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 | Completed Phase 1 Results

• 2 other identifiers: D-FR-52120-2792021-000802-14
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1) and Week 28

Secondary Outcomes (6)

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

  Baseline (Day 1) and Week 40

• Percentage of Participants With Recovery of CMAP Total Amplitude

  At Weeks 28 and 40

• Time to Onset of Action of Study Intervention

  From Baseline (Day 1) up to Week 40

• Duration of Response

  From Baseline (Day 1) up to Week 40

• Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude

  Up to Week 40

Study Arms (3)

Dysport®

EXPERIMENTAL

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

Biological: Botulinum toxin type A

Botox®

ACTIVE COMPARATOR

16U IM at day 1.

Biological: Botulinum toxin type A

Xeomin®

ACTIVE COMPARATOR

16U IM at day 1.

Biological: Botulinum toxin type A

Interventions

Botulinum toxin type A BIOLOGICAL

Intramuscular Injection, concentration 300 units (U)

Also known as: abobotulinumtoxinA (Dysport®)

Dysport®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Mac Research Clinical research Unit

Manchester, United Kingdom

Location

Related Links

• Lay language results summary

MeSH Terms

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Laurent Pons/Clinical Pharmacology Director
• Organization: Ipsen Innovation

clinical.trials@ipsen.com

see email

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 21, 2021
• Study Start: July 6, 2021
• Primary Completion: March 16, 2022
• Study Completion: June 8, 2022
• Last Updated: February 19, 2025
• Results First Posted: August 1, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)