Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations

Inclusion Criteria

• •1. Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
• •2. Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
• •3. On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
• •4. Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
• •5. Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
• •6. Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
• •7. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
• •8. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.