Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy

• Status: Completed
• Trial end date: 2021-05-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Age: 5-17 years. Must be <18 prior to injection.

• >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. (physiotherapy and/or orthotic regimen will be permitted if it began >1 month before study start and maintained throughout study)