BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study - Rehabilitation Institute of Chicago

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BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study

Objective

The purpose of this study is to investigate how safe and well BOTOX® (Botulinum toxin type A) works in the treatment of children with muscle stiffness of the ankle and foot.
BOTOX® is marketed in the United States for upper limb spasticity in adults, but not for children. Therefore, for the purposes of this study, this medication is considered investigational, meaning that it has not been approved by the FDA for upper limb spasticity in children. This study will assess the safety and effectiveness of BOTOX® in treating pediatric lower limb spasticity.

IRB Protocol Number
STU00069841
Principal Investigator(s)
Shubhra Mukherjee

Clinical Trial Categories

  • Brain Injury Research
  • Cerebral Palsy - Pediatrics Research
  • Pediatrics Research

Compensation

  • Provided
Contact
Meredith Rathert at 312-238-2412
or mrathert@ric.org
Who Can Participate
  • Children between ages of 2-16
  • Diagnosis of CP
  • GMFCS level I to IV at the screening visit
  • Has family commitment to comply with protocol-required procedures including weekly standardized PT sessions throughout the study