This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale
Time frame: Baseline, Up to 60 Weeks
Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
Time frame: Baseline, Up to 60 Weeks
Change from Baseline in Pain on an 11-Point Scale
Time frame: Baseline, Up to 60 Weeks
Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score
Time frame: Baseline, Up to 60 Weeks
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