients entering a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612
Recommended Citation
Rascol O, Albanese A, Ellenbogen A, Ferreira JJ, Gurevich T, Hassin S, Hernandez-Vara J, Isaacson S, Kieburtz K, LeWitt P, Lopez Manzanares L, Olanow C, Pahwa R, Poewe W, Sarva H, Stocchi F, Yardeni T, Adar L, Salin L, Lopes N, Sasson N, Case R, Espay AJ, Giladi N. Enrollment characteristics for patients entering a Phase 3 study of subcutaneous levodopa/carbidopa infusion with ND0612. J Parkinsons Dis 2023; 13:291-292.
Document Type
Conference Proceeding
Publication Date
6-28-2023
Publication Title
J Parkinsons Dis
Abstract
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.
Volume
13
First Page
291
Last Page
292
