Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Johns Hopkins University
Summary
This study evaluates the combined effect of botulinum toxin A (administered as Dysport® (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two thirds of patients will be treated with Dysport® and bracing, while the remaining patients will be treated with placebo and bracing.
Description
Adolescent idiopathic scoliosis (AIS) is lateral curvature of the spine with an unknown cause in children 10-16 years old. Without treatment, skeletally immature children with idiopathic curves of 20°-40° risk curve progression. Treatment of these patients is focused on either observation or bracing. Although bracing has been shown to be more effective than observation, success is contingent on patient adherence and has the potential for further optimization with adjunct therapies. Little research is available concerning adjunct therapies that may be used during bracing of AIS patients. One t…
Eligibility
- Age range
- 10–16 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Clinically determined idiopathic nature of scoliosis * Age 10-16 years * Risser stage 0,1,or 2 * major curve of 20°-40° * curve apex caudal to T7 vertebra * ability to adhere to bracing protocol * Botulinum toxin naïve or previously treated greater than 6 months prior to study entry Exclusion criteria: * Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other "reason" for scoliosis - Previous surgery at any segment of the spine * Current need for surgery at any level of the spine * Treatment with any drug known to interfere with neuromuscular function * An…
Interventions
- DrugAbobotulinumtoxinA
Paraspinal abobotulinumtoxinA injections (compared to placebo)
- DrugPlacebos
Placebo prepared by Ipsen for use as control
- DeviceCustom Thoracolumbosacral Orthosis
Non-operative external bracing for scoliosis curves
Location
- Johns Hopkins UniversityBaltimore, Maryland