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 Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2022-06-08

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dysport®

40 Units (U) Intramuscular (IM) injection at day 1.

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type BIOLOGICAL

Intramuscular Injection, concentration 300 units (U)

Botox®

16U IM at day 1.

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type BIOLOGICAL

Intramuscular Injection, concentration 50 U

Xeomin®

16U IM at day 1.

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type BIOLOGICAL

Intramuscular Injection, concentration 50 U

Interventions

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Botulinum toxin type A

Intramuscular Injection, concentration 300 units (U)

Intervention Type BIOLOGICAL

Botulinum toxin type A

Intramuscular Injection, concentration 50 U

Intervention Type BIOLOGICAL

Botulinum toxin type A

Intramuscular Injection, concentration 50 U

Intervention Type BIOLOGICAL

Other Intervention Names

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abobotulinumtoxinA (Dysport®) onabotulinumtoxinA (Botox®) incobotulinumtoxinA (Xeomin®)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes