The iNDiGO study: A multicenter, randomized, double-blind, placebo-controlled clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in fluctuating PD (P2.044)

Objective: To determine the effect of two dosing regimens of ND0612 on daily OFF-time using subject completed home-diary assessments of motor function. Background: Continuous levodopa/carbidopa (LD/CD) infusion may improve clinical response in advanced Parkinson’s disease (PD) patients with motor fluctuations because it avoids the LD peaks and troughs associated with oral LD/CD administration. ND0612 is a LD/CD solution with an LD concentration of 60 mg/mL and CD concentration of 7.5 mg/mL designed to be administered via continuous subcutaneous infusion using an infusion pump system. Design/Methods: iNDiGO (NCT02782481) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group 16-week (4-week dose adjustment period + 12-week maintenance period) Phase 3study designed to demonstrate clinical benefit. Following a screening period, subjects (≥30y) with PD (H&Y ≤3 during ON) and motor fluctuations (≥2h daily OFF-time/waking day) with current LD therapy will be randomized (2:2:1:1) to one of four treatment arms: low-dose ND0612, high-dose ND0612, low-dose ND0612 placebo and high-dose ND0612 placebo. Placebo arms will be combined for analysis. The primary endpoint is the change from baseline to Week 16 in the mean percentage of OFF-time during waking hours (normalized to 16 waking hours). The key secondary efficacy endpoint is the change from Baseline to Week 16 in the mean percentage of ‘good’ ON-time (ON-time without troublesome dyskinesia) during waking hours. At the end of the 16-weeks, subjects will be offered to continue with open-label. Results: Study recruitment is ongoing with a planned sample size of 240 randomized subjects. Conclusions: This will be the first Phase 3 trial with ND0612, designed to demonstrate the potential clinical utility of this intervention in managing PD with motor fluctuations. Study Supported by: NeuroDerm Disclosure: Dr. Kieburtz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Research grants from the National Institutes of Health, the Michael J. Fox Foundation, Medivation, and Neurosearch. Consultant to the United States Food and Drug Administration, Veterans Administration, and National Institutes of Health, AbbVie, Acorda, A. Dr. Olanow has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant to AbbVie, Addex, Lundbeck, Newron, Novartis, Teva, and Zambon. Owns stock in Clintrex which provides consulting services for Acorda, AstraZeneca,Biotie, Cynapsus, EMD Serono, Dart Neuroscience, Jazz, Knopp, Kyowa Kirin, Lundbeck, Melior Discov. Dr. Rahmilevich has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with NeuroDerm. Dr. Cohen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with NeuroDerm. Dr. Oren has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with NeuroDerm.