Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 10/25/2018 |
| Start Date: | April 2014 |
| End Date: | September 4, 2018 |
A Phase III, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT® Used In The Treatment Of Upper Limb Spasticity In Children
The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport
used in the treatment of upper limb spasticity (altered skeletal muscle performance) in
children with cerebral palsy (CP).
used in the treatment of upper limb spasticity (altered skeletal muscle performance) in
children with cerebral palsy (CP).
Inclusion Criteria:
- Upper limb spasticity due to cerebral palsy
- Body weight 10 kg or over
- MAS score of 2 or more in affected elbow or wrist flexors
Exclusion Criteria:
- Fixed myocontracture
- Previous phenol or alcohol injection within 1 year
- Severe athetoid or dystonic movements
- Previous or planned surgery for spasticity in elbow or wrist flexors
- Neuromuscular disorders
- Previous Rhizotomy within 6 months
- Intrathecal baclofen within 30 days
We found this trial at
13
sites
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