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

Ipsen

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04970407

D-FR-52120-279

2021-000802-14 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 45 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Dysport®

Experimental group

Description:

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

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Botox®

Active Comparator group

Description:

16U IM at day 1.

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Xeomin®

Active Comparator group

Description:

16U IM at day 1.

Treatment:

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A

Biological: Botulinum toxin type A