drugset / 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
RandomizedParallel-groupTriple-blindTreatment
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)
Timeline
- Start
- 2021-07-06
- Primary completion
- 2022-03-16
- Completion
- 2022-06-08
Outcome
Missed primary endpoint
registry analysis (superiority test); Dysport 40 U vs Botox 16 U; p = 0.8769; Treatment difference -1.16 (95% CI -16.25 to 13.93); MMRM model NCT04970407 ↗
registry analysis (superiority test); Dysport 40 U vs Xeomin 16 U; p = 0.1620; Treatment difference -10.61 (95% CI -25.69 to 4.47); MMRM model NCT04970407 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 16 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 40 iu | Intramuscular |
Indications
No indication recorded.