This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. Safety population included all treated participants.
Time frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
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ABS Health, LLC
Pasadena, California, United States
Harrison Clinical Management
Pomona, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Children's Hospital Colorado Dept. of PM&R
Aurora, Colorado, United States
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, United States
New England Center for Clinical Research
Stamford, Connecticut, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, United States
Pediatric Neurology, PA
Orlando, Florida, United States
Children's Healthcare of Atlanta Children's Rehabilitation Associates
Atlanta, Georgia, United States
...and 38 more locations