Adjust Text Size:
Browse Clinical Trials
Join the Email List
Sign up for our email bulletin
Participant Stories
“I participate because it is the right thing to do, for myself, for my children, and for the millions of people who have Parkinson’s disease. Without participation there will be no cure.” –Mike, Diagnosed 7 years
Recently Diagnosed with Parkinson's Disease?
If you have recently been diagnosed with Parkinson’s disease (PD) understanding the disease, and learning about the resources available to you, are good first steps.
News Archive
The Sure-PD Study: Unsuccessful Research Leads to Promising Study
Apr 27 2010
by Michael Schwarzschild, M.D., Ph.D., and Alberto Ascherio, M.D., Dr.P.H.
Parkinson’s disease (PD) patients are sometimes reluctant to participate in experimental drug trialsf because there is no guarantee of personal benefit from a study drug, or even of receiving the study drug rather than placebo. Others have no problem with these uncertainties because for them the personal benefit comes from knowing they are contributing to the discovery of new treatments that may help all people suffering from the disease. Yet even these “big picture” individuals can be discouraged from volunteering for demanding clinical research by the reality that any given drug trial faces long odds in the quest to establish a breakthrough treatment.
However, it should not be overlooked that studies that may seem to have failed at the time can provide unexpected and highly valuable data that can open doors to new ways of exploring PD. Take SURE-PD, a study of urate (uric acid) and Parkinson’s disease, for example. This research was inspired by two studies that were at least partially unsuccessful in achieving their desired outcomes, but led to preliminary data on an association between urate and Parkinson’s disease.
DATATOP, an 800 subject, government-sponsored multi-center clinical trial initiated in 1987 and published in the New England Journal of Medicine, successfully showed that the drug deprenyl (Selegiline) was effective in delaying the need to initiate levodopa therapy, though the significance of this finding was left uncertain. On the other hand, PRECEPT, an 806 subject, industry-sponsored multi-center study conducted a few years ago (2002-2003) and published in Neurology, was stopped early when the experimental drug was found not to delay the need for standard PD medication. But this initial disappointment has been replaced with excitement following a later analysis conducted on data derived from both studies by Michael A. Schwarzschild, M.D., Ph.D and Alberto Ascherio, M.D., Dr.P.H.
Schwarzschild and Ascherio with other members of the Parkinson Study Group who had conducted the DATATOP and PRECEPT trials ran an extensive analysis on cerebrospinal fluid (CSF), a clear fluid around the spinal cord and brain, and blood samples from the study cohorts and found that the progression of PD was slower in subjects who had higher levels of urate, a natural substance in the blood. The discovery fits well with the known action of urate as an antioxidant that protects cells from oxidative damage, which is akin to molecular rust that leads to the deterioration of brain cells. The findings raised the question as to whether urate might protect patients from the harmful effects of PD and thereby slow the progression of the disease. To explore this intriguing hypothesis Schwarzschild and Ascherio have undertaken a 90 subject phase II clinical trial funded by the Michael J. Fox Foundation for Parkinson’s Research (MJFF) that aims to examine the safety of raising urate levels in PD patients in an effort to develop a treatment that will slow down the disease (A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's Disease (SURE-PD)).
However, it appears that PD patients who are willing and eligible to participate in clinical trials are much harder to come by than they were in the DATATOP and PRECEPT days. SURE-PD is a prime example of scientific leads languishing due to the scarcity of volunteers among the newly diagnosed/untreated patient population. It is critical that PD patients themselves get involved – even if they don’t meet eligibility criteria for early PD studies, patients can contribute by spreading the word and letting other patients in the community know about the importance of trial participation. Without clinical trial participants, new therapies and treatments cannot be researched and developed.
Remember it doesn’t matter when you volunteer to participate in a clinical trial, or the source of the funding, or even the results of the trial because the data and specimens that you provide can help to answer today’s questions and also have far reaching use and benefits years later.
Dr. Michael Schwarzschild is an Associate Professor of Neurology at Harvard Medical School and the director of the Molecular Neurobiology Lab at the MassGeneral Institute for Neurodegenerative Diseases (Massachusetts General Hospital). Dr. Alberto Ascherio is the Professor of Epidemiology and Nutrition at Harvard School of Public Health.
Pre-study data analysis was funded by the Parkinson's Disease Foundation with study funding by the Michael J. Fox Foundation for Parkinson's Research.
Register for the Monday, May 10 PDtrials Educational Webinar, "Lessons Learned: How Completed Parkinson’s Clinical Studies Help Shape the Future," to learn more about this issue.
