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

Inclusion Criteria:

1. Male and female patients, aged ≥30 years.

2. PD diagnosis consistent with the United Kingdom Brain Bank Criteria.

3. Modified Hoehn & Yahr score ≤3 during "ON" state.

4. Average of ≥2.5 hours of OFF time (≥2 hours "OFF" time every day) during wakinghours as confirmed by patient diary over 3 days.

5. Taking ≥4 levodopa doses/day (≥3 doses/day of extended release LD/dopa-decarboxylaseinhibitor, e.g., Rytary®) at a total daily dose of ≥400mg.

Exclusion Criteria:

1. Atypical or secondary parkinsonism.

2. Severe disabling dyskinesias, based on Investigator's discretion.

3. Previous neurosurgery for PD.

4. Use of duodenal levodopa infusion (LCIG) or apomorphine infusion.

5. Use of the following medications: subcutaneous apomorphine injections, sublingualapomorphine, or inhaled levodopa within 4 weeks.

6. Previous participation in ND0612 studies.

7. History of significant skin conditions or disorders.