{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T05:32:10Z","timestamp":1790314330298,"version":"4.1.0"},"reference-count":14,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2017,10,12]],"date-time":"2017-10-12T00:00:00Z","timestamp":1507766400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2018,2]]},"abstract":"\n Objective<\/jats:title>\n To determine the efficacy, tolerability, and safety of ascending doses of Adhesive Dermally-Applied Microarray (ADAM) zolmitriptan versus placebo for acute migraine treatment.<\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n ADAM is a novel patient-administered system for intracutaneous drug administration. In a phase 1 pharmacokinetic study, zolmitriptan administered using ADAM had much faster absorption than oral administration with higher exposure in the first two hours.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2b\/3 study evaluating ADAM zolmitriptan 1\u2009mg, 1.9\u2009mg, and 3.8\u2009mg versus placebo. Co-primary endpoints were pain freedom and freedom from most bothersome other migraine-associated symptom 2 hours post-dose.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Of patients treated with ADAM zolmitriptan 3.8\u2009mg or placebo, 41.5% and 14.2%, respectively were pain-free 2 hours post-dose ( p\u2009=\u20090.0001) and 68.3% and 42.9% were free from their most bothersome other symptom ( p\u2009=\u20090.0009). Due to the fixed sequential testing methodology, formal statistical significance was not established for secondary endpoints. However, the proportion of patients who were photophobia-free, phonophobia-free, and nausea-free at 2 hours post-dose was higher in the ADAM zolmitriptan 3.8\u2009mg group compared with placebo, as were the percentages of patients who were pain-free, and who experienced pain relief up to 48 hours post-dose. Systemic adverse events were consistent with previous triptan trials, and included dizziness, paresthesia, muscle tightness, and nausea, all of which occurred in\u2009<\u20095% of patients in any group. Application site reactions were generally mild and resolved within 48 hours, although erythema and bruising persisted for longer periods in some patients.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n ADAM zolmitriptan 3.8\u2009mg provides effective relief of migraine headache and associated most bothersome symptoms compared with placebo, and is well-tolerated.<\/jats:p>\n <\/jats:sec>\n \n ClinicalTrials.gov<\/jats:title>\n NCT02745392<\/jats:p>\n <\/jats:sec>","DOI":"10.1177\/0333102417737765","type":"journal-article","created":{"date-parts":[[2017,10,12]],"date-time":"2017-10-12T09:29:01Z","timestamp":1507800541000},"page":"215-224","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":65,"title":["Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine"],"prefix":"10.1177","volume":"38","author":[{"given":"Egilius LH","family":"Spierings","sequence":"first","affiliation":[{"name":"MedVadis Research Corporation, Watertown, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan Lewis","family":"Brandes","sequence":"additional","affiliation":[{"name":"Nashville Neuroscience Group, Nashville, TN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David B","family":"Kudrow","sequence":"additional","affiliation":[{"name":"California Medical Clinic for Headache, Santa Monica, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Weintraub","sequence":"additional","affiliation":[{"name":"Michigan HeadPain and Neurological Institute, Ann Arbor, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter C","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Zosano Pharma, Fremont, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald J","family":"Kellerman","sequence":"additional","affiliation":[{"name":"Zosano Pharma, Fremont, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stewart J","family":"Tepper","sequence":"additional","affiliation":[{"name":"Neurology Department, Geisel School of Medicine at Dartmouth and Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA"},{"name":"On behalf of the ZOLMI investigators"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,10,12]]},"reference":[{"key":"bibr1-0333102417737765","first-page":"271","volume":"83","author":"Gilmore B","year":"2011","journal-title":"Am Fam Phys"},{"key":"bibr2-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1111\/head.12499"},{"key":"bibr3-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2009.02748.x"},{"key":"bibr4-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1001\/jama.284.20.2599"},{"key":"bibr5-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04167.x"},{"key":"bibr6-0333102417737765","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-197803040-00004"},{"key":"bibr7-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1007\/s11916-005-0064-x"},{"key":"bibr8-0333102417737765","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200241110-00002"},{"key":"bibr9-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.61.8_suppl_4.S27"},{"key":"bibr10-0333102417737765","doi-asserted-by":"crossref","unstructured":"Kellerman DJ, Ameri M and Tepper SJ. Rapid systemic delivery of zolmitriptan using an adhesive dermally applied microarray.\n Pain Manage\n . Epub ahead of print 26 July 2017. DOI: 10.2217\/pmt-2017-0036.","DOI":"10.2217\/pmt-2017-0036"},{"key":"bibr11-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1177\/0333102411417901"},{"key":"bibr12-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.2002.00404.x"},{"key":"bibr13-0333102417737765","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.2000.00004.x"},{"key":"bibr14-0333102417737765","unstructured":"Food and Drug Administration (FDA) Guidance for Industry. Migraine: Developing drugs for acute treatment. https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm419465.pdf (accessed 14 June 2017)."}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0333102417737765","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0333102417737765","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0333102417737765","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:47:42Z","timestamp":1777387662000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/0333102417737765"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,10,12]]},"references-count":14,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2018,2]]}},"alternative-id":["10.1177\/0333102417737765"],"URL":"https:\/\/doi.org\/10.1177\/0333102417737765","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,10,12]]}}}