ND0612 infusion in fluctuating Parkinson's disease: A randomised, double-blind, placebo-controlled study
Stocchi F, Lewitt P, Isaacson S, Leionen M, Rachmilewitz Minei T, Oren S, Kieburtz K, and Olanow C. ND0612 infusion in fluctuating Parkinson's disease: A randomised, double-blind, placebo-controlled study. Eur J Neurol 2018; 25(Suppl 2):515.
Eur J Neurol
Background and aims: ND0612 is being developed as the first non-surgical drug-device combination that provides continuous delivery of levodopa-carbidopa (LD-CD) to patients with fluctuating Parkinson's disease (PD). Methods: iNDiGO is a multicenter, randomised, double blind, placebo-controlled clinical study. PD patients (Hoehn and Yahr ≤3) on ≥4 doses/day of LD-CD therapy, experiencing motor fluctuations (≥2h OFF time per waking day) that cannot be further improved with oral PD medications will be randomised equally to 4 treatment arms (Figure). Study treatment is added to standard-of-care oral LD-CD. Oral immediate-release LD-CD may be used as rescue therapy. The primary endpoint is change from Baseline to Week 16 in the mean percentage of OFF time during waking hours, based on patient home diary assessments on 3 consecutive days before the visit. The mean percentage of ON time without troublesome dyskinesia during waking hours will be assessed as the key secondary endpoint. Statistical analyses will use the combination of both placebo arms. Results: The goal is to conduct the study at 85 sites internationally. Conclusion: This will be the first Phase III trial of two dosing regimens (low and high) of ND0612 for establishing efficacy and safety of continuous subcutaneous levodopa delivery in patients with PD who experience motor fluctuations that are not satisfactorily controlled on conventional oral PD medications. Patients who complete the study will be offered open-label ND0612 for an extension period of additional 48 weeks of treatment.