About this trial
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.
Eligibility criteria
Qualifiers
Clinically determined idiopathic nature of scoliosis
Age 10-16 years
Risser stage 0,1,or 2
major curve of 20°-40°
Disqualifiers
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
Any other medical condition, laboratory or diagnostic procedure finding that might preclude administration of BTX
Trial design
Treatments tested in this trial
- AbobotulinumtoxinA
- Placebos
- Custom Thoracolumbosacral Orthosis