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NCT03935295 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Adolescent Idiopathic Scoliosis, sponsored by Johns Hopkins University.

Recruiting
Registry status
Phase 4
Development phase
90
Enrollment target
1
Study location

NCT03935295: Recruiting Phase 4 study of Adolescent Idiopathic Scoliosis, sponsored by Johns Hopkins University.

NCT03935295 is a Phase 4 study of Adolescent Idiopathic Scoliosis that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 90 participants, below the 265-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03935295, a Phase 4 study of Adolescent Idiopathic Scoliosis, is actively recruiting participants, sponsored by Johns Hopkins University.

RECRUITING
Registry status
Phase 4
Development phase
90 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Adolescent Idiopathic Scoliosis

Interventions

  • DRUG Placebos
  • DRUG AbobotulinumtoxinA
  • DEVICE Custom Thoracolumbosacral Orthosis

Study Locations (1)

Maryland

  • Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2020-09-03
Est. Completion 2026-12-31
Phase Phase 4
Johns Hopkins University

1,448 total trials

What NCT03935295 shows while recruiting

NCT03935295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 265-participant average among 7 other Adolescent Idiopathic Scoliosis trials with a reported enrollment target (66% lower).

The record links to 1 condition, with Adolescent Idiopathic Scoliosis appearing as the primary indexed condition, and to 3 interventions - of which Placebos is the first listed.

NCT03935295 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT03935295 about?

NCT03935295 is a clinical study titled "Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis". 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 a...

What is the current status of trial NCT03935295?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2020-09-03. Estimated completion is 2026-12-31.

What conditions does trial NCT03935295 study?

This clinical trial studies the following conditions: Adolescent Idiopathic Scoliosis.

What interventions are being tested in trial NCT03935295?

The interventions under investigation include: Placebos (DRUG), AbobotulinumtoxinA (DRUG), Custom Thoracolumbosacral Orthosis (DEVICE).

Who is sponsoring clinical trial NCT03935295?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03935295 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT03935295

Source: ClinicalTrials.gov NCT03935295, the US trial registry maintained by the National Library of Medicine. NCT03935295 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.