Phase 1
Completed N=45
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
Source: ClinicalTrials.gov NCT04970407 ↗
Enrolled (actual)
45
Serious AEs
37.8%
Results posted
Aug 2024
Primary outcomePrimary: Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28 — 73.62; 74.78; 84.23 % of AM of CMAP total amplitude — p=0.8769
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Adjusted Mean (AM) Percentage (%) of CMAP Total Amplitude at Week 28 |
73.62; 74.78; 84.23 | 0.8769 |
| SECONDARY Change From Baseline in AM % of CMAP Total Amplitude at Week 40 |
77.10; 81.83; 92.01 | — |
| SECONDARY Percentage of Participants With Recovery of CMAP Total Amplitude |
33.3; 26.7; 53.3; 33.3; 33.3; 66.7 | — |
| SECONDARY Time to Onset of Action of Study Intervention |
1.00; 1.00; 1.00 | — |
| SECONDARY Duration of Response |
18.29; 10.86; 17.07 | — |
| SECONDARY Percentage of Maximal Inhibition (Maximal Effect) of CMAP Total Amplitude |
39.79; 38.55; 44.99 | — |
| SECONDARY Number of Participants Who Achieved Maximal Effect of CMAP Total Amplitude |
11; 13; 11; 2; 1; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT04970407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.