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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

Must not have

Current need for surgery at any level of the spine

Diagnosis as either resistant or sensitive to botulinum toxin treatment of any type or to any components of the BTX formulation

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

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery on my spine.

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I have a history of reacting to botulinum toxin treatments.

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I currently have an infection where I would get the injections.

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I am not taking any medication that affects muscle control.

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I have had surgery on my spine before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in Patient Reported Outcomes

Side effects data

From 2019 Phase 4 trial • 120 Patients • NCT03687736

Abdominoplasty

Intra-abdominal haemorrhage

Ureterolithiasis

100%

80%

60%

40%

20%

Study treatment Arm

AbobotulinumtoxinA

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 8Eligibility criteria met