A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

Inclusion criteria

• Diagnosed with idiopathic PD.
• At least 30 years old at the time of PD diagnosis.
• Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:

• Requiring a total daily IR LD dose of at least 400 mg
• Having a minimum dosing frequency of four times per day.
• Able to differentiate "on" state from "off" state.
• Have predictable "off" periods.
• Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
• Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

Exclusion criteria

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