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NCT04630873
Low or High Botox Dilution for the Hemiplegic Gait?
Phase 1 trial testing Botulinum toxin in Post Stroke Spastic Hemiplegia in 20 participants. Currently enrolling.
1 August 2025
Quick facts
| Lead sponsor | University of Ioannina |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 20 November 2020 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 August 2025 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Botulinum toxin — full drug profile →
- gait analysis
Conditions studied
- Post Stroke Spastic Hemiplegia — all drugs for Post Stroke Spastic Hemiplegia →
Sponsor
University of Ioannina
Who can join
18 and older, any sex, with Post Stroke Spastic Hemiplegia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There is debate regarding the efficiency of different dilutions of Botulin toxin type A (BTX-A) injections. Some authors believe that highly diluted BTX-A injections achieve greater neuromuscular blockade resulting in higher spasticity reduction. On the other hand, other researchers suggest that there is no difference in spasticity decrease if either high or low volume toxin is being injected. Studies on this subject lack either the design or the power of study was low. Therefore, there is no clear guideline for an optimal botulinum toxin dilution protocol. In an attempt to have a better understanding, a cross over study was designed. The material will be patients with spastic hemiparesis which will be treated with Botulin toxin at different dilutions. Gait analysis will be used for the evaluation of the Botulin toxin injection on gait improvement. To the best of our knowledge such a trial hasn't been performed yet.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04630873
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06080438 — Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure · Phase 4 · terminated
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Other University of Ioannina trials
Trials by the same sponsor.
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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 NCT04630873 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Ioannina
- Last refreshed: 6 December 2024
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/NCT04630873.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing