0d641166ba5dba489ecfcdd528474468 toxins-16-00221.pdf c433ff63a5739bf6369fba33434a46a91ec8dfb8 toxins-16-00221.pdf 12a11f1813ee63596405d140d68fbb801ef9c11ef18506826c6ca79e962f3a5e toxins-16-00221.pdf Title: Effectiveness and Safety of OnabotulinumtoxinA in Adolescent Patients with Chronic Migraine Subject: Chronic migraine (CM) significantly affects underage individuals. The study objectives are (1) to analyze the effectiveness and safety of onabotulinumtoxinA (BTX-A) in adolescents with CM; (2) to review the literature on BTX-A use in the pediatric population. This prospective observational study included patients under 18 years old with CM treated with BTX-A (PREEMPT protocol) as compassionate use. Demographic, efficacy (monthly headache days—MHD; monthly migraine days—MMD; acute medication days/month—AMDM) and side effect data were collected. A 50% reduction in MHD was considered as a response. Effectiveness and safety were analyzed at 6 and 12 months. A systematic review of the use of BTX-A in children/adolescents was conducted in July 2023. In total, 20 patients were included (median age 15 years [14.75–17], 70% (14/20) females). The median basal frequencies were 28.8 [20–28] MHD, 18 [10–28] MMD and 10 [7.5–21.2] AMDM. Compared with baseline, at 6 months (n = 20), 11 patients (55%) were responders, with a median reduction in MHD of -20 days/month (p = 0.001). At 12 months (n = 14), eight patients (57.1%) were responders, with a median reduction in MHD of -17.5 days/month (p = 0.002). No adverse effects were reported. The literature search showed similar results. Our data supports the concept that BTX-A is effective, well tolerated, and safe in adolescents with CM resistant to oral preventatives. Keywords: migraine; onabotulinumtoxinA; adolescents; teenagers; children Author: Laura Gómez-Dabó, Edoardo Caronna, Rut Mas-de-les-Valls, Víctor J. Gallardo, Alicia Alpuente, Marta Torres-Ferrus and Patricia Pozo-Rosich Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Sat May 11 09:59:16 2024 CEST ModDate: Sat May 11 10:02:39 2024 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 12 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 935579 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- YWWVQQ+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 CLPCXI+URWPalladioL-Bold Type 1 Custom yes yes yes 16 0 ZZLSMO+URWPalladioL-Roma Type 1 Custom yes yes yes 22 0 UVLBTA+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 KOSUXD+CMSY10 Type 1 Builtin yes yes yes 32 0 DDMOHK+VnURWPalladioL Type 1 Custom yes yes yes 37 0 DVMWWR+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 54 0 PDIFNI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 77 0 PDIFNJ+PalatinoLinotype CID TrueType Identity-H yes yes yes 80 0 PDIFOK+PalatinoLinotype TrueType WinAnsi yes yes no 86 0 PDIFOM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 89 0 PDIGDL+PalatinoLinotype TrueType MacRoman yes yes no 92 0 PDIFNI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 102 0 PDIFNJ+PalatinoLinotype CID TrueType Identity-H yes yes yes 105 0 PDIFOK+PalatinoLinotype TrueType WinAnsi yes yes no 111 0 PDIFOM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 114 0 PDIIAB+Calibri CID TrueType Identity-H yes yes yes 117 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2025-11-25 04:12:15 CET RepresentationInformation: toxins-16-00221.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2025-11-24 18:31:27 CET Size: 935579 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 302 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Results Destination: section.2 Children: Item: Title: Case Series Destination: subsection.2.1 Children: Item: Title: Patient Characteristics Destination: subsubsection.2.1.1 Item: Title: Effectiveness Destination: subsubsection.2.1.2 Item: Title: Safety Destination: subsubsection.2.1.3 Item: Title: Narrative Review Destination: subsection.2.2 Item: Title: Discussion Destination: section.3 Item: Title: Conclusions Destination: section.4 Item: Title: Materials and Methods Destination: section.5 Children: Item: Title: Study Design, Population, and Outcomes Destination: subsection.5.1 Item: Title: Statistical Analysis Destination: subsection.5.2 Item: Title: Narrative Review: Search Strategy and Study Selection Destination: subsection.5.3 Item: Title: References Destination: appendix.A. Info: Title: Effectiveness and Safety of OnabotulinumtoxinA in Adolescent Patients with Chronic Migraine Author: Laura Gómez-Dabó, Edoardo Caronna, Rut Mas-de-les-Valls, Víctor J. Gallardo, Alicia Alpuente, Marta Torres-Ferrus and Patricia Pozo-Rosich Subject: Chronic migraine (CM) significantly affects underage individuals. The study objectives are (1) to analyze the effectiveness and safety of onabotulinumtoxinA (BTX-A) in adolescents with CM; (2) to review the literature on BTX-A use in the pediatric population. This prospective observational study included patients under 18 years old with CM treated with BTX-A (PREEMPT protocol) as compassionate use. Demographic, efficacy (monthly headache days MHD; monthly migraine days MMD; acute medication days/month AMDM) and side effect data were collected. A 50% reduction in MHD was considered as a response. Effectiveness and safety were analyzed at 6 and 12 months. A systematic review of the use of BTX-A in children/adolescents was conducted in July 2023. In total, 20 patients were included (median age 15 years [14.75 17], 70% (14/20) females). The median basal frequencies were 28.8 [20 28] MHD, 18 [10 28] MMD and 10 [7.5 21.2] AMDM. Compared with baseline, at 6 months (n = 20), 11 patients (55%) were responders, with a median reduction in MHD of -20 days/month (p = 0.001). At 12 months (n = 14), eight patients (57.1%) were responders, with a median reduction in MHD of -17.5 days/month (p = 0.002). No adverse effects were reported. The literature search showed similar results. Our data supports the concept that BTX-A is effective, well tolerated, and safe in adolescents with CM resistant to oral preventatives. 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