Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke

Summary

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

Timeline

Start

2011-12

Primary completion

2014-08

Completion

2015-05

Outcome

Missed primary endpoint

registry IncobotulinumtoxinA (Xeomin) 400 Units vs Placebo; p = 0.777 NCT01464307 ↗

registry IncobotulinumtoxinA (Xeomin) 400 Units vs Placebo; p = 0.804 NCT01464307 ↗

Drugs

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

Indications