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

StatusRecruiting
PhasePhase 4
Started2020-09-03
View on ClinicalTrials.gov ↗

Amendment history

2025-12-05
Study Status v17
Primary completion date2025-12-31→2026-12-31
Completion date2026-03-31→2026-12-31
2024-12-17
Study Status v16
Primary completion date2024-12-31→2025-12-31
2024-04-09
Study Status v15
Primary completion date2024-06→2024-12-31
Completion date2025-03→2026-03-31
2023-04-13
Study Status, Contacts/Locations v14
Primary completion date2023-04→2024-06
Completion date2023-04→2025-03
2022-09-12
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
Show 12 earlier versions
2021-09-20
Study Status, Contacts/Locations v12
Re-verified, no change to tracked fields
2020-09-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v11
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-09→confirmed 2020-09-03
Study sites0→1
2020-08-31
Study Status v10
Start date2020-08→2020-09
2020-07-15
Study Status v9
Primary completion date2023-03→2023-04
Completion date2023-03→2023-04
Start date2020-07→2020-08
2020-06-17
Study Status v8
Primary completion date2023-02→2023-03
Completion date2023-02→2023-03
Start date2020-06→2020-07
2020-04-10
Study Status v7
Primary completion date2022-12→2023-02
Completion date2022-12→2023-02
Start date2020-04→2020-06
2020-02-03
Study Identification, Study Status, Study Description, Arms and Interventions v6
Study description+63 characters
[...] during bracing of AIS patients. One therapy in particular, botulinum toxinabobotulinumtoxinA (BTX) injection, has been poorly studied. Injection of BTX [...] y. 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 scol [...] ure AIS patients who are concurrently treated with bracing. BTX injectionsDysport® will be evaluated primarily as an adjunct treatment to bracing. Hypotheses BTXDysport® injections into the concave-side paraspinal muscles will de [...] wer rate of curve progression in patients treat [...]
Study title-5 characters
TheDysport Use® ofas Botulinuman ToxinAdjunctive A Injections As An AdjunctTreatment to Bracing toin Treatthe Management of Adolescent Idiopathic Scoliosis
2020-01-15
Study Identification, Study Status v5
Start date2019-12→2020-04
2019-11-19
Study Status v4
Primary completion date2022-11→2022-12
Completion date2022-11→2022-12
Start date2019-11→2019-12
2019-08-12
Study Status v3
Primary completion date2022-07→2022-11
Completion date2022-07→2022-11
Start date2019-07→2019-11
2019-05-31
Study Status v2
Primary completion date2022-05-15→2022-07
Completion date2027-05-15→2022-07
Start date2019-05-15→2019-07
2019-05-01
Study Status, Eligibility v1
Eligibility criteria-56 characters
Inclusion criteria: 1) Clinically determined idiopathic nature of scoliosis; 2) age Age 10-16 years; 3) Risser stage 0,1,or 2; 4) major curve of 20°-40°; 5) curve apex caudal to T7 vertebra; and 6) ability to adhere to bracing protocol 7) Botulinum toxin naïve or previously treated greater than 6 months prior to study entry Exclusion criteria: 1) Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other "reason" for scoliosis; or- 2) previousPrevious surgery at any segment of the spine 3) current Current need for surgery at any level of the spine 4) treatment Treatment with any [...] [...]
2019-04-30
Original filing
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 Details
NCT Number NCT03935295
Lead Sponsor Johns Hopkins University
Conditions Adolescent Idiopathic Scoliosis
Enrollment 90 participants
Start Date 2020-09-03
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-09