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

Ipsen45 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Participants

Interventions

Botulinum toxin type ABIOLOGICAL

Intramuscular Injection, concentration 300 units (U)

Botulinum toxin type ABIOLOGICAL

Intramuscular Injection, concentration 50 U

Botulinum toxin type ABIOLOGICAL

Intramuscular Injection, concentration 50 U

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mac Research Clinical research Unit

Manchester, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Baseline (Day 1) and Week 28

Secondary Outcomes

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

Time frame: Baseline (Day 1) and Week 40

Percentage of Participants With Recovery of CMAP Total Amplitude

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.

Time frame: At Weeks 28 and 40

Time to Onset of Action of Study Intervention

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.

Data from ClinicalTrials.gov

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