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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

Sponsor: Johns Hopkins University · Participants: 90 · Started: Sep 3, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT03935295

Locations in the U.S.

MarylandJohns Hopkins University, Baltimore

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.