Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Recruiting
Phase 4
Interventional Study
Adolescent Idiopathic Scoliosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 10 – 16
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Johns Hopkins University · Other
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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.
Trial Locations
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Eligibility Criteria
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…
Contacts