Trials / Completed
CompletedNCT04936542
A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison With OnabotulinumtoxinA (Botox®) When Treating Adults With Upper Limb Spasticity
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 464 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AboBoNT-A | AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL) |
| BIOLOGICAL | OnaBoNT-A | OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL) |
Timeline
- Start date
- 2021-06-23
- Primary completion
- 2025-08-26
- Completion
- 2025-08-26
- First posted
- 2021-06-23
- Last updated
- 2025-11-19
Locations
76 sites across 4 countries: United States, Canada, France, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04936542. Inclusion in this directory is not an endorsement.