Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
241 participants
INTERVENTIONAL
2011-07-31
2014-06-30
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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Dysport 10 U/Kg
10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Dysport 15 U/Kg
15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebo
Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
Placebo
I.M. injection on day 1 of a single treatment cycle.
Interventions
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Botulinum toxin type A
I.M. (in the muscle) injection on day 1 of a single treatment cycle.
Placebo
I.M. injection on day 1 of a single treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Equinus foot position
* Ambulatory
* Intensity of muscle tone equal to or greater than 2 in affected lower limb, as measured on the Modified Ashworth Scale
Exclusion Criteria
* Previous phenol, alcohol injection or surgical intervention
* Other neurological / neuromuscular disorder
* Severe athetoid or dystonic movements
2 Years
17 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Study Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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The Children's Hospital
Aurora, Colorado, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Gillette Children's Speciality Healthcare
Saint Paul, Minnesota, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Shriner's Hospital for Children
Portland, Oregon, United States
Texas Scottish Rite - Hospital for Children
Dallas, Texas, United States
Club De Leones Cruz Del Sur Rehabilitation Corporation, Punta Arenas
Punta Arenas, , Chile
Dr Roberto Del Rio Hospital
Santiago, , Chile
Neurorehabilitation Laboratory, Pontifical Catholic University
Santiago, , Chile
CHU Jean Minjoz
Besançon, , France
Hospital San José Celaya
Celaya, , Mexico
Centro de Rehabilitacion Infantil
Mexico City, , Mexico
Centro de Rehabilitacion Integral de Queretaro (CRIQ)
Querétaro, , Mexico
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosí City, , Mexico
Non-public Healthcare Unit at the Association for Disabled People KROK PO KROKU
Gdansk, , Poland
B i L- Specjalistyczne Centrum Medyczne
Lodz, , Poland
Non-public Healthcare Unit - Grunwaldzka Clinic
Poznan, , Poland
Non-public Healthcare Unit Mazovian Neurorehabilitatio
Wiązowna, , Poland
Ghulane Military Medical Academy and School of Medicine
Ankara, , Turkey (Türkiye)
Ibn-i-Sina Hospital
Ankara, , Turkey (Türkiye)
Yildirim Beyazit Training and Research Hospital
Ankara, , Turkey (Türkiye)
GATA Haydarpasa Training Hospital
Istanbul, , Turkey (Türkiye)
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastirma Hastanesi
Istanbul, , Turkey (Türkiye)
Istanbul Fizik Tedavi Rehabilitasyon
Istanbul, , Turkey (Türkiye)
Istanbul University Medical School
Istanbul, , Turkey (Türkiye)
Dokuz Eylül University Medical Faculty
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty
İzmit, , Turkey (Türkiye)
Countries
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Other Identifiers
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2009-017709-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-55-52120-141
Identifier Type: -
Identifier Source: org_study_id
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