Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

This is a phase III multi-center, randomized, active-controlled, double-blind, double-dummy (DBDD), parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous (SC) ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson's disease (PD) experiencing motor fluctuations.

This study is comprised of 6 periods:

• a Screening Period;
• an open-label oral IR-LD/CD Adjustment Period;
• an open-label ND0612 Conversion Period;
• a randomized DBDD active-controlled Maintenance Period;
• an optional open-label Treatment Extension; and
• a Safety Follow-up Period.

Inclusion criteria

• Male and female patients, aged ≥30 years.
• PD diagnosis consistent with the United Kingdom Brain Bank Criteria.
• Modified Hoehn & Yahr score ≤3 during "ON" state.
• Average of ≥2.5 hours of OFF time (≥2 hours "OFF" time every day) during waking hours as confirmed by patient diary over 3 days.
• Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/dopa-decarboxylase inhibitor, e.g., Rytary®) at a total daily dose of ≥400mg.

Exclusion criteria

• Atypical or secondary parkinsonism.
• Severe disabling dyskinesias, based on Investigator's discretion.
• Previous neurosurgery for PD.
• Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.
• Use of the following medications: subcutaneous apomorphine injections, sublingual apomorphine, or inhaled levodopa within 4 weeks.
• Previous participation in ND0612 studies.
• History of significant skin conditions or disorders.