Evidence map›Paper›PMID 32227247›Full record

Trial reportAnnals of internal medicine2020

Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial.

Parkinson Study Group STEADY-PD III Investigators

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of internal medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02168842 (Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease), which is not on this map. Cited by 108 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 4 pooled it
10.8field-weighted citation impact, top 1% 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.

NCT02168842 phase3completednot on this map

Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease

TypeinterventionalSponsorUniversity of RochesterRan2014 to 2018Enrolled336ConditionsParkinson DiseaseArmsIsradipine, Placebo (for Isradipine)
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 4 syntheses or guidelines pooled it, 182 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Interventions for preventing falls in Parkinson's disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
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  14. Review
  15. Article
  16. Article
  17. Article
  18. Feasibility of Simon Two-Stage Futility Trials in People with Early, Symptomatically Treated Parkinson's Disease.Movement disorders : official journal of the Movement Disorder Society · 2026
    Article
  19. Article
  20. Review

48 more citing papers are in PubMed but not listed here.

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

1 author.

Parkinson Study Group STEADY-PD III Investigators

Funding

Clinical Coordination Center for STEADY-PD3U01NS080818 · NINDS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI SIMUNI, TANYA · 2014 to 2018
$13.0M
Data Coordination Center for STEADY-PD3U01NS080840 · NINDS · UNIVERSITY OF ROCHESTER · PI HOLLOWAY, ROBERT G. · 2014 to 2018
$8.6M
NINDS NIH HHS U01 NS080818NINDS NIH HHS U01 NS080840
6 · The paper itself

Abstract

Background: Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinson disease (PD). Objective: To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD. Design: Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842). Setting: 57 Parkinson Study Group sites in North America. Participants: Patients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment. Intervention: 5 mg of immediate-release isradipine twice daily or placebo for 36 months. Measurements: The primary outcome was change in the Unified Parkinson's Disease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication "ON" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures. Results: 336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study. Adjusted least-squares mean changes in total UPDRS score in the antiparkinson medication ON state over 36 months for isradipine and placebo recipients were 2.99 (95% CI, 0.95 to 5.03) points versus 3.26 (CI, 1.25 to 5.26) points, respectively, with a treatment effect of -0.27 (CI, -3.02 to 2.48) point (P = 0.85). Statistical adjustment for antiparkinson medication use did not change the findings. Secondary outcomes showed no effect of isradipine treatment. The most common adverse effects of isradipine were edema and dizziness. Limitation: The isradipine dose may have been insufficient to engage the target calcium channels associated with neuroprotective effects. Conclusion: Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD. Primary Funding Source: National Institute of Neurological Disorders and Stroke.

Indexed as

Antiparkinson AgentsCalcium Channel BlockersDisability EvaluationDisease ProgressionDouble-Blind MethodFemaleHumansIsradipineMaleMiddle AgedParkinson DiseaseSeverity of Illness IndexAntiparkinson AgentsCalcium Channel BlockersIsradipine

Identifiers

PMID32227247
PMCPMC7465126
OpenAlexW3087694789

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.