Summary:
This is a multi-center, randomized, double blind, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR LD/CD.
Criteria:- Male and female patients, aged ≥30 years.
- PD diagnosis consistent with the UK Brain Bank Criteria.
- Modified Hoehn & Yahr score ≤3 during ON.
- Average of ≥2.5 hours of OFF time (≥2 hours OFF 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/DDI, e.g.,Rytary®) at a total daily dose of ≥400mg.
Qualified Participants May Receive:
Compensation for participating up to $1,900 over the study length (5 months)