BouNDless is a Phase-III randomized, active-controlled, double-blind, double-dummy trial designed to establish the efficacy, safety, and tolerability of ND0612 in comparison to oral immediate-release levodopa/carbidopa in patients with Parkinson’s Disease experiencing motor fluctuations.
The primary endpoint is the change, from baseline to end of maintenance period, in mean ON time without troublesome dyskinesia using patient-rated ON/OFF diary assessments. Secondary outcome measures include changes in: OFF time (key secondary), UPDRS (Parts II and III), Patient’s and Clinician’s Global Impressions of Change, ON time without dyskinesia, PDQ-39, and Parkinson’s Disease Sleep Scale (PDSS) scores. Safety and tolerability are assessed via adverse event reporting, including local skin safety assessments, rates of premature discontinuation, and study treatment compliance. The study is currently recruiting in over 100 sites across 16 countries in North America, Europe, and Israel. More information can be found on clinicaltrials.gov or on the BouNDless Study website.