We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03935295
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : September 13, 2022
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Drug: AbobotulinumtoxinA Drug: Placebos Device: Custom Thoracolumbosacral Orthosis Phase 4

Detailed Description:

Adolescent idiopathic scoliosis (AIS) is lateral curvature of the spine with an unknown cause in children 10-16 years old. Without treatment, skeletally immature children with idiopathic curves of 20°-40° risk curve progression. Treatment of these patients is focused on either observation or bracing. Although bracing has been shown to be more effective than observation, success is contingent on patient adherence and has the potential for further optimization with adjunct therapies.

Little research is available concerning adjunct therapies that may be used during bracing of AIS patients. One therapy in particular, abobotulinumtoxinA (BTX) injection, has been poorly studied. Injection of BTX into the paraspinal musculature of the concave aspect of the major curve may result in a more malleable curve and thus optimize brace treatment. If BTX injections are found to improve outcomes in this way, a new standard of nonoperative care could be established for AIS patients, potentially reducing the number of patients who undergo surgery.

The aim of this study is to assess whether BTX injections (administered as Dysport® (Ipsen Pharmaceuticals)) in the paraspinal musculature at the site of the major scoliotic curve decrease curve progression in skeletally immature AIS patients who are concurrently treated with bracing. Dysport® will be evaluated primarily as an adjunct treatment to bracing.


  1. Dysport® injections into the concave-side paraspinal muscles will decrease the rate of curve progression, with a lower rate of curve progression in patients treated with both Dysport® injections and bracing compared with those treated with only bracing.
  2. Quantitative physical and mental health scores will improve to a greater extent in patients treated with Dysport® and bracing compared with patients treated with only bracing.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Scoliosis

Arm Intervention/treatment
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.

Drug: AbobotulinumtoxinA
Paraspinal abobotulinumtoxinA injections (compared to placebo)
Other Name: Dysport, Ipsen

Device: Custom Thoracolumbosacral Orthosis
Non-operative external bracing for scoliosis curves

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.

Drug: Placebos
Placebo prepared by Ipsen for use as control

Device: Custom Thoracolumbosacral Orthosis
Non-operative external bracing for scoliosis curves

Primary Outcome Measures :
  1. 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 ]
    Change in scoliotic curve will be assessed using by the Major Curve Cobb Angle with measurement of standing scoliosis radiographs. Cobb angle refers to a radiographic measurement of side to side spinal curvature, measured in angle degrees.

Secondary Outcome Measures :
  1. Change in Patient Reported Outcomes [ Time Frame: Assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months ]
    This will be assessed by Scoliosis Research Society (SRS) 22 Survey; The SRS-22 questionnaire is a validated measure used to assesses quality of life in patients with idiopathic scoliosis. It consists of five domains that assess: function, pain, mental health, self-image, and satisfaction with treatment. Higher scores indicate increased satisfaction. Each of the 22 questions are scored on a scale of 1 to 5.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935295

Layout table for location contacts
Contact: Frederick Mun, BS 4124827928 fmun1@jh.edu
Contact: Varun Puvanesarajah, MD 9193605646 vpuvane1@jhmi.edu

Layout table for location information
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Varun Puvanesarajah, MD    410-955-3136    vpuvane1@jhmi.edu   
Contact: Gabrielle Reichard, MA    4105023626    greicha1@jh.edu   
Principal Investigator: Paul D Sponseller, MD         
Sponsors and Collaborators
Johns Hopkins University
Layout table for investigator information
Principal Investigator: Paul Sponseller, MD, MBA Johns Hopkins Hospital Department of Orthopaedic Surgery
Principal Investigator: Varun Puvanesarajah, MD Johns Hopkins Hospital Department of Orthopaedic Surgery
Additional Information:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03935295    
Other Study ID Numbers: IRB00110399
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Johns Hopkins University:
adolescent idiopathic scoliosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents