Dysport® + Bracing for Adolescent Idiopathic Scoliosis
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that interfere with neuromuscular function.
What data supports the effectiveness of the treatment for adolescent idiopathic scoliosis?
Research shows that using a thoracolumbosacral orthosis (TLSO), a type of back brace, can help control the curve progression in adolescent idiopathic scoliosis. In one study, patients who wore the TLSO showed a decrease in curve progression, with some achieving skeletal maturity with minimal curve changes.12345
How is the Dysport® + Bracing treatment for adolescent idiopathic scoliosis different from other treatments?
Dysport® + Bracing is unique because it combines a drug, Dysport® (a type of botulinum toxin used to relax muscles), with a custom thoracolumbosacral orthosis (a back brace) to treat adolescent idiopathic scoliosis. This approach is novel as it integrates muscle relaxation with physical support to potentially enhance the effectiveness of scoliosis management.12356
What is the purpose of 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.
Research Team
Varun Puvanesarajah, MD
Principal Investigator
Johns Hopkins Hospital Department of Orthopaedic Surgery
Paul Sponseller, MD, MBA
Principal Investigator
Johns Hopkins Hospital Department of Orthopaedic Surgery
Eligibility Criteria
This trial is for children aged 10-16 with adolescent idiopathic scoliosis, where the curve is below the T7 vertebra and measures 20°-40°. They should have no prior botulinum toxin treatment in the last 6 months, be able to follow a bracing protocol, and not have had spine surgery or need it currently. Kids with congenital or neuromuscular scoliosis, ongoing infections at potential injection sites, cow milk protein allergy, or on drugs affecting muscle function can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Dysport® or placebo injections in the paraspinal musculature and are treated with bracing
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AbobotulinumtoxinA
- Custom Thoracolumbosacral Orthosis
- Placebos
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor