Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study

Part 1: This study was a multicenter, open-label study. Subjects were to be converted from their previous CD-LD treatment to IPX066 over a 6-week period. Up to 40 subjects were to be enrolled in the study. Enrollment was defined as subjects who received study drug in Part 1 - Visit 1. Subjects were to be entered into one of two cohorts.

Approximately 24 subjects were to enroll in Cohort 1 (non-OPDM subjects) and up to 16 subjects at selected sites were to enroll in Cohort 2 (OPDM subjects). For the subjects enrolled in Cohort 2, along with the OPDM measurements, PK blood samples were also to be collected.

Part 2: Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.

Part 3: Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study.

Inclusion criteria

• Diagnosed with idiopathic PD without any known cause for Parkinsonism.
• At least 30 years old at the time of PD diagnosis.
• Currently being treated with:

• an LD dosing frequency of at least four times a day
• at least one dose of CD-LD ER daily
• requiring a total daily LD dose of at least 400 mg
• stable regimen for at least 4 weeks prior to Screening
• Concomitant therapy with amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists is 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 after completing the study.

Exclusion criteria

• Pregnant or breastfeeding
• 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.
• Planning to take during participation in the clinical study: any controlled-release LD product, additional CD or benserazide, entacapone or tolcapone, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
• Any evidence of suicidal behavior within 6 months of entering the study.
• Allergic or hypersensitive to to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
• History of or currently active psychosis.
• Active or history of peptic ulcers or surgical procedure of the stomach, the small intestine or the large intestine.
• Active or history of narrow-angle glaucoma.
• 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.
• Abnormal kidney function
• Severe hepatic impairment.
• Received any investigational medications during the 4 weeks prior to Screening.
• Previously enrolled in IPX066 studies.