Efficacy of Isradipine as a disease modifying agent in early Parkinson 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.
In order to qualify for participation in the STEADY-PD III study, you must:
- Have a diagnosis of PD of less than 3 years
- Be over 30 years old at the time of diagnosis
- Be able to provide written informed consent
- Be able and willing to comply with study specific procedures
- Not be taking dopaminergic therapy at the time of study enrollment
- Not be pregnant, lactating or intend to become pregnant
- Early idiopathic PD
- Subject equal or greater to 30 years of age with diagnosis of PD less than 3 years
- Hoehn or Yahy stage less than or equal to 2
- Currently NOT receiving dopaminergic therapy and not projected to require therapy for 3 months
- Amantadine and/or anticholinergics allowed if at a stable dose 8 weeks prior to baseline visit
- Subjects with a diagnosis of atypical Parkinsonism
- Exposure to dopaminergic PD therapy within 60 days prior to baseline visit or for at least 3 months prior at any point
- History of clinically significant orthostatic hypotension
Further restrictions on participation will be provided to you by your local study research team.
What are the study procedures?
If you are interested in participating in the STEADY-PD III study, you will first have a visit with the study doctor to determine if you are eligible to participate. If you qualify, then you will have a second visit to evaluate your general health, mood and movement. Blood samples will be taken at specific visits.
During the study you will be assigned randomly to receive either the active study drug, or a pill that looks like the study drug but has no active ingredients. You will continue to take the study drug or placebo for a total of 36 months. Your total participation time will be 37 months. There are 12 office visits and 4 telephone visits scheduled for this study to evaluate your general health, mood, movement ability to tolerate the study drug.
What are the risks associated with participation in STEADY-PD III?
There are mild risks associated with taking blood samples that include pain or bruising at the site where the blood is taken. Some of the side effects noted for this medication are chest pain, fast or slow heart beat, dizziness and shortness of breath. Further detail on these risks is explained in the consent form.
To learn more about STEADY-PD III, please visit http://www.STEADYPD3.com, http://www.clinicaltrials.gov or call 1-855-825-3390.
If you would like information from your local study team, please contact Aaron Daley, MA at Aaron.Daley@ucsf.edu