Phase 3
N=241
Dysport® Pediatric Lower Limb Spasticity Study
Cerebral Palsy · Muscle Spasticity · Children
Bottom Line
View on ClinicalTrials.gov: NCT01249417 ↗Enrolled (actual)
241
Serious AEs
2.1%
Results posted
Feb 2017
Primary outcome: Primary: Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb — -0.86; -0.97; -0.48 units on a scale — p=0.0029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin type A (Biological); Placebo (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb |
-0.86; -0.97; -0.48 | 0.0029 sig |
| SECONDARY Physician's Global Assessment (PGA) of the Treatment Response. |
1.54; 1.5; 0.73 | <0.0001 sig |
| SECONDARY Goal Attainment Scale (GAS) Score |
51.53; 50.86; 46.21 | 0.0006 sig |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Fixed contracture
- Previous phenol, alcohol injection or surgical intervention
- Other neurological / neuromuscular disorder
- Severe athetoid or dystonic movements
Data sourced from ClinicalTrials.gov (NCT01249417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.