Study Rationale:
Isradipine, an FDA-approved agent for treatment of high blood pressure, was shown to be have neuroprotective benefit in models of Parkinson’s disease (PD). A recently completed Phase II study in a PD population demonstrated that a 10 mg daily dose of isradipine is safe and well tolerated. The STEADY-PD III study, funded by the National Institutes of Health (NIH), seeks to illustrate that isradipine is helpful in slowing the rate of PD decline as measured by parameters that include motor function, cognitive function, global evaluation, and quality of life. In addition to the clinical outcome measures, the study will collect blood samples for biomarkers (objective measures of disease progression) and genetic samples that will be stored and used for future research. The biomarker and genetic sample substudy are sponsored by MJFF. The biomarker sample collection will be optional for the study participants.
Study Design:
We expect that approximately 336 people with PD will be in this 36-month study at about 56 centers in North America. This study will recruit subjects with early PD who will be randomly assigned to either 5mg of isradipine twice daily or matching placebo.
Impact on Diagnosis/Treatment of Parkinson’s Disease:
If isradipine is shown to be an effective disease-modifying intervention that will slow the progression of the disease, it will have a substantial impact on the patients’ quality of life and the economic burden of disease. Availability of the biological samples will enhance our understanding of the variables of the disease that predict response to treatment if it is shown to be effective.
Progress Report
The Phase III trial has completed recruitment, and will follow volunteers over three years.
October 2016