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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03935295
Phase
PHASE4
Status
Recruiting
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Conditions

  • Adolescent Idiopathic Scoliosis

Eligibility Criteria

Sex
ALL
Age
10 Years - 16 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 3, 2020
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287
Varun Puvanesarajah, MD
[email protected]
410-955-3136
Gabrielle Reichard, MA
[email protected]
4105023626
Paul D Sponseller, MD (PRINCIPAL_INVESTIGATOR)

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Johns Hopkins University· Baltimore, MD

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