BOTOX® Treatment in Pediatric Lower Limb Spasticity

Study ID
191622-111

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Kara Lorduy
214/456-7000
kara.jenkins@utsouthwestern.edu

Principal Investigator
Fatma Gul

Official Title

Brief Overview


This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
pediatric patients with lower limb spasticity.

Participant Eligibility


Inclusion Criteria:

- Minimum weight of 10 kg/22 lb

- Cerebral palsy with dynamic muscle contracture /spasticity of the ankle

Exclusion Criteria:

- Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
sclerosis, or mitochondrial disease

- Uncontrolled epilepsy

- Botulinum Toxin therapy of any serotype for any condition within the last 6 months

- History of surgical intervention of the lower study leg or planned surgery of any
limb during the study

- Previous casting of the study limb for spasticity within 6 months or with a dynamic
splint within 3 months, or planned casting or dynamic splinting for spasticity of the
study limb or affected upper limb during the study