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

ConditionAdolescent Idiopathic Scoliosis

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age10-16

SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically determined idiopathic nature of scoliosis

Age 10-16 years

Risser stage 0,1,or 2

major curve of 20°-40°

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

AbobotulinumtoxinA
Drug
Paraspinal abobotulinumtoxinA injections (compared to placebo)
Placebos
Drug
Placebo prepared by Ipsen for use as control
Custom Thoracolumbosacral Orthosis
Device
Non-operative external bracing for scoliosis curves

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Botulinum ToxinExperimental treatment 2 interventions

Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

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

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.

Time frame

Assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months

Secondary outcomes

Change in Patient Reported Outcomes

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.

Time frame

Assessed at baseline (time 0), 6 weeks, 4 months, 4 months + 6 weeks, 8 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov

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