Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's Disease

Exclusion Criteria

• •Patients will be excluded from participating in this study if 1 or more of the following criteria are met:
• •Have atypical Parkinsonism due to drugs, metabolic disorders, encephalitis, or other neurodegenerative diseases
• •Have confirmed diagnosis of Parkinson's disease for more than 5 years
• •Have a tremor score of 3 or more in any body part
• •Have any other known medical or psychiatric condition that may compromise participation in the study
• •Have a history of prior malignancy (excluding basal or squamous cell cancer of the skin) within the previous 5 years
• •Have an unresolved abnormal cancer screening test result before randomization
• •Have greater than trace amounts of glycosuria at screening, except for known diabetic patients
• •Have estimated creatinine clearance less than 50 mL/min
• •Have liver function tests (LFT) greater than 3 times the upper limit of normal (ULN)
• •Have any other clinically significant ECG or laboratory finding
• •Have any history of malignant melanoma
• •Have history of seizures (except febrile) or posttraumatic epilepsy
• •Have Mini-Mental State Exam (MMSE) score ≤ 26
• •Have taken another investigational drug within 60 days before the baseline visit
• •Have received prior treatment with CEP-1347
• •Have received treatment with agents with potentially confounding anti-Parkinson's disease effects, with specified substrates for CYP3A4/5, or with inhibitors of CYP3A4/5
• •Received treatment within 6 months before the baseline visit with agents that may induce Parkinson's disease
• •Are expected, within the next 3 months, to reach a level of disability sufficient to require dopaminergic therapy
• •Have BECK depression score ≥ 15
• •Have known or suspected sensitivity to the investigational study drugs, including B-CIT