This study will allow evaluation of long-term safety and clinical effects as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 (?core study', a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase III study to assess the safety and efficacy of AP-CD/LD versus IR CD/LD in fluctuating PD patients).
This study will assess the effectiveness, safety and tolerability of Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) compared to Immediate Release Carbidopa/Levodopa (IR CD/LD) (Sinemet) in patients with fluctuating Parkinson's disease (PD).
This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.
This is a prospective, multi-center, open-label, Phase 3 study in Levodopa responsive PD patients with motor fluctuations, designed to evaluate the long-term safety, tolerability and efficacy of APL-130277. APL-130277 is being evaluated as a "rescue" treatment for OFF episodes.
The overall number of subjects is not pre-specified as this is an extension
Patients who have completed any of the following studies: CTH-201,
CTH-203, CTH-300, CTH-301, or CTH-302 will be eligible to enroll into
this study. In addition, approximately one hundred (100) de novo patients
will also be enrolled.