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.

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

sites

Cincinnati Children's Hospital Medical Center

3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229

1-513-636-4200