Evidence map›Paper›PMID 28589163›Full record

ArticleAnnals of clinical and translational neurology2017

A novel design of a Phase III trial of isradipine in early Parkinson disease (STEADY-PD III).

Kevin M Biglan, David Oakes, Anthony E Lang, Robert A Hauser, Karen Hodgeman, Brittany Greco, Jillian Lowell, Rebecca Rockhill, Ira Shoulson, Charles Venuto and 3 more

Open access · goldAbstract read
In one paragraph

Article in Annals of clinical and translational neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
7.0field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 70 citations in OpenAlex.

  1. Trial
  2. Trial
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  4. Televisits for Parkinson's disease: benefits and barriers.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
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  6. Disease-modifying, multidimensional efficacy of putaminal CaMolecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article
  7. Article
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  9. Article
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  12. Article
  13. Article
  14. Identification of Sclareol As a Natural Neuroprotective CaAdvanced science (Weinheim, Baden-Wurttemberg, Germany) · 2022
    Article
  15. Article
  16. Article
  17. Article
  18. Observational
  19. Voltage-Gated CaFrontiers in synaptic neuroscience · 2021
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 2 countries.

Kevin M BiglanDepartment of Neurology University of Rochester Rochester New York.
David OakesDepartment of Biostatistics and Computational Biology University of Rochester Rochester New York.
Anthony E LangMorton and Gloria Shulman Movement Disorder Unit & Edmond J. Safra Parkinson Disease Program Neurology Division Department of Medicine Toronto Western Hospital University Health Network, University of Toronto Toronto Ontario Canada.
Robert A HauserDepartment of Neurology University of South Florida Tampa Florida.
Karen HodgemanCenter for Human Experimental Therapeutics University of Rochester Rochester New York.
Brittany GrecoCenter for Human Experimental Therapeutics University of Rochester Rochester New York.
Jillian LowellDepartment of Neurology University of Rochester Rochester New York.
Rebecca RockhillCenter for Human Experimental Therapeutics University of Rochester Rochester New York.
Ira ShoulsonDepartment of Neurology and Program for Regulatory Science & Medicine Georgetown University Washington District of Columbia.
Charles VenutoCenter for Human Experimental Therapeutics University of Rochester Rochester New York.
Diony YoungParkinson Disease Foundation New York City New York.
Tanya SimuniDepartment of Neurology Northwestern University Chicago Illinois.
Parkinson Study Group STEADY‐PD III Investigators
University of Rochester · USGeorgetown University · USNorthwestern University · USParkinson's Foundation · USToronto Western Hospital · CAUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo 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).

methodsSTEADY-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.

resultsThe entire cohort of 336 participants was enrolled at 55 Parkinson Study Group sites in North America. The percentage of male participants were 68.5% with a mean age of 61.9 years (sd 9.0), mean Hoehn and Yahr stage of 1.7 (sd 0.5), mean UPDRS total of 23.1 (sd 8.6), and MoCA of 28.1 (sd 1.4).

interpretationSTEADY-PD III has a novel and innovative design allowing for the determination of longer duration benefits on clinically relevant outcomes in a relatively small cohort on top of the benefit derived from symptomatic therapy. Baseline characteristics are similar to those in previously enrolled de novo PD trials. 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.

Identifiers

PMID28589163
PMCPMC5454402
OpenAlexW2614083744

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.