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NCT04404868: BTX_ST-ITA14
Early Treatment of Post-stroke Spasticity With Botulinum Toxin
trial testing Normal clinical practice in Stroke in 86 participants. Completed in 31 December 2018.
31 December 2018
Quick facts
| Lead sponsor | Universita di Verona |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 86 |
| Start date | 27 July 2015 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Normal clinical practice
Conditions studied
- Stroke — all drugs for Stroke →
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):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT04404868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Universita di Verona trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04404868 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universita di Verona
- Last refreshed: 28 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04404868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing