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.