{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T12:28:38Z","timestamp":1782217718689,"version":"3.54.5"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T00:00:00Z","timestamp":1710806400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T00:00:00Z","timestamp":1710806400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Kafr El Shiekh University"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Acta Neurol Belg"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Migraine affects 11\u201315% of people worldwide, and the calcitonin gene-related peptide (CGRP) is released during the migraine attack, producing pulsating pain of migraine. Also, lacosamide reacts with collapsin-response mediator protein 2, preventing its phosphorylation and leading to the inhibition of CGRP release in the trigeminal system.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Objective<\/jats:title>\n                <jats:p>The primary outcome was the difference in the serum level of CGRP-LI after three months of treatment with either lacosamide and ibuprofen or ibuprofen alone in episodic migraine patients. The secondary outcomes were assessing safety and efficacy of lacosamide in episodic migraine patients.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We conducted an open-label randomized controlled trial on episodic migraine patients aged 10\u201355 years diagnosed according to (ICHD-3) in Kafr El-Sheikh University Hospital, Egypt. We assessed serum levels of CGRP-LI before and three months after treatment in our two groups, the lacosamide, and the control groups. We also assessed the side effects of treatment in each group, the percentage of patients who achieved\u2009\u2265\u200950% reduction in the migraine monthly days (MMD) frequency and the percentage of patients who achieved pain freedom within 2\u00a0h in\u2009\u2265\u20094 of 5 attacks in each group.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>200 episodic migraine patients completed the study. There was a statistically significantly higher reduction in the serum CGRP-LI level in the lacosamide group compared with the control group. In addition, lacosamide was well tolerated by patients. Also, the lacosamide group had statistically significant higher percentage of patients who achieved\u2009\u2265\u200950% reduction in the migraine monthly days (MMD) frequency and pain freedom within two hours in\u2009\u2265\u20094 of 5 attacks with <jats:italic>P<\/jats:italic>-values 0.002, 0.02 respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The daily use of lacosamide 50\u00a0mg Bid for three months in episodic migraine patients was associated with a significant reduction in serum CGRP-LI, better clinical outcomes regarding frequency and duration of migraine attacks, and was well tolerated by patients. These results were derived from an open-label pilot study that needed to be thoroughly investigated by a large-scale, randomized, double-blinded, placebo-controlled study.<\/jats:p>\n                <jats:p><jats:italic>Trial registration:<\/jats:italic>\u00a0We registered our trial on ClinicalTrials.gov, named after \"The Lacosamide's Effect on Calcitonin Gene-related Peptide in Migraine Patients,\" and with a clinical trial number (NCT05632133)\u2014August 8, 2023.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s13760-024-02499-9","type":"journal-article","created":{"date-parts":[[2024,3,19]],"date-time":"2024-03-19T14:02:08Z","timestamp":1710856928000},"page":"965-972","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["The effect of lacosamide on calcitonin gene-related peptide serum level in episodic migraine patients: a randomized, controlled trial"],"prefix":"10.1007","volume":"124","clinical-trial-number":[{"clinical-trial-number":"nct05632133","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Shimaa","family":"Elgamal","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherihan Rezk","family":"Ahmed","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed M.","family":"Nahas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shimaa R.","family":"Hendawy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osama","family":"Elshafei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0337-349X","authenticated-orcid":false,"given":"Mohamed G.","family":"Zeinhom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,3,19]]},"reference":[{"key":"2499_CR1","doi-asserted-by":"publisher","DOI":"10.1007\/s13760-022-02015-x","author":"SR Ahmed","year":"2022","unstructured":"Ahmed SR, Mohamed AAM, Salem HH, Helmy S, Moustafa RR, Borham SMF (2022) Association of white matter hyperintensities with migraine phenotypes and response to treatment. Acta Neurol Belg. https:\/\/doi.org\/10.1007\/s13760-022-02015-x","journal-title":"Acta Neurol Belg"},{"issue":"14","key":"2499_CR2","doi-asserted-by":"publisher","first-page":"1191","DOI":"10.1212\/WNL.0b013e3182a6cb72","volume":"81","author":"E Cernuda-Moroll\u00f3n","year":"2013","unstructured":"Cernuda-Moroll\u00f3n E, Larrosa D, Ram\u00f3n C, Vega J, Mart\u00ednez-Camblor P, Pascual J (2013) Interictal increase of CGRP levels in peripheral blood as a biomarker for chronic migraine. Neurology 81(14):1191\u20131196","journal-title":"Neurology"},{"issue":"1","key":"2499_CR3","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s10194-022-01483-z","volume":"23","author":"LS de Vries","year":"2022","unstructured":"de Vries LS, Garrelds IM, Danser AHJ, Terwindt GM, Maassen Van Den Brink A (2022) Serum CGRP in migraine patients using erenumab as preventive treatment. 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All methods of our trial were performed following the guidelines and regulations of the Faculty of Medicine Ain Shams University (FMASU), which is organized and operated according to the guidelines of the International Council on Harmonization ICH), Anesthesiology and the Islamic Organization for Medical Service (IOMS), the United States Office for Human Research Protections, and the United States Code of Federal Regulations, and operates under Federal Wide Assurance no (FWA00001785). Our trial is registered in clinicaltrials.gov under NCT05632133.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Before randomization, formal written informed consent was obtained from the included patients or their first-degree relatives.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}