Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
384 participants
INTERVENTIONAL
2012-09-11
2017-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BOTOX® 4 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).
botulinum toxin Type A
Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.
BOTOX® 8 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
botulinum toxin Type A
Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.
Normal Saline (Placebo)
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1. Participants received weekly PT.
Normal Saline (Placebo)
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.
Interventions
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botulinum toxin Type A
Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.
Normal Saline (Placebo)
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cerebral palsy with dynamic muscle contracture /spasticity of the ankle
Exclusion Criteria
* 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
2 Years
16 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Rozalina Dimitrova
Role: STUDY_DIRECTOR
Allergan
Locations
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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
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
Debrecen University Clinical Center, Orthopedic Clinic
Debrecen, , Hungary
Istituto IRCCS G. Gaslini
Genoa, , Italy
Philippine Orthopedic Center
Quezon City, , Philippines
St. Luke's Medical Center-Quezon City
Quezon City, , Philippines
Philippine Children's Medical Center
Quezon City, , Philippines
Uniwersytecki Dzieciecy Szpita
Bialystok, , Poland
Uni Centrum Kliniczne
Gdansk, , Poland
Centrum Rehabilitacji Krok po Kroku
Gdansk, , Poland
Specjal. Gabinet Neurologiczny
Krakow, , Poland
INTERMED, Lublin
Lublin, , Poland
CRH ŻAGIEL MED, Lublin
Lublin, , Poland
Szpital Wojewódzki Nr 2
Rzeszów, , Poland
Neuro - 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
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.
Other Identifiers
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2012-000042-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
191622-111
Identifier Type: -
Identifier Source: org_study_id
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