Objective: To evaluate the efficacy of isradipine 10 mg daily on PD disability.

Background: Isradipine, a dihydropyridine calcium channel antagonist with excellent penetration of the blood brain barrier, has been shown to be neuroprotective in in vitro /in vivo models of parkinsonism. Epidemiological data also points to a reduced risk of Parkinson’s disease (PD) with chronic use of dihydropyridines. Our recently completed Phase II study found that isradipine 10 mg daily is safe and well tolerated in participants with early PD). Finally, this dosage of Isradipine achieves serum concentrations within the range found to be neuroprotective in animal models of PD.

Methods: The study is as a 36 month, Phase 3, parallel group, placebo-controlled study of the efficacy of isradipine 10mg daily versus placebo on the progression of PD disability in 336 participants with early PD as measured by the change in the Unified Parkinson’s disease Rating Scale (UPDRS) Part I-III score over 36 months. Secondary outcome measures include a number of clinically meaningful and widely accepted measures of progression of disability in early PD including:1) Time to initiation and utilization of dopaminergic therapy; 2) Time to onset of motor complications; 3) Change in non-motor disability. Exploratory measures will include global measures of functional disability, quality of life, change in the ambulatory capacity (sum of 5 UPDRS items: falling, freezing, walking, gait, postural stability), cognitive function and pharmacokinetic analysis.

Results: The study was funded by NINDS and is being conducted at 56 Parkinson Study Group sites in US and Canada. The complete cohort (n=336) was enrolled in 12 months, 6 months ahead of schedule, on October 28, 2015. The mean age is 61.7±9.6 years, 230 (68%) are males and 34 (10%) are minorities. Participants mean (±SD) Hoehn and Yahr 1.7 (0.5), Total UPDRS 23.2 (8.6) and years from diagnosis 0.9 (0.8).

Conclusions: STEADY-PD III is fully enrolled and the population is similar to other early PD clinical trial cohorts. This study represents a unique opportunity to evaluate the potential impact of a novel therapy to slow progression of PD disability and provide clinically meaningful benefits.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/steady-pd-iii-a-phase-3-study-of-isradipine-as-a-disease-modifying-agent-in-patients-with-early-parkinsons-disease-baseline-characteristics-of-the-enrolled-cohort/