Parkinson's Disease OFF Episodes Drug Treatment Study
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.
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.
- 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.