Actively Recruiting
Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Led by Johns Hopkins University · Updated on 2025-12-09
90
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically determined idiopathic scoliosis
- Age between 10 and 16 years
- Risser stage 0, 1, or 2
- Major spinal curve between 20° and 40°
- Curve apex below the T7 vertebra
- Ability to follow the bracing protocol
- No botulinum toxin treatment in the last 6 months or never treated before
You will not qualify if you...
- Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other specific cause of scoliosis
- Previous spine surgery at any level
- Current need for spinal surgery
- Use of drugs that affect neuromuscular function
- Any medical condition or test result preventing botulinum toxin use
- Infection at injection sites
- Known resistance or sensitivity to botulinum toxin or its components
- Allergy to cow milk protein
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
G
Gabrielle Reichard, MA
CONTACT
V
Varun Puvanesarajah, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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