Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis

Launched by JOHNS HOPKINS UNIVERSITY · Apr 30, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of a treatment called Dysport®, which is a type of botulinum toxin, combined with bracing for children and teens with adolescent idiopathic scoliosis (AIS). Adolescent idiopathic scoliosis is a condition where the spine curves abnormally in young people, and bracing is a common way to help manage this condition. In this trial, about two-thirds of the participants will receive Dysport® along with their brace, while the others will get a placebo (a treatment that looks like Dysport® but has no active medicine) along with bracing.

To be eligible for the trial, participants need to be between 10 and 16 years old and have a specific type of scoliosis that is not caused by other conditions. They should also have a spine curve that measures between 20° and 40°, and their condition must meet certain criteria related to their skeletal maturity. Those who join the study can expect to receive either the Dysport® treatment or a placebo, in addition to following a bracing protocol. The trial is currently looking for participants, and it is important to know that there are specific health conditions that would exclude someone from joining. Overall, this study aims to see if combining Dysport® with bracing can improve outcomes for young people with scoliosis.

Gender

ALL

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