A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
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Phase
Phase 4
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
464actual
Sites
76
Countries
Canada, France, Puerto Rico +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-06-23 | actual | When the study began enrolling |
| Primary completion | 2025-08-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-08-26 | actual | The whole study's end, after follow-up |
| First posted | 2021-06-23 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-09 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Upper Limb Spasticity
Interventions
- Biological: AboBoNT-A — also filed as Dysport®
- Biological: OnaBoNT-A — also filed as Botox®
Primary outcome
what the primary-completion date above is the date OFPercentage of Participants With Treatment-Emergent Adverse Events (TEAEs) From Injection to 12 Weeks
measured From Baseline (Injection: Day 1) up to 12 weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2025-01-13 · 5.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-09-23 · 6.7 MB · SAP_001.pdf
Publications
- PMID 42159955 — linked by the registry
- PMID 34562231 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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