Clinical Research Study for Individuals with Parkinson’s Disease (PD) who are currently being treated with Carbidopa-Levodopa (CD-LD) (Sinemet) but who are still experiencing periods of “off” time during waking hours.

Purpose The primary objective of the IPX203 development program is to design a product that can attain therapeutic LD plasma concentrations rapidly and maintain constant LD plasma concentrations for a longer duration than currently approved products.
Summary Parkinson’s disease is a slowly progressive degenerative brain disorder which causes patients to experience disabling motor symptoms (tremor, stiffness, slowness, balance and walking difficulties).  These motor symptoms are sometimes referred to as “off” time and are thought to be caused by the loss of the brain’s dopamine-producing nerve cells.  Levodopa, which is converted by the brain into dopamine, is used in combination with carbidopa to treat the motor symptoms of PD and is considered the treatment standard. The addition of CD to LD increases the amount of LD which reaches the brain.  Therapy with levodopa replaces the missing dopamine. However, as the population of dopamine-producing nerve cells decreases, brain dopamine levels become increasingly dependent on plasma levodopa levels. This process is believed to be an important factor causing the motor complications encountered with levodopa: dyskinesia (abnormal involuntary movements) when plasma levodopa levels are high and “off” time (“wearing off”) when plasma levodopa levels are low.   The management of motor complications represents a major unmet need in the treatment of PD. IPX203 is an investigational new drug product containing CD-LD that is being developed by Impax Laboratories, Inc. through its Impax Specialty Pharma division (Impax).
Diagnosis and Main Criteria for Study Individuals diagnosed with Parkinson’s disease who are experiencing motor complications (“off” time and dyskinesias), and who are currently being treated with CD-LD (Sinemet).
Duration of Treatment The study duration will be approximately 6 weeks, including the screening period.
Qualification
To see if you qualify to participate in this trial call us today toll-free at 877-547-8839.  We look forward to speaking with you.
  • Parkinsons, Patient Enrollment