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SURE-PD3 (NCT 02642393) was an NINDS-funded Phase 3, randomized, double-blind, placebo-controlled, 24-month trial of urate-elevating inosine treatment to determine whether it slows clinical decline in early PD. The study was conducted at 58 PSG sites in the US, enrolling 298 participants between August 2016 and December 2017, with the last participant completing the study in June 2019 and a retention rate of 92%. The study was closed early based on a prespecified interim futility analysis. The primary outcome measure was the rate of in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS; parts I-III) total score prior to dopaminergic drug therapy initiation. Secondary outcomes included serum urate to measure target engagement, adverse events to measure safety, 29 efficacy measures of disability, quality of life, cognition, mood, autonomic function, and striatal dopamine transporter binding as a biomarker of neuronal integrity. As reported by the PSG SURE-PD3 Investigators in 2021, urate-elevating inosine treatment did not slow the progression of disability in early PD. Key secondary outcomes showed no effect of urate-elevating inosine treatment.
SURE-PD3 generated a rich dataset of study information available in the public domain. The study team strongly encouraged the investigators to take advantage of the data. The purpose of the guide below is to describe the availability of the resources from the SURE-PD3 study. The majority of the resources are datasets (spanning clinical, blood chemistry, DaTscanTM neuroimaging, and whole genome sequencing data), but there is also a reference to how to access biological (serial plasma) samples. The preceding SURE-PD (phase 2) includes a fuller set of plasma, serum, whole blood, CSF, and urine samples that are available via the Michael J. Fox Foundation biospecimens webpage.
STEADY-PD III was an NINDS funded Phase 3, parallel group, 36 month study evaluating the efficacy of isradipine 10mg daily versus placebo (1:1 randomization, ITT analysis) to slow progression of disability in de novo PD participants. The study was conducted at 54 PSG sites in the US and Canada. The study enrolled 336 participants between November 2014 – November 2015, the last participant completed the study November 20, 2018. The study retention rate was 95%. The primary outcome measure was the change from baseline in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score measured in the ON state at month 36. Secondary outcomes include change in UPDRS-III in the OFF state, time to initiation and utilization of dopaminergic therapy, time to onset of motor complications, change in non-motor disability and quality of life measures. Isradipine 10 mg daily did not slow progression of disability in early PD. Key secondary outcomes showed no effect of isradipine treatment.
STEADY-PD III generated a rich dataset of study information available in the public domain. The study team strongly encouraged the investigators to take advantage of the data. The purpose of the guide below is to describe the availability of the resources from the STEADY-PD III study. The majority of the resources are datasets, but there is also a reference to how to access the biological samples as well.
This program, in collaboration with The Michael J. Fox Foundation, supports the identification and validation of novel biomarkers through use of the DATATOP biospecimen and clinical data resources. The DATATOP (Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism) trial, conducted by the PSG in the late 1980s, also collected and banked serum, cerebrospinal fluid, urine, and DNA.
Click here to download additional details of the DATATOP trial.
Note: For projects requiring access to the DATATOP biospecimen repository, a separate proposal review and funding mechanism is now managed through NINDS at https://pdbp.ninds.nih.gov/pd-brac.
