BOTOX® Treatment in Pediatric Upper Limb Spasticity

Completed · Phase 3 · Has a placebo group

Conditions studied: Pediatrics, Muscle Spasticity, Cerebral Palsy, Stroke

In brief

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

Key facts

Study ID

NCT01603602

Run by

Allergan

People needed

235

Starts

2012-07-12

Expected to finish

2017-07-06

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
• Upper limb spasticity due to cerebral palsy or stroke

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
• Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study 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 lower limb during the study

Where it is running

• AMS Neurology — Pasadena, California, United States
• 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
• 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
• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, 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 if Charlotte, LLC — Charlotte, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, 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
• Holland Bloorview Kids Rehab — Toronto, Ontario, Canada
• Debrecen University Clinical Center, Orthopedic Clinic — Debrecen, Hungary
• De La Salle University Medical Center — Dasmariñas, Cavite, Philippines
• Philippine Children's Medical Center — Bagong Pag-asa, Quezon City, Philippines
• Uni Centrum Kliniczne — Gdansk, Poland

Full record on ClinicalTrials.gov

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