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Considering the clinical similarities between migraine and persistent post-traumatic headache (PPTH), we aimed to examine whether MaxiPost (a BK<jats:sub>Ca<\/jats:sub> channel opener) could induce migraine-like headache in persons with PPTH.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This is a randomized double-blind, placebo-controlled, two-way crossover study from September 2023 to December 2023. Eligible participants were adults with PPTH after mild traumatic brain injury who reported having no personal history of migraine. The randomized participants received a single dose of either MaxiPost (0.05 mg\/min) or placebo (isotonic saline) that was infused intravenously over 20 minutes. The two experiment sessions were scheduled at least one week apart to avoid potential carryover effects. The primary endpoint was the induction of migraine-like headache after MaxiPost as compared to placebo within 12 hours of drug administration. The secondary endpoint was the area under the curve (AUC) values for headache intensity scores between MaxiPost and placebo over the same 12-hour observation period.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Twenty-one adult participants (comprising 14 females and 7 males) with PPTH were enrolled and completed both experiment sessions. The proportion of participants who developed migraine-like headache was 11 (52%) of 21 participants after MaxiPost infusion, in contrast to four (19%) participants following placebo (<jats:italic>P<\/jats:italic> = .02). Furthermore, the median headache intensity scores, represented by AUC values, were higher following MaxiPost than after placebo (<jats:italic>P<\/jats:italic> &lt; .001).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Our results indicate that BK<jats:sub>Ca<\/jats:sub> channel opening can elicit migraine-like headache in persons with PPTH. Thus, pharmacologic blockade of BK<jats:sub>Ca<\/jats:sub> channels might present a novel avenue for drug discovery. Additional investigations are nonetheless needed to confirm these insights and explore the therapeutic prospects of BK<jats:sub>Ca<\/jats:sub> channel blockers in managing PPTH.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>ClinicalTrials.gov Identifier<\/jats:title>\n                <jats:p>NCT05378074.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s10194-024-01808-0","type":"journal-article","created":{"date-parts":[[2024,6,18]],"date-time":"2024-06-18T12:02:00Z","timestamp":1718712120000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Hypersensitivity to BKCa channel opening in persistent post-traumatic headache"],"prefix":"10.1186","volume":"25","author":[{"given":"Haidar M.","family":"Al-Khazali","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rune H.","family":"Christensen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David W.","family":"Dodick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Basit Ali","family":"Chaudhry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna G.","family":"Melchior","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rami","family":"Burstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e5kan","family":"Ashina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,6,18]]},"reference":[{"key":"1808_CR1","doi-asserted-by":"publisher","first-page":"607","DOI":"10.1038\/s41582-019-0243-8","volume":"15","author":"H Ashina","year":"2019","unstructured":"Ashina H, Porreca F, Anderson T et al (2019) Post-traumatic headache: epidemiology and pathophysiological insights. 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J Headache Pain 21:55. https:\/\/doi.org\/10.1186\/s10194-020-01122-5","journal-title":"J Headache Pain"}],"container-title":["The Journal of Headache and Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s10194-024-01808-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s10194-024-01808-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s10194-024-01808-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,18]],"date-time":"2024-06-18T12:02:06Z","timestamp":1718712126000},"score":1,"resource":{"primary":{"URL":"https:\/\/thejournalofheadacheandpain.biomedcentral.com\/articles\/10.1186\/s10194-024-01808-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,18]]},"references-count":46,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["1808"],"URL":"https:\/\/doi.org\/10.1186\/s10194-024-01808-0","relation":{},"ISSN":["1129-2377"],"issn-type":[{"value":"1129-2377","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,18]]},"assertion":[{"value":"25 May 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 June 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 June 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study protocol was approved by the ethics committee of Capital Region, Denmark, and written informed consent was obtained from all participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"H.M.A. reports personal fees from Pfizer, outside of the submitted work. D.W.D reports the following competing interest. Consulting: Amgen, Atria, CapiThera Ltd., Cerecin, Ceruvia Lifesciences LLC, CoolTech, Ctrl M, Allergan, AbbVie, Biohaven, GlaxoSmithKline, Lundbeck, Eli Lilly, Novartis, Impel, Satsuma, Theranica, WL Gore, Genentech, Nocira, Perfood, Praxis, AYYA Biosciences, Revance, Pfizer. Honoraria: American Academy of Neurology, Headache Cooperative of the Pacific, Canadian Headache Society, MF Med Ed Research, Biopharm Communications, CEA Group Holding Company (Clinical Education Alliance LLC), Teva (speaking), Amgen (speaking), Eli Lilly (speaking), Lundbeck (speaking), Pfizer (speaking), Vector Psychometric Group, Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, Medica Communications LLC, MJH Lifesciences, Miller Medical Communications, WebMD Health\/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press. Non-profit board membership: American Brain Foundation, American Migraine Foundation, ONE Neurology, Precon Health Foundation, International Headache Society Global Patient Advocacy Coalition, Atria Health Collaborative, Arizona Brain Injury Alliance, Domestic Violence HOPE Foundation\/Panfila. Research support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, Henry Jackson Foundation, Patient Centered Outcomes Research Institute (PCORI). Stock options\/shareholder\/patents\/board of directors: Aural analytics (options), Axon Therapeutics (shares\/board), ExSano (options), Palion (options), Man and Science, Healint (options), Theranica (options), Second Opinion\/Mobile Health (options), Epien (options), Nocira (options), Matterhorn (shares), Ontologics (shares), King-Devick Technologies (options\/board), EigenLyfe (shares), AYYA Biosciences (options), Cephalgia Group (shares\/board), Atria Health (options\/employee). Patent 17189376.1-1466:vTitle: Onabotulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis (Non-royalty bearing). Patent application submitted: Synaquell\u00ae (Precon Health). R.B. reports research support received from Allergan, Dr. Reddy's Laboratories, Eli Lilly, and Teva, outside of the submitted work. In addition, R.B. has received honoraria, acted as a consultant or advisory board member for Alder, Allergan, Amgen, Autonomic Technologies, Avanir, Biohaven, CGRP Diagnostics, Dr. Reddy's Laboratories, ElectroCore, Eli Lilly, GlaxoSmithKline, Merck, Pernix, Teva, and Trigemina. R.B. also reports receiving CME fees from Healthlogix, Medlogix, and WebMD\/Medscape, and holds patents for several products, including (9061025, 11732265.1, 10806890, US2021-0015908, WO21007165, US2021-0128724, WO21005497). R.B. is a reviewer for the National Institute of Neurological Disorders and Stroke (NINDS) and holds stock options in Allay Lamp and Percept, outside of the submitted work. H.A. reports personal fees from Lundbeck and Teva, outside of the submitted work. The remaining authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"102"}}