{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T17:43:32Z","timestamp":1794246212826,"version":"4.9.0"},"reference-count":29,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T00:00:00Z","timestamp":1751241600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T00:00:00Z","timestamp":1751241600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the safety, tolerability, and treatment effects of rimegepant 75\u2009mg every other calendar day (EOD) for the preventive treatment of migraine in a 52\u2010week, open\u2010label extension (OLE) study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Rimegepant is an oral small molecule calcitonin gene\u2013related peptide receptor antagonist approved for the acute treatment of migraine and the preventive treatment of episodic migraine in adults. The efficacy and safety of rimegepant for preventive treatment of migraine was demonstrated in a 12\u2010week, phase 2\/3, randomized, double\u2010blind (DB), placebo\u2010controlled trial in which rimegepant treatment produced significant improvement in the number of monthly migraine days (MMDs) with a safety profile similar to placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the DB trial period, an initial 4\u2010week observation period was followed by a randomized, DB, 12\u2010week treatment period. This was an optional 52\u2010week OLE following the initial DB study for adults who completed the DB period. Participants were instructed to take one tablet of rimegepant 75\u2009mg EOD for 52\u2009weeks. If participants required an acute treatment of migraine on a non\u2010scheduled dosing day, they could take one tablet of rimegepant 75\u2009mg on that day (as\u2010needed dosing). Secondary endpoints evaluated the safety and tolerability of rimegepant, including the frequencies of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt;\u20093\u00d7 upper limit of normal (ULN) concurrent with total bilirubin (TBIL) &gt;\u20092\u00d7 ULN, hepatic\u2010related adverse events (AEs), and hepatic\u2010related AEs leading to rimegepant discontinuation. Exploratory endpoints included the mean reduction in the number of MMDs. The study (DB and OLE) was conducted from November 2018 to February 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 603 participants who entered the OLE period, 428 (71.0%) completed the study. Overall, 312 (51.7%) participants reported at least one on\u2010study AE and most events were mild in severity. Severe AEs were reported in 14 (2.3%) participants. Serious AEs were reported in 13 participants (2.2%); none were liver related. AEs considered related to rimegepant were reported in 91 (15.1%) participants; the most frequently reported were constipation (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096, 1.0%), upper respiratory tract infection (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095, 0.8%), nausea, migraine, ALT increased, AST increased, and weight increased (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20094, 0.7% each). Hepatic\u2010related AEs occurred with low frequency (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200911, 1.8%). AEs leading to rimegepant discontinuation were also uncommon (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200917, 2.8%); two (0.3%) discontinued due to liver enzyme\u2013related AEs. No participant had ALT or AST &gt;\u20093\u00d7 ULN concurrent with TBIL &gt;\u20092\u00d7 ULN. Over the OLE period, there was a mean (standard deviation) decrease of 6.2 (3.81) days in the number of MMDs. Mean MMDs and participants achieving categorical response rates improved over the OLE period, without any evidence of a diminution of effect.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The OLE data showed favorable tolerability and sustained and increasing treatment benefits with rimegepant 75\u2009mg (EOD and as\u2010needed dosing) over 52\u2009weeks for the preventive treatment of migraine. NCT03732638.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.15002","type":"journal-article","created":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T05:29:06Z","timestamp":1751261346000},"page":"407-416","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["A 52\u2010week open\u2010label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine"],"prefix":"10.1111","volume":"66","author":[{"given":"David","family":"Kudrow","sequence":"first","affiliation":[{"name":"California Medical Clinic for Headache  Santa Monica California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert S.","family":"Croop","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Thiry","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  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