Pioglitazone in Early Parkinson’s Disease (FS-ZONE)

The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies.  Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The NIH Exploratory Trials in Parkinson’s Disease (NET-PD) is conducting a clinical trial of pioglitazone in people with early PD.  The purpose of this study is to determine if pioglitazone is safe, tolerated, and effective in slowing the progression of PD symptoms.  The study also will examine potential biological characteristics, or biomarkers, for PD.

Pioglitazone is an FDA-approved medication for treatment of type II diabetes, however it is currently not approved for PD treatment.  Early animal research suggests pioglitazone may help to slow the progression of PD.

In the study—which will be conducted at about 39 research centers across the United States—216 men and women with early PD will receive pioglitazone or a matching placebo (an inactive substance).  Researchers will compare two doses of pioglitazone (15 and 45 milligrams) with a placebo to find out how it effects the progress of PD symptoms over 44 weeks.  The study involves six in-person visits and one telephone call over 48 weeks, and includes a survey called the Unified Parkinson’s Disease Rating Scale (UPDRS), an ECG (electrocardiogram), and blood and urine samples.

This research is supported by a grant from the National Institute of Neurological Disorders and Stroke.  Supplemental funding is provided by the Michael J. Fox Foundation.

Phase: 

Eligibility Criteria:

To be eligible for the study, volunteers must:

• Be 30 years of age or older
• Have early Parkinson’s disease (less than 5 years from date of diagnosis)
• Be taking a stable dose of rasagiline (Azilect®) 1mg/day or selegiline (Eldepryl®) 10mg/day for at least 8 weeks but not more than 8 months
• Not be expected to require additional symptom treatment in the coming year
• Not have diabetes
• Not have a history of heart failure or bladder cancer
• Not be taking levodopa (Sinemet®) or dopamine agonists such as pramipexole (Mirapex®) or ropinerole (Requip®).
• Generally be in good health

*There are other restrictions to participation that you can discuss with the study team.

Study Design: 

Study Locations: 

For more information and more detailed Eligibility Criteria:

Contact:  Liana Baker, MPH ; Tel: 585-276-4831; Email: liana.baker@chet.rochester.edu

Visit:  http://parkinsontrial.ninds.nih.gov or http://clinicaltrials.gov/ct2/show/NCT01280123.

Last Reviewed February 11, 2013