Objective: Determine the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral Carbidopa/Levodopa (CD/LD) in patients with Parkinson’s disease (PD) experiencing motor fluctuations.

Background: ND0612 is under development as the first non-surgical drug-device combination that provides continuous delivery of Carbidopa/Levodopa Subcutaneous Solution (CLSS) for patients with fluctuating PD.

Method: A total of 288 PD patients (Hoehn and Yahr ≤3) on ≥4 doses/day of CD/LD oral therapy (≥400mg of LD), experiencing motor fluctuations (average of at least 2.5 hours daily, with a minimum of 2 hours every day) in the OFF state during the waking hours) will be enrolled. The study comprises 6 periods: Period 1: Screening (1-4 weeks); Period 2: Open-label oral CD/LD adjustment period (6 weeks); Period 3: Open-label ND0612 conversion period (6 weeks); Period 4:  Double-blind, double-dummy, active-controlled, maintenance period where patients are randomized to either ND0612 infusion + Dummy IR CD/LD, OR to Dummy infusion + IR CD/LD  (12 weeks); Period 5: Optional open-label extension period (1-year); Period 6: Safety follow-up (12 weeks).

Results: The primary endpoint is the change from Baseline (start of Period 3 = start of ND0612 infusion) to end of the maintenance period (Period 4, Week 12) in mean ON time without troublesome dyskinesia, normalized to 16 waking hours, 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. Clinical assessments are by blinded-rater. Safety and tolerability are assessed via adverse event reporting, including local skin safety assessments, rates of premature discontinuation, and study treatment compliance.

Conclusion: BouNDless will be the first Phase III randomized, active-controlled trial to establish the efficacy and safety of maintenance treatment with continuous subcutaneous ND0612 in comparison to oral immediate-release CD/LD in patients with PD experiencing motor fluctuations.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/boundless-an-active-controlled-randomized-double-blind-double-dummy-study-of-continuous-nd0612-infusion-in-patients-with-fluctuating-parkinsons-disease/