A Phase 3 double-blind placebo-controlled parallel group study of isradipine as a disease modifying agent in subjects with early Parkinson disease (STEADY-PD III Study)

WHAT IS THE TITLE OF THE STUDY?

A Phase 3 double-blind placebo-controlled parallel group study of isradipine as a disease modifying agent in subjects with early Parkinson disease (STEADY-PD III Study)

WHAT IS THE PURPOSE OF THE STUDY?

The purpose of STEADY-PD III Study is to assess the potential effect of isradipine on slowing the progression of Parkinson disease.

Isradipine is a medication that is approved for the treatment of high blood pressure by the U.S. Food and Drug Administration Agency (FDA), but not for the treatment of PD. Isradipine has been shown to slow the progression of PD by protecting dopaminergic neurons in animal models.

This study plans to enroll newly diagnosed PD patients not yet in need of symptomatic therapy. Participants will be assigned randomly (like a flip of a coin) to receive either the active study drug, or a pill that looks like the study drug but has no active ingredients (placebo).

WHO IS NEEDED?

To pre-qualify for this study, the participant must:

  • Have a diagnosis of PD of less than 3 years
  • Be at least 30 years old at the time of diagnosis
  • Not be taking dopaminergic therapy at the time of study enrollment
  • Not be pregnant, lactating or intend to become pregnant during the course of the study
  • Further restrictions apply

WHAT IS INVOLVED IF I PARTICIPATE?

Duration: There are up to 12 office visits and 4 phone calls over a period of approximately 36 months.

Tests/procedures: Physical and Neurological exams, questionnaires, blood draws, and urine tests. The study drug/placebo is administered in a pill form, which is swallowed.

Risks: Risks will be discussed with volunteers as part of the informed consent process.

Benefits: Participation might help future patients with PD.

Compensation: Volunteers may be reimbursed for their travel expenses.

WHO IS THE PRINCIPAL INVESTIGATOR (DOCTOR)?

Brad Racette, MD

WHERE WILL THE STUDY TAKE PLACE?

Washington University School of Medicine
Contact Name: Karen McDonell 314-747-0514 or mcdonellk@neuro.wustl.edu

For other study information, please visit www.STEADYPD3.com or www.ClinicalTrials.gov