Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2012-07-12
2017-07-06
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® 3 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 units (U) per kilogram (kg) of body weight (3 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
botulinum toxin Type A
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
BOTOX® 6 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
botulinum toxin Type A
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
Placebo
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
Normal Saline (Placebo)
Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.
Interventions
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botulinum toxin Type A
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
Normal Saline (Placebo)
Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Upper limb spasticity due to cerebral palsy or stroke
Exclusion Criteria
* 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
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
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
Specjal. Gabinet Neurologiczny
Krakow, , Poland
Centrum Medyczne "POMOC"
Lodz, , Poland
INTERMED, Lublin
Lublin, , Poland
CRH ŻAGIEL MED, Lublin
Lublin, , 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
Goyang-si, , 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
Siriraj Hospital, Mahidol University
Bangkok, , Thailand
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)
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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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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2012-000062-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
191622-101
Identifier Type: -
Identifier Source: org_study_id
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