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Dysport® + Bracing for Adolescent Idiopathic Scoliosis

Phase 4

Recruiting

Led By Paul Sponseller, MD, MBA

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

major curve of 20°-40°

Clinically determined idiopathic nature of scoliosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months

Awards & highlights

Study Summary

This trial will see if botulinum toxin A, when given with bracing, can help improve scoliosis in children better than bracing alone.

Who is the study for?

This trial is for children aged 10-16 with adolescent idiopathic scoliosis, where the curve is below the T7 vertebra and measures 20°-40°. They should have no prior botulinum toxin treatment in the last 6 months, be able to follow a bracing protocol, and not have had spine surgery or need it currently. Kids with congenital or neuromuscular scoliosis, ongoing infections at potential injection sites, cow milk protein allergy, or on drugs affecting muscle function can't join.Check my eligibility

What is being tested?

The study tests if Dysport® (botulinum toxin A) combined with wearing a custom back brace helps manage scoliosis better than just wearing the brace alone. Two-thirds of participants will receive Dysport® injections along with bracing; the rest will get placebo injections plus bracing.See study design

What are the potential side effects?

Dysport® may cause muscle weakness near where it's injected, pain at injection site, flu-like symptoms, upper respiratory tract infections and allergic reactions like rash or itching. Side effects are specific to each individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spine's major curve is between 20° and 40°.

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My scoliosis has no known cause.

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I am between 10 and 16 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in scoliotic curve as assessed by the Major Curve Cobb Angle

Secondary outcome measures

Change in Patient Reported Outcomes

Side effects data

From 2019 Phase 4 trial • 120 Patients • NCT03687736

Intra-abdominal haemorrhage

Abdominoplasty

Ureterolithiasis

100%

80%

60%

40%

20%

Study treatment Arm

AbobotulinumtoxinA

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Botulinum ToxinExperimental Treatment2 Interventions

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.

Group II: PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Botulinum toxin type A

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,407 Total Patients Enrolled

Paul Sponseller, MD, MBAPrincipal InvestigatorJohns Hopkins Hospital Department of Orthopaedic Surgery

Varun Puvanesarajah, MDPrincipal InvestigatorJohns Hopkins Hospital Department of Orthopaedic Surgery

Media Library

Custom Thoracolumbosacral Orthosis Clinical Trial Eligibility Overview. Trial Name: NCT03935295 — Phase 4

Adolescent Idiopathic Scoliosis Research Study Groups: Botulinum Toxin, Placebo

Adolescent Idiopathic Scoliosis Clinical Trial 2023: Custom Thoracolumbosacral Orthosis Highlights & Side Effects. Trial Name: NCT03935295 — Phase 4

Custom Thoracolumbosacral Orthosis 2023 Treatment Timeline for Medical Study. Trial Name: NCT03935295 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you elucidate the potential hazards associated with AbobotulinumtoxinA?

"AbobotulinumtoxinA is safe and has been approved by regulatory authorities, so it earned a score of 3."

Answered by AI

Does the experimental protocol accept geriatric participants?

"Applicants aged between 10 to 16 can apply for this trial. Moreover, 73 trials are available to minors and 70 trials are accessible for senior citizens over the age of 65."

Answered by AI

What ailments is AbobotulinumtoxinA typically prescribed for?

"AbobotulinumtoxinA is often utilized to treat urinary incontinence and has been known to improve the symptoms of spinal cord, botox, and overactive bladder syndrome (OABs)."

Answered by AI

Is there still room for participants in this clinical study?

"According to the information accessible on clinicaltrials.gov, recruitment for this medical experiment is currently ongoing. It was initially shared on September 3rd 2020 and has since been updated as of September 12th 2022."

Answered by AI

Has AbobotulinumtoxinA been evaluated in any past research endeavors?

"Presently, 61 research studies exploring AbobotulinumtoxinA are underway with 20 of them in their final phase. Though most tests take place at Farmington Hills, Michigan, there exist 759 other clinical sites conducting this type of investigation."

Answered by AI

What is the enrollment figure for this clinical examination?

"Affirmative. According to the clinicaltrials.gov portal, this medical trial has been open for recruitment since September 3rd 2020 and was recently updated on September 12th 2022. The study requires 90 patients from one particular site."

Answered by AI

Am I eligible to participate in this research project?

"This medical experiment is searching for 90 individuals between the ages of 10 and 16 with androgen-insensitivity syndrome. Additional requirements are that the participants have not received botulinum toxin in 6 months prior to study enrollment, possess scoliosis stemming from an idiopathic source, a curvature magnitude ranging between 20° - 40°, curve apex located below T7 vertebrae, and Risser stage 0, 1 or 2."

Answered by AI

Recent research and studies

ScoliosisJournal

Adolescent Idiopathic Scoliosis: Natural History and Long Term Treatment Effects

Asher, Marc A, and Douglas C Burton. 2006. “Adolescent Idiopathic Scoliosis: Natural History and Long Term Treatment Effects”. Scoliosis. Springer Science and Business Media LLC. doi:10.1186/1748-7161-1-2.

SpineJournal

Idiopathic Scoliosis

WEINSTEIN, STUART L.. 1986. “Idiopathic Scoliosis”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00007632-198610000-00006.

New England Journal of MedicineJournal

Effects of Bracing in Adolescents with Idiopathic Scoliosis

Weinstein, Stuart L., Lori A. Dolan, James G. Wright, and Matthew B. Dobbs. 2013. “Effects of Bracing in Adolescents with Idiopathic Scoliosis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1307337.

SpineJournal