A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066

Exclusion Criteria

• •1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
• •2. Nonresponsive to LD therapy.
• •3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
• •4. Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
• •5. Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
• •6. History of or currently active psychosis.
• •7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
• •8. Active or history of narrow-angle glaucoma.
• •9. History of malignant melanoma or a suspicious undiagnosed skin lesion.
• •10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
• •11. Received any investigational medications during the 4 weeks prior to Screening.
• •12. Unable to swallow large pills (e.g., large vitamin pills).
• •13. Pregnant or breastfeeding.
• •14. Subjects who are unable to complete a symptom diary.