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

NCT03935295 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

DRUG

AbobotulinumtoxinA

Paraspinal abobotulinumtoxinA injections (compared to placebo)

DRUG

Placebos

Placebo prepared by Ipsen for use as control

DEVICE

Custom Thoracolumbosacral Orthosis

Non-operative external bracing for scoliosis curves

Sponsors & Collaborators

Principal Investigators

  • Paul Sponseller, MD, MBA · Johns Hopkins Hospital Department of Orthopaedic Surgery

  • Varun Puvanesarajah, MD · Johns Hopkins Hospital Department of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935295 on ClinicalTrials.gov