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Completed

NCT Number: 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

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)

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Key information

Conditions

Healthy Participants

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mac Research Clinical research Unit

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must be between18 to 65 years of age inclusive, at the time of signing the informed consent
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring
  • A body mass index (BMI) within the range 18 and 30 kg/m2 (inclusive).

Exclusion criteria

  • Any medical condition that may put the participant at risk with exposure to BoNT, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
  • Previous treatment with botulinum toxin (BoNT) (any serotype) during the past 6 months
  • Known hypersensitivity to any of the components of the Dysport/ Botox/ Xeomin formulation (which includes human serum albumin, lactose, sucrose) or allergy to cow's milk protein
  • Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine

Treatment and study plan

Botulinum toxin type A

Biological

Intramuscular Injection, concentration 300 units (U)

Other names: abobotulinumtoxinA (Dysport®)

Primary outcomes

  1. Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28

    Time frame: Baseline (Day 1) and Week 28

    The CMAP procedure was performed on the injected foot by a neurophysiologist. Percentage relative to baseline was calculated as (value at Week 28 [mean of the 3 measurements]/baseline value) multiplied by (*) 100. The adjusted mean was obtained from a mixed-effects model for repeated measures (MMRM) model with Fisher scoring. Baseline was defined as the last non-missing measurement taken prior to study drug administration. Baseline value used for this analysis was the average of 6 measurements, the 3 measurements at screening and the 3 measurements at baseline.

Secondary outcomes

  1. Change From Baseline in AM % of CMAP Total Amplitude at Week 40

    Time frame: Baseline (Day 1) and Week 40

    The CMAP procedure was performed on the injected foot by a neurophysiologist. It was measured as percentage relative to baseline defined as CMAP at the corresponding visit (mean of the 3 measurements)/CMAP at baseline (mean of the 6 measurements)*100. The adjusted mean was obtained from a MMRM model with Fisher scoring. Baseline was defined as the last non-missing measurement taken prior to study drug administration. Baseline value used for this analysis was the average of 6 measurements, the 3 measurements at screening and the 3 measurements at baseline.

  2. Percentage of Participants With Recovery of CMAP Total Amplitude

    Time frame: At Weeks 28 and 40

    The recovery was considered to be reached for all the visits occurring after the time to recovery, that is (i.e.) the first visit for which CMAP total amplitude returned to at least 85% of the baseline value. Percentage of participants with recovery of CMAP total amplitude was analyzed at Weeks 28 and 40.

  3. Time to Onset of Action of Study Intervention

    Time frame: From Baseline (Day 1) up to Week 40

    Time to onset of action was defined as the first timepoint when EDB CMAP total amplitude was less or equal to 85% of the baseline value.

  4. Duration of Response

    Time frame: From Baseline (Day 1) up to Week 40

    Duration of response was calculated as time to recovery of CMAP total amplitude - time to onset. Time to recovery was defined as the first timepoint where EDB CMAP total amplitude returned to at least 85% of the baseline value.

  5. Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude

    Time frame: Up to Week 40

    Maximal inhibition was defined as the maximal measured inhibition of CMAP total amplitude of stimulated EDB.

  6. Number of Participants Who Achieved Maximal Effect of CMAP Total Amplitude

    Time frame: At Weeks 1, 4, 8 and 20

    Time to maximal effect was defined on an individual basis as the time between baseline and the timepoint of maximal inhibition of CMAP amplitude of stimulated EDB. Participants with maximal effect of CMAP total amplitude were reported.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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