CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 464 enrolled
Drug / intervention
AboBoNT-A +1 morebiological
Likely dose
AboBoNT-A 500 Unitfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04936542
NCT04936542Phase 4Completed
CompareCT.gov

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

Ipsen·interventional·Posted Jun 23, 2021·Updated Nov 19, 2025

In Brief

A Phase 4 clinical trial evaluating AboBoNT-A and OnaBoNT-A for Upper Limb Spasticity. Completed, enrolled 464 participants across 76 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUpper Limb Spasticity
CountriesCanada, France, Puerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedJun 23, 2021
Enrollment StartJun 23, 2021
Primary CompletionAug 26, 2025
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 5.0 years ago

Interventions

AboBoNT-Abiological

AbobotulinumtoxinA for injection: 500 Unit vial. Dose: 900 Units (3.6 mL)

OnaBoNT-Abiological

OnabotulinumtoxinA for injection: 200 Unit vial. Dose: 360 Units (3.6 mL)