Phase 3
N=12
Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT03469999 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Oxygen Consumption (ml/kg/Min) — 14.82; 16.75; 28.77 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dysport Injectable Product (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Consumption (ml/kg/Min) |
14.82; 16.75; 28.77 | — |
| SECONDARY Gait Velocity (cm/s) |
84.86; 92.84; 87.11 | — |
| SECONDARY Muscle Spasticity Using MAS |
1.71; 1.29; 1.17; 1.71; 1.14; 1.17 | — |
| SECONDARY Muscle Spasticity Using MTS |
— | — |
| SECONDARY Score on the Cerebral Palsy Quality of Life (CP QOL) Questionnaire |
— | — |
Summary
This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.
Eligibility Criteria
Inclusion Criteria
- Age: 5-17 years. Must be 10 kilograms at screening and injection visits
- Diagnosis of spastic diplegia or mild- to moderate spastic quadriplegia Cerebral Palsy
- Gross Motor Function Classification System level: I, II, III
- Ability to ambulate independently without aid, equinus gait
- Absent of joint or bone deformities
- Eligible to receive single-event multi-level chemoneurolysis (SEMLC)
- Cooperative and tolerant to testing procedures during clinic screening
- Presence of spasticity in one or both legs
- Be on a stable dose and regimen if on any prescribed medication/s
- Parent must have signed written informed consent and the Patient Authorization for Use and Release of Health and Research Study Information
Exclusion Criteria
- Ankle contractures no more than -10 degrees with the knee extended
- Hemiplegia
- Wheelchair dependent
- Received Botulinum toxin within previous 4 months
- Uncontrolled epilepsy or certain types of seizures
- Fracture in the study limb within previous 12 months
- Infection or skin disorder at planned injection site
- Shortness of breath or other respiratory issues
- Uncontrolled clinically significant medical condition
- Received phenol or alcohol block in the study limb within previous 6 months
- Surgery in the study limb within previous 12 months
- Serial casting within previous 12 months
- New physiotherapy and/or orthotic regimen 1 month before study start and maintained throughout study)
Data sourced from ClinicalTrials.gov (NCT03469999). 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.