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A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.

NCT04936542 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2025-11-19

No results posted yet for this study

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

  • Upper Limb Spasticity

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2025-08-26
Completion
2025-08-26
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04936542 on ClinicalTrials.gov