STEADY-PD3 Study Overview
STEADY-PD3 was conducted as a randomized Phase 3, 2-arm, double-blind, parallel group trial with subjects randomized to Isradipine immediate release 5 mg or matching placebo twice daily for 36 months. The primary efficacy measure was the change in the total UPDRS score in the active treatment arm versus placebo between the baseline and 36 months. If patients needed to start symptomatic therapy, they continued on their randomized treatment assignment in conjunction with the symptomatic therapyand primary outcome was assessed in the medications ON state. The primary analysis was based on the intent-to-treat principle and included all subjects who had 36 month data. The study had 95 % retention rate.
The study was negative for the primary outcome, showing no difference in PD symptoms over the 3 years of the study between the active and placebo arms.
Total Participants (Cohort records that met the AMP PD minimum clinical data criteria):
AMP PD Designation:
Data from the STEADY-PD3 cohort is designated with the prefix “TBD” in the AMP PD Portal. STEADY-PD3 data in the AMP PD portal includes: Demographics, family history, medication history, UPSIT, MDS-UPDRS, MoCA, WGS, blood transcriptomics for Baseline and 36-Month Visit Types.
Additional Study Information:
STEADY-PD3 Goals and Objectives
To describe the rationale for a novel study design and baseline characteristics of a disease-modifying trial of isradipine 10 mg daily in early Parkinson disease (PD) and to assess the potential effect of isradipine on slowing the progression of PD.
Study Specific Data Contribution
STEADY-PD3 Inclusion and Exclusion Criteria
In order to qualify for participation in the STEADY-PD III study, you must: (source: https://steadypd3.com/3-2/)
STEADY-PD3 Study Protocol
STEADY-PDIII is a 36-month, Phase 3, parallel group, placebo-controlled study of the efficacy of isradipine 10 mg daily in 336 participants with early PD as measured by the change in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score in the practically defined ON state. Secondary outcome measures include clinically meaningful measures of disability progression in early PD: (1) Time to initiation and utilization of dopaminergic therapy; (2) Time to onset of motor complications; (3) Change in nonmotor disability. Exploratory measures include global measures of functional disability, quality of life, change in the ambulatory capacity, cognitive function, and pharmacokinetic analysis. Rationale for the current design and alternative design approaches are discussed.
Participants first have a visit with the study doctor to determine if you are eligible to participate. For qualifying participants, a second visit will be scheduled to evaluate your general health, mood and movement. Blood samples will be taken at specific visits.
During the study you will be assigned randomly to receive either the active study drug, or a pill that looks like the study drug but has no active ingredients. You will continue to take the study drug or placebo for a total of 36 months. Your total participation time will be 37 months. There are 12 office visits and 4 telephone visits scheduled for this study to evaluate your general health, mood, movement ability to tolerate the study drug.