A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease

Inclusion Criteria

• Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization or local equivalent if applicable.
• Diagnosed with idiopathic PD.
• LD-naïve: defined as subjects not exposed to LD or catechol-O-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
• If currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type B (MAO-B) inhibitor, maintains a stable regimen for at least 4 weeks prior to Baseline, and agrees to maintain the stable regimen throughout study participation.
• Agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
• Able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.

Exclusion Criteria

• Pregnant or breastfeeding.
• Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome.
• Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation.
• Use of nonselective MAO inhibitors.
• Use of dopamine agonists within 30 days prior to Screening.
• Unable to tolerate a placebo regimen, in the Investigator's opinion.
• Treatment of psychosis with any antipsychotic.
• History of seizure or epilepsy.
• Active or prior medical condition or prior surgical procedure that would interfere with LD absorption.
• History of narrow-angle glaucoma.
• Subjects with a history of malignant melanoma.
• History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
• Received any investigational medications during the 30 days prior to Screening.