BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

NCT01575054 ↗

Phase 3 Completed 468 enrolled Allergan

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.

Timeline

Start: 2012-05
Primary completion: 2014-09
Completion: 2015-07

Outcome

Met primary endpoint

paper Small improvements in MAS observed with onabotulinumtoxinA during the double-blind phase (onabotulinumtoxinA, -0.8; placebo, -0.6, P = .01) PMID 29330071 ↗

Publications

Wein T, Esquenazi A, Jost WH, Ward AB, Pan G, Dimitrova R. OnabotulinumtoxinA for the Treatment of Poststroke Distal Lower Limb Spasticity: A Randomized Trial. PM R. 2018 Jul;10(7):693-703. doi: 10.1016/j.pmrj.2017.12.006. Epub 2018 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	300 iu	Intramuscular
Subject	Botulinum toxin type A	Protein / enzyme biologic	400 iu	Intramuscular

Indications

No indication recorded.