Tatyana Simuni Feinberg School of Medicine, Feinberg Clinical, Neurology

Tatyana Simuni

    Feinberg School of Medicine
    Feinberg Clinical
    Neurology
    Current Appointments:

    Professor; Neurology; Feinberg School of Medicine

    Arthur C. Nielsen, Jr. Research Professorship in Parkinson's Disease and Movement Disorders; Neurology; Feinberg School of Medicine

Research Interest Keywords

Atypical Parkinsonian Syndromes, Balance Disorders, Blepharospasm, Botox Injections, Clinical Trial Methodology, Drug Discovery, Dystonia, Essential Tremor, Gait Disorders, Lewy Body Dementia, Movement Control, Movement Disorders, Parkinson's Disease

Office phone

312/503-2970

Email

Scopus Publication Detail

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Phase II safety, tolerability, and dose selection study of isradipine as a potential disease-modifying intervention in early Parkinson's disease (STEADY-PD)

Simuni Tanya

(Profiled Author: Tatyana Simuni)

Movement Disorders. 2013;28(13):1823-1831.

Abstract

Isradipine, a dihydropyridine calcium channel antagonist, has been shown to be neuroprotective in animal models of Parkinson's disease (PD). To establish a dosage of isradipine controlled-release (CR) that is tolerable and demonstrates preliminary efficacy for use in a future pivotal efficacy trial a Phase 2, randomized, double-blind, parallel group trial (Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease [STEADY-PD]) was undertaken in subjects with early PD not requiring dopaminergic therapy (dopamine agonists or levodopa) randomized 1:1:1:1 to 5, 10, or 20 mg of isradipine CR or matching placebo daily. The primary outcome was tolerability defined as no more than a 30% difference in the proportion of patients completing the study on the originally assigned dosage between an active and placebo group. If more than one isradipine dosage was tolerable, then a 3-point difference in total Unified Parkinson's Disease Rating Scale (UPDRS) change between baseline and week 52 (or time to sufficient disability to require dopaminergic therapy) was taken as a criterion for selection of the most desirable dosage for future study. STEADY-PD enrolled 99 subjects. The tolerability of isradipine was dose dependent: placebo, 25 of 26 patients (96%); 5 mg, 19 of 23 patients (83%); 10 mg 19 of 26 patients (73%); and 20 mg 9 of 24 patients (37%). There was no difference in change in UPDRS among dosages. The most common adverse events were peripheral edema (30) and dizziness (24). Isradipine 10 mg daily was the maximal tolerable dosage in this study of early PD. A large placebo-controlled trial will be necessary and is planned to assess efficacy of isradipine 10 mg daily to slow progression of PD disability. © 2013 Movement Disorder Society.


PMID: 24123224    

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