OBJECTIVE: To assess efficacy and safety of two dilutions of botulinum neurotoxin type A NT 201 (Xeomin®) in patients with upper limb spasticity of diverse etiology. METHODS: Changes in functional disability and muscle tone from baseline to week 4 after NT 201 treatment. RESULTS:One hundred ninety-two patients with stroke, brain injury, multiple sclerosis, or cerebral palsy were randomized to either 50 or 20 U/ml NT 201 dilutions. The maximum total NT 201 dose was 495 units. Four weeks post-injection, a ≥ 1-point reduction was observed on the Disability Assessment Scale in 57.1%, and on the Ashworth scale in ≥ 62.2% of patients. The 20 U/ml NT 201 dilution was non-inferior to the 50 U/ml NT 201 dilution. Global improvement was rated high by patients (80.2%) and investigators (89.0%). CONCLUSIONS:NT 201 improved functional disability and muscle tone and was well tolerated in patients with upper limb spasticity of diverse etiology in both dilutions.
RCT Entities:
OBJECTIVE: To assess efficacy and safety of two dilutions of botulinum neurotoxin type A NT 201 (Xeomin®) in patients with upper limb spasticity of diverse etiology. METHODS: Changes in functional disability and muscle tone from baseline to week 4 after NT 201 treatment. RESULTS: One hundred ninety-two patients with stroke, brain injury, multiple sclerosis, or cerebral palsy were randomized to either 50 or 20 U/ml NT 201 dilutions. The maximum total NT 201 dose was 495 units. Four weeks post-injection, a ≥ 1-point reduction was observed on the Disability Assessment Scale in 57.1%, and on the Ashworth scale in ≥ 62.2% of patients. The 20 U/ml NT 201 dilution was non-inferior to the 50 U/ml NT 201 dilution. Global improvement was rated high by patients (80.2%) and investigators (89.0%). CONCLUSIONS: NT 201 improved functional disability and muscle tone and was well tolerated in patients with upper limb spasticity of diverse etiology in both dilutions.
Authors: Dirk Dressler; Roongroj Bhidayasiri; Saeed Bohlega; Abderrahmane Chahidi; Tae Mo Chung; Markus Ebke; L Jorge Jacinto; Ryuji Kaji; Serdar Koçer; Petr Kanovsky; Federico Micheli; Olga Orlova; Sebastian Paus; Zvezdan Pirtosek; Maja Relja; Raymond L Rosales; José Alberto Sagástegui-Rodríguez; Paul W Schoenle; Gholam Ali Shahidi; Sofia Timerbaeva; Uwe Walter; Fereshte Adib Saberi Journal: J Neurol Date: 2016-10-27 Impact factor: 4.849
Authors: Wolfgang H Jost; Reiner Benecke; Dieter Hauschke; Joseph Jankovic; Petr Kaňovský; Peter Roggenkämper; David M Simpson; Cynthia L Comella Journal: Drug Des Devel Ther Date: 2015-04-01 Impact factor: 4.162
Authors: Elie Paul Elovic; Michael C Munin; Petr Kaňovský; Angelika Hanschmann; Reinhard Hiersemenzel; Christina Marciniak Journal: Muscle Nerve Date: 2015-12-15 Impact factor: 3.217