{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Berweck S"],"funding":["Merz (Germany)"],"pagination":["585"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9505819"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["14(9)"],"pubmed_abstract":["IncobotulinumtoxinA, a pure botulinumtoxinA formulation, is free of accessory proteins. This analysis provides pooled safety data from phase 3 trials of children/adolescents (2-17 years), investigating incobotulinumtoxinA for the treatment of spasticity associated with cerebral palsy (at doses ≤20 U/kg (max. 500 U) per injection cycle (IC) for ≤6 ICs; three trials) or sialorrhea associated with neurologic disorders (at total doses of 20-75 U per IC for ≤4 ICs; one trial) for ≤96 weeks. Safety endpoints included the incidences of different types of treatment-emergent adverse events (TEAEs) and immunogenicity. IncobotulinumtoxinA dose groups were combined. Of 1159 patients (mean age 7.3 years, 60.4% males) treated with incobotulinumtoxinA, 3.9% experienced treatment-related TEAEs, with the m"],"journal":["Toxins"],"pubmed_title":["Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis."],"pmcid":["PMC9505819"],"funding_grant_id":["N/A"],"pubmed_authors":["Banach M","Geister TL","Heinen F","Vacchelli M","Dabrowski E","Berweck S","Schroeder AS","Hanschmann A","Althaus M","Bonfert MV","Chambers HG","Gaebler-Spira D"],"additional_accession":[]},"is_claimable":false,"name":"Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis.","description":"IncobotulinumtoxinA, a pure botulinumtoxinA formulation, is free of accessory proteins. This analysis provides pooled safety data from phase 3 trials of children/adolescents (2-17 years), investigating incobotulinumtoxinA for the treatment of spasticity associated with cerebral palsy (at doses ≤20 U/kg (max. 500 U) per injection cycle (IC) for ≤6 ICs; three trials) or sialorrhea associated with neurologic disorders (at total doses of 20-75 U per IC for ≤4 ICs; one trial) for ≤96 weeks. Safety endpoints included the incidences of different types of treatment-emergent adverse events (TEAEs) and immunogenicity. IncobotulinumtoxinA dose groups were combined. Of 1159 patients (mean age 7.3 years, 60.4% males) treated with incobotulinumtoxinA, 3.9% experienced treatment-related TEAEs, with the m","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Aug","modification":"2025-04-21T20:12:43.079Z","creation":"2025-04-05T17:54:36.626Z"},"accession":"S-EPMC9505819","cross_references":{"pubmed":["36136523"],"doi":["10.3390/toxins14090585"]}}