Phase III Trial to Slow Parkinson’s Now Recruiting around The United States


A compound that researchers believe may lower the risk of Parkinson’s disease (PD) and slow progression is now in the final stage of clinical testing. The Safety of Urate Elevation in Parkinson’s Disease Phase III study (SURE-PD3) is recruiting people diagnosed with Parkinson’s within the last three years.

Phase III Trial to Slow Parkinson's Now Recruiting around The United States

SURE-PD3 aims to enroll 270 people across 60 U.S. clinical sites for the two-year study. Twenty-six sites are now actively recruiting.

Find a list of those sites and contact information for study coordinators on Fox Trial Finder.

Earlier observational studies showed that individuals with higher levels of the antioxidant urate were less likely to get PD or, if they were diagnosed with PD, the disease progressed more slowly. The compound inosine is converted by the body into urate. A Phase II trial, funded by The Michael J. Fox Foundation (MJFF), showed that taking inosine increases urate levels in the blood and brain and is both safe and tolerable. The National Institutes of Health is funding the Phase III study, which is led by the Parkinson Study Group, a non-profit network of Parkinson’s centers.

Please note: Inosine is available commercially as a dietary supplement, but has not been approved as a therapy for PD. In the absence of medical supervision, it can cause serious side effects, such as gout, kidney stones and possibly high blood pressure. It’s critical to discuss any medications or natural supplements with your doctor before taking them.

The development of disease-modifying therapies is a critical goal of our Foundation. The Phase II study funding of more than $5 million was MJFF’s largest single grant at that time. MJFF also supported early pre-clinical work investigating the mechanism of urate in neuroprotection and studies into the interaction of inosine with diet and with other Parkinson’s medication. In addition, we are funding a sub-study within SURE-PD3 to collect biospecimen samples from participants, including plasma and DNA, for future biomarker research.

SURE-PD3 will also collect additional data from some participants using the smartphone app mPower, which uses phone sensors to track symptoms of PD. Integrating wearable technology into SURE-PD3 may bolster participant engagement and can provide researchers with greater information on how the study drug affects the progression of motor symptoms.

Individuals diagnosed with PD within the past three years who have low blood urate levels and show dopamine loss on an imaging DaTscan, among other criteria, are eligible for the SURE-PD3 trial.

New tools automatically match patients with clinical trials.


The majority of Americans—72%—say they would take part in a clinical trial recommended by their doctor, according to a survey released last month by the Alexandria, Virginia-based science advocacy group Research!America. Despite that enthusiasm, though, there’s a shortage of enrollment. According to US government estimates, only about 3% of patients with advanced cancer enroll in phase 1 trials. Part of the problem, experts believe, comes down to a lack of awareness: the general public doesn’t know about investigational trials, and few physicians discuss the option with their patients.

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New tools unveiled this year that automatically prescreen patients for trials based on their electronic medical records and email matches to doctors could help solve the problem. “We’ve needed these kinds of tools for a long time,” says Eric Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, California. “Physicians are really busy, and there are so many clinical trials that no human could track them all.”

The US federal registry, ClinicalTrials.gov, currently lists more than 145,000 trials in all 50 states, as well as 184 foreign countries. Wading through those listings is a daunting task for individuals interested in signing up for a study, assuming that they know of the resource to begin with. Ultimately, problems with patient recruitment delay clinical trials by 4.6 months, on average, according to the Center for Information and Study on Clinical Trial Research Participation, a nonprofit organization in Boston. That holdup means it takes longer for treatments to reach the market.

To increase enrollment, some patient-advocacy groups have started playing matchmaker. A year ago, the Michael J. Fox Foundation for Parkinson’s Research launched the Fox Trial Finder, a web portal designed to help pair people with Parkinson’s with clinical studies (see Nat. Med. 18, 837,2012). The Alzheimer’s Association’s TrialMatch, meanwhile, has been up and running since 2010. Anyone can register online or by phone and see if he or she—or a patient or loved one—is a good fit for any of the 153 trials in 621 locations. To date, there have been 11,166 referrals, says Heather Snyder, the Chicago-based association’s director of medical and scientific operations.

In addition to the Fox Trial Finder and TrialMatch, for-profit companies have unveiled web portals to link people with studies. New York’s EmergingMed helps connect individuals with cancer trials, and in late May, Michigan-based CureLauncher unveiled a clinical-trial-matching service for a range of disorders. But tools such as these rely on the gumption of patients and doctors to wade through web listings. A new wave is emerging of automated tools that do away with the need for patients or physicians to manually enter information.

On alerts

Earlier this year, the Virginia Commonwealth University’s Massey Cancer Center in Richmond unveiled two new tools that work with its Clinical Trials Eligibility Database, which stores information about patients and clinical trials at the center. Since February, its MD Alert Notification System has automatically prescreened the list of scheduled patients each morning and emailed physicians when it finds that one of those individuals is eligible for one or more of 75 open trials at the center.

“If the patient is interested, one click by the physician refers them to the research nurse associated with that trial,” says Lynne Penberthy, director of the Massey Cancer Center’s informatics core who oversees the tracking and matching tools. Another new computer application there, the Automated Matching Tool, has been available since January. It screens all patients in the system on a scheduled basis, not just those coming in for a visit.

An algorithm known as Trial Prospector offers even greater automation for clinical trial enrollment. In a pilot study presented at last month’s American Society of Clinical Oncology meeting in Chicago, the program reached into the medical records of 60 people with gastrointestinal cancer who had scheduled appointments at the University Hospitals Seidman Cancer Center of the Case Comprehensive Cancer Center in Cleveland, Ohio. It pulled out 15 pieces of information—including age, diagnosis and blood count—that it compared to eligibility criteria of the 300-plus trials in Cases’s database. It then emailed doctors lists of any matches, and it also shows the studies for which the patient didn’t qualify and explains why; for example, some factors, such as low red blood cell count, might be easily fixed with a transfusion. The algorithm was 100% accurate, and 11% of the patients ended up enrolling in a trial suggested to the doctor by the algorithm.

“In theory this could be readily adapted anywhere, but we’ve still got a long way to go,” says Neal Meropol, associate director for clinical research at the Case Comprehensive Cancer Center. His team plans to refine Trial Prospector over the next 6 to 12 months, expand it to other cancers, and test it in a community-practice setting, where physicians aren’t highly specialized and may not have as much knowledge of open trials.

Penberthy similarly sees automated trial matching tools as a way to reach a more diverse set of participants. “We’re hoping that this is going help increase the equity,” she says. “It may help to increase minority patients enrolled in clinical trials,” an underrepresented population.

Topol, who isn’t involved with the programs, says that although automated matching programs are in their infancy, “eventually they could build something that’s extraordinary.”

Source: Nature