NCT04970407

A Comparative Study to Evaluate the Effects and Mechanism of Action of Dysport®, Botox® and Xeomin® in the Extensor Digitorum Brevis Model in Healthy Adult Male Participants

A Phase I, Randomised, Double-blind, Parallel-group, Single-centre Comparative Study to Evaluate the Pharmacodynamic Profile of Dysport®, Botox®, and Xeomin® in the Extensor Digitorum Brevis (EDB) Model in Healthy Adult Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Ipsen · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study aimed at comparing the pharmacodynamic profile (including duration of action) of three commercialized toxins by measuring the action potential of the injected muscle (extensor digitorum brevis)

Conditions

• Healthy Participants

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	Intramuscular Injection, concentration 300 units (U)
BIOLOGICAL	Botulinum toxin type A	Intramuscular Injection, concentration 50 U
BIOLOGICAL	Botulinum toxin type A	Intramuscular Injection, concentration 50 U

Timeline

• Start date: 2021-07-06
• Primary completion: 2022-03-16
• Completion: 2022-06-08
• First posted: 2021-07-21
• Last updated: 2025-02-19
• Results posted: 2024-08-01

Locations

1 site across 1 country: United Kingdom