BOTOX® Treatment in Pediatric Lower Limb Spasticity

Completed · Phase 3 · Has a placebo group

Conditions studied: Pediatrics, Muscle Spasticity, Cerebral Palsy

In brief

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

Key facts

Study ID

NCT01603628

Run by

Allergan

People needed

384

Starts

2012-09-11

Expected to finish

2017-06-28

Last updated by the study team

2018-08-14

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Minimum weight of 10 kg/22 lb
• Cerebral palsy with dynamic muscle contracture /spasticity of the ankle

You may not qualify if…

• 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

Where it is running

• Harrison Clinical Management — Pomona, California, United States
• Children's Hospital Colorado Dept. of PM&R — Aurora, Colorado, United States
• Associated Neurologists of Southern CT, 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
• Rehab Institute of Chicago — Chicago, Illinois, United States
• The Children's Mercy Hospital & Clinics — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Clinical Research Center of New Jersey — Voorhees Township, New Jersey, United States
• NYU Hospital for Joint Diseases — New York, New York, United States
• Columbia University Medical Center Dept. of Rehab. & Regenerative Medicine — New York, New York, United States
• OnSite Clinical Solutions, LLC — Charlotte, North Carolina, United States
• PMG Research of Charlotte, LLC — Charlotte, North Carolina, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine Texas Children's Hospital — Houston, Texas, United States
• Road Runner Research — San Antonio, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States
• Semmelweis Egyetem- Ortopédiai Klinika — Budapest, Hungary
• AMS Neurology — Pasadena, California, United States

Full record on ClinicalTrials.gov

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