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Parkinson's Disease OFF Episodes Drug Treatment Study

Clinical Trial Title: 
A phase 3 study to examine the efficacy, safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson's disease.
Clinical Trial Protocol ID: 
15030301
Clinical Trial Investigator Name: 
Christopher G. Goetz, MD
Clinical Trial Protocol Description: 

This purpose of this study is to determine the effectiveness, safety, and tolerability of multiple treatments of APL-130277 in patients with Parkinson’s disease who experience OFF episodes. There will be a total of approximately 126 patients that will participate in this study. Up to 6 subjects are anticipated to be enrolled at Rush University Medical Center. There will be up to 13 clinic visits, including the screening and follow up visits, and an at-home treatment period. This research will take approximately 135 days, and treatment will be over approximately one hundred days.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a clinical diagnosis of idiopathic PD.
  • Have a clinically meaningful response to L-Dopa with well-defined early morning OFF episodes, as determined by the investigator.
  • Are receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR RytaryTM administered 3 times per day, for at least 4 weeks before the initial screening visit.
  • Have no planned medication change(s) or surgical intervention during the course of study.
  • Experience at least one well defined OFF episode per day with a total daily OFF time duration of ≥ 2 hours during the waking day, based on patient self-assessment.

You will be excluded from the study if any of the following criteria apply to you:

  • Have atypical or secondary parkinsonism.
  • Have been previously treated with any of the following:
    • A neurosurgical procedure for PD.
    • Continuous s.c. apomorphine infusion.
    • Duodopa/Duopa. 
  • Have received treatment with any form of subcutaneous apomorphine within 7 days prior to the initial screening visit (SV1).

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Parkinson's Disease and Other Movement Disorders
Contact Phone: 
(312) 563-2900 (Press 4/code: Apo Film)
Contact Name: 
Kim Janko, BSN, RN