Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Johns Hopkins University
90 participants
Sep 3, 2020
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 Criteria7
- 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
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Interventions
Paraspinal abobotulinumtoxinA injections (compared to placebo)
Placebo prepared by Ipsen for use as control
Non-operative external bracing for scoliosis curves
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03935295