BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

Completed · Phase 3

Conditions studied: Pediatrics, Muscle Spasticity, Cerebral Palsy

In brief

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.

Key facts

Study ID

NCT01603641

Run by

Allergan

People needed

370

Starts

2012-11-05

Expected to finish

2018-08-25

Last updated by the study team

2019-08-21

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Minimum weight of 10 kilograms (kg)/22 pounds (lb)
• Cerebral palsy with dynamic muscle contracture 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 3 months
• History of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study

Where it is running

• Harrison Clinical Management — Pomona, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Associated Neurologists of Southern Connecticut, P.C. — Fairfield, Connecticut, United States
• New England Institute 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, P.A. — Orlando, Florida, United States
• Children's Healthcare of Atlanta Children's Rehabilitation Associates — Atlanta, Georgia, United States
• Shirley Ryan Ability Lab — Chicago, Illinois, United States
• Beaumont Children's Hospital Pediatric Research — Royal Oak, Michigan, United States
• The Children's Mercy Hospital — 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 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
• Hasbro Children's 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
• ABS Health, LLC — Pasadena, California, United States

Full record on ClinicalTrials.gov

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