Efficacy and safety of NT 201 for upper limb spasticity of various etiologies--a randomized parallel-group study.
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.
Barnes
M
M
14 Rake House Farm, North Shields, UK. m.p.barnes@btinternet.com
Schnitzler
A
A
Medeiros
L
L
Aguilar
M
M
Lehnert-Batar
A
A
Minnasch
P
P
D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D001930:Brain Injuries / Q000150:complications / Q000503:physiopathology; D002547:Cerebral Palsy / Q000150:complications / Q000503:physiopathology; D005260:Female; D006406:Hematoma / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000503:physiopathology; D009128:Muscle Spasticity / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D018908:Muscle Weakness / Q000209:etiology; D011446:Prospective Studies; D020521:Stroke / Q000150:complications / Q000503:physiopathology; D016896:Treatment Outcome; D034941:Upper Extremity / Q000503:physiopathology*
D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA