Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Trial Parameters
Brief 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.
Eligibility Criteria
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 * Any other medical condition, laboratory or diagnostic procedure finding that might preclude administration of BTX * Ongoing infection at the injection sites * Diagnosis as either resistant or sensitive to botulinum toxin treatment of any type or to any components of the BTX formulation * Cow milk protein allergy