Recruiting

Dysport with Bracing

Sponsor:

Johns Hopkins University

Code:

NCT03935295

Conditions

Adolescent Idiopathic Scoliosis

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

Interventions

AbobotulinumtoxinA

Placebos

Custom Thoracolumbosacral Orthosis

Study Details

Brief 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.

Conditions

Adolescent Idiopathic Scoliosis

Study ID

NCT03935295

Start date

Sep 3, 2020

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

AbobotulinumtoxinA

Paraspinal abobotulinumtoxinA injections (compared to placebo)

Placebos

Placebo prepared by Ipsen for use as control

Custom Thoracolumbosacral Orthosis

Non-operative external bracing for scoliosis curves

Primary outcome measure

  • Change in scoliotic curve as assessed by the Major Curve Cobb Angle [ Time Frame: Assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months ]

Central Contacts and Locations

Central contacts

Gabrielle Reichard, MA

4105023626greicha1@jhmi.edu

Varun Puvanesarajah, MD

9193605646vpuvane1@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Varun Puvanesarajah, MD

410-955-3136vpuvane1@jhmi.edu

Gabrielle Reichard, MA

4105023626greicha1@jh.edu

Principal Investigator:

Paul D Sponseller, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Keywords

  • AIS
  • adolescent idiopathic scoliosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-12-09.