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PDF-Funded Research Paves the Way to Phase III Drug Trial
PDF Research Advocates Advising Trial into Nutritional Supplement Inosine
- Sep 02 2015
The Parkinson’s Disease Foundation (PDF) is pleased to announce that research initially launched with PDF funding will be tested in a phase III clinical trial opening in 2016. The study, which two of PDF’s volunteer Research Advocates are helping to oversee, is assessing the potential of the nutritional supplement inosine for the treatment of Parkinson’s disease.
Several studies, including early research funded by PDF in 2007 through its grant to the Parkinson Study Group, have shown that high levels of urate (a naturally occurring salt in the body) are associated with slower rate of progression in Parkinson’s disease. The PDF-funded retrospective study entitled, "Predicting PD Progression Subtypes by CSF Urate Pathways,” led by Michael Schwarzschild, M.D., Ph.D., of MassGeneral Institute of Neurodegenerative Disease, looked at urate levels in thousands of people with PD who had participated in clinical trials.
This early research paved the way for Dr. Schwarzschild to study a nutritional supplement called inosine, which the body converts to urate, for its potential as a treatment for Parkinson’s disease. This research has now progressed to a phase III clinical trial called SURE-PD3 (Study of URate Elevation in Parkinson’s Disease) — the final stage of research before a new treatment can be approved by the US Food and Drug Administration (FDA) for use by the public.
PDF is pleased that two of its Research Advocates have active roles on the clinical trial — representing the Parkinson’s community and ensuring that the patient perspective is central.
Becky Houde, J.D. of Boston, MA: is a member of the SURE-PD3 steering committee, the group that oversees and supervises the trial.
Joel Grace, Ph.D., of Big Flats, NY: is a member of the SURE-PD3 Data Safety and Monitoring Board, the group that monitors the safety of all trial participants.
Enrollment for the double-blinded placebo-controlled trial will begin in 2016, and will seek 270 people living with early-stage Parkinson’s to investigate whether moderate urate elevation resulting from two years of inosine treatment slows PD progression. It will be conducted at 60 Parkinson Study Group sites across the US and is supported by the National Institute of Neurological Disorders and Stroke.
For further information on this research or the role of patient advocates, contact the PDF HelpLine at email@example.com or (800) 457-6676. Enrollment is not yet open but information will be available next year.
Source Date: Sep 03 2015