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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age10-16
SponsorJohns Hopkins University

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

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators