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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

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