Home › NCT03935295
Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
RecruitingPhase 4
Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Who can join
Ages 10 to 16 · All sexes
Full 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
About the study
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.
What is being tested
- AbobotulinumtoxinA (drug)
- Placebos (drug)
- Custom Thoracolumbosacral Orthosis (device)
Sponsor: Johns Hopkins University · Participants: 90 · Started: Sep 3, 2020
Contact the study team
- Gabrielle Reichard, MA · Phone: 4105023626
- Varun Puvanesarajah, MD · Phone: 9193605646
Official record on ClinicalTrials.gov — NCT03935295
Locations in the U.S.
| Maryland | Johns Hopkins University, Baltimore |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.