Dysport® Pediatric Lower Limb Spasticity Study
Completed · Phase 3 · Has a placebo group
Conditions studied: Cerebral Palsy, Muscle Spasticity, Children
In brief
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.
Key facts
- Study ID
- NCT01249417
- Run by
- Ipsen
- People needed
- 241
- Starts
- 2011-07-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2022-09-28
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children aged 2 to 17 years with cerebral palsy
- 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
You may not qualify if…
- Fixed contracture
- Previous phenol, alcohol injection or surgical intervention
- Other neurological / neuromuscular disorder
- Severe athetoid or dystonic movements
Where it is running
- 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)
Full record on ClinicalTrials.gov
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