Merz Neurosciences announced that data from its phase 3 NT 201 clinical trial for incobotulinumtoxin A will be published in the medical journal Muscle & Nerve.
The Post-stroke Spasticity Upper Limb Study to Investigate Efficacy and Safety (PURE) of NT 201, met both of its primary endpoints, according to a press release.
The company has submitted a supplemental Biologics License Application to the FDA seeking approval to use incobotulinumtoxin A in the treatment of post-stroke limb spasticity.
Muscle tone improved, defined as a change in Ashworth Scale score from baseline to week 4 along with improvements in functional outcomes, defined as investigator’s Global Impression of Change at the week 4 visit.
Both scores showed statistically significance.
Adverse events were reported for 3.8% of patients receiving incobotulinumtoxin A and for 1.9% of patients receiving placebo.