BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
NCT ID: NCT01603641
Last Updated: 2019-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2012-11-05
2018-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BOTOX®
Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
Botulinum Toxin Type A
Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Interventions
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Botulinum Toxin Type A
Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cerebral palsy with dynamic muscle contracture of the ankle
Exclusion Criteria
* 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
2 Years
17 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Emily McCusker
Role: STUDY_DIRECTOR
Allergan
Locations
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ABS Health, LLC
Pasadena, California, United States
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
Marshfield Clinic
Marshfield, Wisconsin, United States
Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27
Budapest, , Hungary
Debrecen University Clinical Center, Orthopedic Clinic
Debrecen, , Hungary
Istituto IRCCS G. Salini
Genoa, , Italy
Philippine Orthopedic Center
Quezon City, , Philippines
St. Luke's Medical Center
Quezon City, , Philippines
Philippine Children's Medical Center
Quezon City, , Philippines
Uniwersytecki Dzieciecy Szpita
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Centrum Rehabilitacji Krok po Kroku
Gdansk, , Poland
Specjalistyczny Gabinet Neurologiczny
Krakow, , Poland
Centrum Medyczne "POMOC"
Lodz, , Poland
INTERMED, Lublin
Lublin, , Poland
CRH ŻAGIEL MED, Lublin
Lublin, , Poland
Szpital Wojewodzki Nr 2
Rzeszów, , Poland
Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga
Warsaw, , Poland
NZOZ Mazowieckie Centrum
Warsaw, , Poland
Childrens Republic Hospital
Kazan', , Russia
Smolensk Regional Hospital- Regional Budget State Healthcare institution
Smolensk, , Russia
Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
Tyumen, , Russia
Daegu Fatima Hospital
Daegu, , South Korea
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, , Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, , Thailand
Ankara Diskapi Yildrim Beyazit
Ankara, , Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli, , Turkey (Türkiye)
Selçuk Üniversitesi
Konya, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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More information
Other Identifiers
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2012-000084-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
191622-112
Identifier Type: -
Identifier Source: org_study_id
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