Clinical trial NCT04970407: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28
timeFrame: Baseline (Day 1) and Week 28
Secondary outcomes:
measure: Change From Baseline in AM % of CMAP Total Amplitude at Week 40
timeFrame: Baseline (Day 1) and Week 40
measure: Percentage of Participants With Recovery of CMAP Total Amplitude
timeFrame: At Weeks 28 and 40
measure: Time to Onset of Action of Study Intervention
timeFrame: From Baseline (Day 1) up to Week 40
measure: Duration of Response
timeFrame: From Baseline (Day 1) up to Week 40
measure: Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude
timeFrame: Up to Week 40
measure: Number of Participants Who Achieved Maximal Effect of CMAP Total Amplitude
timeFrame: At Weeks 1, 4, 8 and 20
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Mac Research Clinical research Unit
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: