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

Healthy Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970407
• Other study ID #: D-FR-52120-279
• Secondary ID: 2021-000802-14
• Status: Completed
• Phase: Phase 1
• Start date: July 6, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: August 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 8, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Biological:
• Botulinum toxin type A
Intramuscular Injection, concentration 300 units (U)
• Botulinum toxin type A
Intramuscular Injection, concentration 50 U
• Botulinum toxin type A
Intramuscular Injection, concentration 50 U

Locations

Country	Name	City	State
United Kingdom	Mac Research Clinical research Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMAP total amplitude measured as relative change from Baseline (%)		week 28.
Secondary	CMAP total amplitude measured as relative change from Baseline (%).		Week 40.
Secondary	Incidence of recovery of CMAP total amplitude, defined as total amplitude return to at least 85% of the Baseline value.		Week 28.
Secondary	Incidence of recovery of CMAP total amplitude.		Week 40.
Secondary	Time to onset of action defined as first timepoint where EDB CMAP total amplitude is 85% or lower than the Baseline value.		From baseline to week 40.
Secondary	Duration of response defined as time period between time to onset and time to recovery.	Time to recovery is defined as the first timepoint (post time to onset of action and assuming that % of baseline value keeps on decreasing) where EDB CMAP total amplitude returns to at least 85% of the baseline value.	From baseline to week 40.
Secondary	Maximal inhibition (maximal effect) reached.	Maximal Effect for each participant is defined as the maximal measured inhibition of CMAP amplitude of stimulated EDB. Maximal Effect will be analysed descriptively.	From baseline to week 40.
Secondary	Time to maximal effect on the CMAP total amplitude of stimulated EDB.		From baseline to week 40.
Secondary	Type, incidence and severity of TEAEs, SAEs, AEs (or SAEs) leading to withdrawals		From baseline to week 40.