Dysport® Pediatric Lower Limb Spasticity Study
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 3/1/2014 |
| Start Date: | July 2011 |
| End Date: | December 2014 |
| Contact: | Ipsen Recruitment Enquiries |
| Email: | clinical.trials@ipsen.com |
A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy
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.
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.
Inclusion Criteria:
- Children aged 2 to 17 years with cerebral palsy
- Equinus foot position
- Ambulatory
- Intensity of muscle tone greater than 2 in affected lower limb, as measured on the
Modified Ashworth Scale
Exclusion Criteria:
- Fixed contracture
- Previous phenol, alcohol injection or surgical intervention
- Other neurological / neuromuscular disorder
- Severe athetoid or dystonic movements
We found this trial at
11
sites
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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