You are not logged in. Press here to login.

Content

List volumes - List articles in this issue

Original report

Efficacy and safety of treatment with Incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in post-stroke upper limb spasticity

doi: 10.2340/16501977-0796

Open access

Abstract:

OBJECTIVE: To investigate the efficacy and safety of repeated treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in post-stroke upper limb spasticity.
Patients and design: After completing a double-blind, placebo-
controlled, multicentre study (up to 20 weeks), 145 patients received up to 5 additional sets of NT 201 injections for an open-label extension period of up to 69 weeks.
METHODS: Upper limb muscle groups were treated as clinically indicated; injection intervals were ≥ 12 weeks. Outcome was assessed 4 weeks after each injection session and at the end of the study.
RESULTS: Muscle tone (flexors of wrist, elbow, finger, and thumb, and forearm pronators) improved throughout the study (response rate: up to 80.6%, p < 0.0001, Ashworth Scale). Continuous and significant improvements were also observed in disability (p < 0.05, Disability Assessment Scale). The majority of investigators, patients and caregivers
rated NT 201 efficacy as very good or good (56–84%).
Adverse events considered treatment-related occurred in 11% of patients. Formation of neutralizing antibodies was not
observed in any patient after repeated treatments.
CONCLUSION: Treatment with NT 201 showed sustained
improvements in muscle tone and functionality (median dose 400 units) over a study duration of up to 89 weeks, and was well tolerated during repeated treatments for post-stroke upper limb spasticity.

Authors:

Petr Kaňovský, Jaroslaw Slawek , Zoltán Denes , Thomas Platz , Georg Comes, Susanne Grafe , Irena Pulte



Related articles

There are no related articles.


Actions


Abstract

PDF

Supplementary


There is no supplementary for this article.

Related articles


Click here to show related articles

Print information


Volume 43, Issue 6

DOI: 10.2340/16501977-0796

Pages: 486-492

View at PubMed