The National Institute of Neurological Disorders and Stroke (NINDS) has stopped SURE-PD3, the Study of URate Elevation in Parkinson’s disease (PD), after an interim analysis showed it would be unlikely to demonstrate benefit of long-term treatment with inosine in people with PD. The trial was testing whether a treatment that raises blood levels of the natural antioxidant urate for two years slows the rate of worsening in PD. The randomized, placebo-controlled, double-blinded trial, funded by the NINDS, was conducted nationwide at 57 clinical sites of the Parkinson Study Group (PSG). It was led by investigators at Massachusetts General Hospital (MGH) and the University of Rochester, with support from the Michael J. Fox Foundation.
After two thirds of the patient data were collected, the study’s independent Data and Safety Monitoring Board (DSMB) reviewed an unblinded analysis of the primary measurement of disease progression. Study statisticians determined that even if the trial were continued so that all participants were treated for the full two years, it would unlikely show benefit of inosine by the primary measurement. Accordingly, the DSMB recommended that the study end early. The DSMB did not note any significant safety concerns though high levels of urate are known to cause gout.
Site investigators and coordinators have informed SURE-PD3 participants of the study closure. Patients will be invited to continue as volunteers in the NINDS-funded AT-HOME-PD study which focuses on how telehealth assessments via video, smartphone tracking, and computer-based questionnaires can improve the way PD trials are performed.
The SURE-PD3 trial will be closed out over the next six months, and final results are expected by the end of 2019. The NINDS is very appreciative of the efforts of patients, care givers and investigators in this important clinical trial.