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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

NCT04970407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-02-19

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2022-03-16
Completion
2022-06-08

Countries

  • United Kingdom

Study Locations

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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 NCT04970407 on ClinicalTrials.gov