drugset / Trial / NCT04936542
A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.
Timeline
- Start
- 2021-06-23
- Primary completion
- 2025-08-26
- Completion
- 2025-08-26
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper Adjusted rate of TEAEs for aboBoNT-A (20.3%) was non-inferior to onaBoNT-A (23.0%); PMID 42159955 ↗
paper Adjusted difference (aboBoNT-A - onaBoNT-A) was -2.7% (80%CI -6.2%, 0.9%). PMID 42159955 ↗
Publications
- Esquenazi A, Wein TH, Verduzco-Gutierrez M, Ayyoub Z, Page S, Harding S, Maisonobe P, Beneteau M, Patel A; DIRECTION study group. A Phase IV, Randomized, Double-Blind, Crossover Study to Compare the Clinical Safety and Efficacy of AbobotulinumtoxinA and OnabotulinumtoxinA in Adult Upper Limb Spasticity. Adv Ther. 2026 May 20. doi: 10.1007/s12325-026-03635-y. Online ahead of print.
- Esquenazi A, Ayyoub Z, Verduzco-Gutierrez M, Maisonobe P, Otto J, Patel AT. AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol. Adv Ther. 2021 Nov;38(11):5623-5633. doi: 10.1007/s12325-021-01896-3. Epub 2021 Sep 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | abobotulinumtoxinA | Protein / enzyme biologic | 900 iu | Intramuscular |
| Subject | onaBoNT-A | Protein / enzyme biologic | 360 iu | Intramuscular |
Indications
No indication recorded.