biostudies-literatureZou HMichael J Fox Foundation for Parkinson&apos;s ResearchNIA NIH HHS107118https://www.ebi.ac.uk/biostudies/studies/S-EPMC12418693biostudies-literatureUnknown128<h4>Introduction</h4>Tracking of emergent symptoms (ES) in de novo Parkinson Disease (PD) patients using Parts Ib and II of the MDS-UPDRS rating scale has been proposed as an outcome measure for PD clinical trials, based on observations in the Safety, Tolerability and Efficacy Assessment of Isradipine for PD (STEADY-PD3) clinical trial.<h4>Methods</h4>Individual item-level data was extracted from the SURE-PD3 study (coded as "PD-1018" in the C-path pooled dataset). We sought to confirm the observations made in the STEADY-PD3 dataset by analyzing data from a different Phase 3 clinical trial, the Phase 3 Study of Urate Elevation in Parkinson Disease (SURE-PD3), in which MDS-UPDRS was assessed more frequently than the 12-month intervals in STEADY-PD3, using similar methodology.<h4>Results</h4Parkinsonism & related disordersValidating new symptom emergence as a patient-centric outcome measure for PD clinical trials.PMC12418693R01 AG064803P30 AG072958Zou HStebbins GTCedarbaum JMSimuni TLuo SfalseValidating new symptom emergence as a patient-centric outcome measure for PD clinical trials.<h4>Introduction</h4>Tracking of emergent symptoms (ES) in de novo Parkinson Disease (PD) patients using Parts Ib and II of the MDS-UPDRS rating scale has been proposed as an outcome measure for PD clinical trials, based on observations in the Safety, Tolerability and Efficacy Assessment of Isradipine for PD (STEADY-PD3) clinical trial.<h4>Methods</h4>Individual item-level data was extracted from the SURE-PD3 study (coded as "PD-1018" in the C-path pooled dataset). We sought to confirm the observations made in the STEADY-PD3 dataset by analyzing data from a different Phase 3 clinical trial, the Phase 3 Study of Urate Elevation in Parkinson Disease (SURE-PD3), in which MDS-UPDRS was assessed more frequently than the 12-month intervals in STEADY-PD3, using similar methodology.<h4>Results</h42024-01-01T00:00:00Z2024 Nov2026-06-02T17:38:55.68Z2026-04-18T03:11:19.31ZS-EPMC124186933935326510.1016/j.parkreldis.2024.107118