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NCT04404868: BTX_ST-ITA14

Early Treatment of Post-stroke Spasticity With Botulinum Toxin

Completed Last updated 28 May 2020
What this trial tests

trial testing Normal clinical practice in Stroke in 86 participants. Completed in 31 December 2018.

Timeline
27 July 2015
Primary endpoint
31 December 2018
31 December 2018

Quick facts

Lead sponsorUniversita di Verona
StatusCompleted
Study typeOBSERVATIONAL
Enrollment86
Start date27 July 2015
Primary completion31 December 2018
Estimated completion31 December 2018
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Universita di Verona — full company profile →

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This was a multicentric observational study with the aim to evaluate the effect of early treatment with botulinum toxin type A (BoNT-A) on post-stroke spasticity in adult patients. All patients enrolled (86 patients) after a baseline clinical assessment (modified Ashworth scale, motricity index, Fughl Meyer assessment and modified Rankin' scale) undergoes to a BoNT-A injection following the evidence-based clinical practice. Subsequently, at 4, 12 and 24 weeks they underwent the same clinical evaluation as a follow-up. Results are under statistical evaluation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Early Botulinum Toxin Type A Injection for Post-Stroke Spasticity: A Longitudinal Cohort Study.
    Picelli A, Santamato A, Cosma M, Baricich A, et al · · 2021 · cited 27× · PMID 34073918 · DOI 10.3390/toxins13060374
  2. Early Botulinum Toxin Type A Injection May Improve Motor Recovery in Patients with Post-Stroke Spasticity: A Secondary Analysis from a Longitudinal Cohort Study.
    Picelli A, Santamato A, Cosma M, Baricich A, et al · · 2025 · PMID 41295873 · DOI 10.3390/toxins17110558

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Other recruiting trials for Stroke

Currently open trials in the same condition.

Other Universita di Verona trials

Trials by the same sponsor.

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