A Multicenter Interventional Post-marketing Randomized Double-blind Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport ) in Comparison with OnabotulinumtoxinA (Botox ) when Treating Adults with Upper Limb Spasticity

Brief description of study

The safety and efficacy of onabotulinumtoxinA (onaBoNT-A) and abobotulinumtoxinA (aboBoNT-A) have been investigated and demonstrated in phase III trials versus placebo. However, although both products achieved alleviation of clinical symptoms of spasticity compared to placebo, their safety/efficacy has never been compared in a blinded prospective study. There is currently a lack of any multicentre, randomised, double-blind study to compare the clinical safety and efficacy of aboBoNT-A and onaBoNT-A in adult spasticity. This comparative cross-over study will aim to demonstrate the non-inferiority of aboBoNT-A versus onaBoNT-A as a primary safety endpoint, and the superiority of aboBoNT-A over onaBoNTA with respect to duration of response as the key secondary efficacy endpoint, when used at optimal doses of each product. It will provide robust evidence from the clinical setting to allow informed therapeutic decisions for care optimisation, including use of the optimal dose according to the approved product label (prescribing information).


Clinical Study Identifier: s21-01052
ClinicalTrials.gov Identifier: NCT04936542
Principal Investigator: Heidi Nicole Fusco.
Other Investigator: Steven R. Flanagan.


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