STEADY-PD III: Isradipine for Early Parkinson's Disease
The Parkinson Study Group is conducting a multi-center, randomized, double-blind, placebo-controlled study of isradipine in patients with early Parkinson disease (PD) called STEADY-PD III. This study plans to enroll newly diagnosed PD patients not yet in need of symptomatic therapy. Isradipine is already approved for the treatment of high blood pressure and has been shown to slow the progression of PD by protecting dopaminergic neurons in animal models. A total of 336 subjects will participate in study, it is anticipated that 6-8 subjects will be enrolled at Rush University Medical Center. Eligible subjects eligible will be asked to complete at least 12 in-person visits at Rush after the Screening Visit and 4 follow-up phone calls throughout the study. Subject participation in the study will last approximately 36 months.
In order to participate you must meet the following criteria:
- Have early idiopathic PD (presence of two out of three cardinal features of PD).
- Have been 30 yrs or greater when diagnosed with PD.
- Have a diagnosis of PD less than 3 years.
- Are not currently be taking dopaminergic therapy.
You will be excluded from the study if any of the following criteria apply to you:
- Have atypical Parkinsonism.
- Are unwilling or unable to give informed consent.
- Have taken dopaminergic PD therapy within 60 days prior to baseline visit or for consecutive 3 months or more at any point in the past.
- A history of clinically significant orthostatic hypotension or presence of orthostatic hypotension at the screening or baseline visit.
- History of congestive heart failure or clinically significant bradycardia.
This is a partial list of inclusion and exclusion criteria.