Status:
COMPLETED
Dysport® Pediatric Lower Limb Spasticity Study
Lead Sponsor:
Ipsen
Conditions:
Cerebral Palsy
Muscle Spasticity
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Fixed contracture
- Previous phenol, alcohol injection or surgical intervention
- Other neurological / neuromuscular disorder
- Severe athetoid or dystonic movements
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01249417
Start Date
July 1 2011
End Date
June 1 2014
Last Update
September 28 2022
Active Locations (29)
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1
The Children's Hospital
Aurora, Colorado, United States, 80045
2
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
3
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
4
Children's Hospital of Michigan
Detroit, Michigan, United States, 48202