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Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

RecruitingPhase 4Ages 10 Years - 16 YearsAllJohns Hopkins University
NCT03935295 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • AbobotulinumtoxinA
  • Placebos
  • Custom Thoracolumbosacral Orthosis
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Where

1 site
Johns Hopkins University
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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