Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Who is this study for? Children with adolescent idiopathic scoliosis
What treatments are being studied? AbobotulinumtoxinA
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 16
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Contact Information
Primary
Gabrielle Reichard, MA
greicha1@jhmi.edu
4105023626
Backup
Varun Puvanesarajah, MD
vpuvane1@jhmi.edu
9193605646
Time Frame
Start Date: 2020-09-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Botulinum Toxin
The investigators plan to administer approximately 1000 U Dysport ® in the concave-sided paraspinal musculature of the major curve, based on an estimated total dose of 1000 U, the maximum allowable dose. The total dose per treatment session will not exceed 15 units/kilogram or 1000 units, whichever is lower. If two curves are equivalent within 3˚, both will be treated, however, the dosing (described above) will be divided equally across both curves.~There will be two cycles of injections. Patients will be treated at time 0 (baseline) and 4 months.
Placebo_comparator: Placebo
Control patients will receive an injection of placebo specifically prepared as a control for this study. The same volumes as indicated in the experimental arm description will be injected.~These will be administered during two cycles of injections. Patients will be treated at time 0 (baseline) and 4 months.
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University