Content » Vol 43, Issue 6

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

Petr Kaňovský, Jaroslaw Slawek , Zoltán Denes , Thomas Platz , Georg Comes, Susanne Grafe , Irena Pulte
DOI: 10.2340/16501977-0796

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.

Lay Abstract

Comments

Do you want to comment on this paper? The comments will show up here and if appropriate the comments will also separately be forwarded to the authors. You need to login/create an account to comment on articles. Click here to login/create an account.
Advertisement