12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa

Exclusion Criteria

• •1. Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
• •2. Treatment with MAO inhibitors except selegiline.
• •3. Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
• •4. Neurosurgical surgery for Parkinson's disease.
• •5. Atypical parkinsonism or secondary parkinsonism variants.
• •6. Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST \> 1.5 times the upper limit of normal).
• •7. Mini-Mental Status Examination score of 25 or less.
• •8. History of drug or alcohol abuse or dependence within 2 years.
• •9. History of psychotic illness or seizures.
• •10. Current clinically relevant depression disorder.
• •11. History of neuroleptic malignant syndrome.
• •12. Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.