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IPX203-B16-02


Title A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release Carbidopa-Levodopa in Parkinson’s Disease Patients with Motor Fluctuations
Therapeutic Area Parkinson's Disease
Principal Investigator Bryan Ho, MD
Min Age 40 Years
Gender All
Contact Emma Jost-Price
617-636-7606
neuroresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03670953

Overview

The aim of this study is to test the safety and efficacy of IPX203 compared to IR CD-LD in participants with Parkinson’s disease. IPX203 is an investigational extended-release (i.e. releases drug more slowly) capsule formulation of carbidopa-levodopa (CD-LD) administered orally (by mouth).

IPX203 is being investigated to determine whether the drug is safe and potentially has a better effect than currently approved IR CD-LD. If successful, the drug could possibly improve the daily control of motor symptoms in people with Parkinson’s disease. 

Study Details

Inclusion Criteria

  • Diagnosed at age ≥ 40 years with PD, consistent with the United Kingdom Parkinson’s Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of CD-LD but experiencing motor fluctuations.
  • Subject experiences daily “wearing-off” episodes with periods of bradykinesia in combination with at least one of rest tremor or rigidity, experiences an “Off” state upon awakening on most mornings, and reports an average of at least 2.5 cumulative hours per day of “Off” time during the waking hours.
  • Able to differentiate “On” state from “Off” state as determined by at least 75% concordance with a trained rater in “On/Off” ratings for 8 ratings over a 4-hour training period.

Exclusion Criteria

  • Used any doses of controlled-release (CR) CD-LD apart from a single daily bedtime dose within 4 weeks prior to Visit 1.
  • Used any dose of Rytary for the past 4 weeks prior to Visit 1 or have had to discontinue IPX066 or Rytary for reasons of efficacy or safety.
  • Had prior neurosurgical treatment for PD or if such procedure is planned or anticipated during the study period.

Study Requirements

Study participation lasts approximately 24 weeks. You will be given study drug and asked to be asked to come to the Neurology clinic for 8 study visits including a screening visit.  You will give a total of 3 blood samples, have your vitals taken, and be administered ECGs (electrocardiograms). You will fill out questionnaires asking about how you feel and assessing your physical and neurological health. You will be asked to keep a diary recording “On” and “Off” times and when you are having certain symptoms of Parkinson’s disease.