Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial
Rimegepant is a calcitonin gene-related peptide receptor antagonist that has shown efficacy and safety in the acute treatment of migraine. We aimed to compare the efficacy of rimegepant with placebo for preventive treatment of migraine. We did a multicentre, phase 2/3, randomised, double-blind, plac...
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| Veröffentlicht in: | The Lancet (British edition) 2021-01, Vol.397 (10268), p.51-60 |
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| creator | Croop, Robert Lipton, Richard B Kudrow, David Stock, David A Kamen, Lisa Conway, Charles M Stock, Elyse G Coric, Vladimir Goadsby, Peter J |
| description | Rimegepant is a calcitonin gene-related peptide receptor antagonist that has shown efficacy and safety in the acute treatment of migraine. We aimed to compare the efficacy of rimegepant with placebo for preventive treatment of migraine.
We did a multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial at 92 sites in the USA. Adults with at least a 1-year history of migraine were recruited. After a 4-week observation period, eligible participants were randomised using an interactive web response system to oral rimegepant 75 mg or matching placebo every other day for 12 weeks (double-blind treatment phase). The primary efficacy endpoint was change from the 4-week observation period in the mean number of migraine days per month in the last 4 weeks of the double-blind treatment phase (weeks 9–12). Participants who received at least one dose of their assigned study medication and who had 14 days or more of data in the observation period and 14 days or more of data for at least one 4-week interval during the double-blind treatment phase were analysed for efficacy. Those who received at least one dose of study medication were analysed for safety. This study is registered with ClinicalTrials.gov, NCT03732638.
Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or placebo (n=374). 695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated placebo. Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9–12. The change from the observation period in mean number of migraine days per month during weeks 9–12 was −4·3 days (95% CI –4·8 to –3·9) with rimegepant and −3·5 days (–4·0 to –3·0) with placebo (least squares mean difference −0·8 days, 95% CI −1·46 to −0·20; p=0·0099). 741 participants received study medication and were included in the safety analysis. 133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (36%) of 371 who received placebo. Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event; no patients died.
Taken every other day, rimegepant was effective for preventive treatment of migraine. Tolerability was similar to that of placebo, and no unexpected or serious safety issues were |
| doi_str_mv | 10.1016/S0140-6736(20)32544-7 |
| format | Article |
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We did a multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial at 92 sites in the USA. Adults with at least a 1-year history of migraine were recruited. After a 4-week observation period, eligible participants were randomised using an interactive web response system to oral rimegepant 75 mg or matching placebo every other day for 12 weeks (double-blind treatment phase). The primary efficacy endpoint was change from the 4-week observation period in the mean number of migraine days per month in the last 4 weeks of the double-blind treatment phase (weeks 9–12). Participants who received at least one dose of their assigned study medication and who had 14 days or more of data in the observation period and 14 days or more of data for at least one 4-week interval during the double-blind treatment phase were analysed for efficacy. Those who received at least one dose of study medication were analysed for safety. This study is registered with ClinicalTrials.gov, NCT03732638.
Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or placebo (n=374). 695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated placebo. Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9–12. The change from the observation period in mean number of migraine days per month during weeks 9–12 was −4·3 days (95% CI –4·8 to –3·9) with rimegepant and −3·5 days (–4·0 to –3·0) with placebo (least squares mean difference −0·8 days, 95% CI −1·46 to −0·20; p=0·0099). 741 participants received study medication and were included in the safety analysis. 133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (36%) of 371 who received placebo. Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event; no patients died.
Taken every other day, rimegepant was effective for preventive treatment of migraine. Tolerability was similar to that of placebo, and no unexpected or serious safety issues were noted.
Biohaven Pharmaceuticals.</description><identifier>ISSN: 0140-6736</identifier><identifier>ISSN: 1474-547X</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(20)32544-7</identifier><identifier>PMID: 33338437</identifier><language>eng</language><publisher>NEW YORK: Elsevier Ltd</publisher><subject><![CDATA[Administration, Oral ; Adult ; Adverse events ; Analysis ; Calcitonin ; Calcitonin gene-related peptide ; Calcitonin Gene-Related Peptide Receptor Antagonists - therapeutic use ; Clinical trials ; Double-Blind Method ; Double-blind studies ; Drug dosages ; Drug Evaluation ; Drug therapy ; Female ; General & Internal Medicine ; Headache ; Headaches ; Humans ; Interactive systems ; Laboratories ; Life Sciences & Biomedicine ; Male ; Medicine, General & Internal ; Medicine, Preventive ; Migraine ; Migraine Disorders - drug therapy ; Migraine Disorders - prevention & control ; Monoclonal antibodies ; Peptides ; Piperidines - administration & dosage ; Placebos ; Pregnancy ; Prevention ; Preventive health services ; Pyridines - administration & dosage ; Regulatory approval ; Safety ; Science & Technology ; Substance abuse treatment ; Treatment Outcome ; Women]]></subject><ispartof>The Lancet (British edition), 2021-01, Vol.397 (10268), p.51-60</ispartof><rights>2020 Elsevier Ltd</rights><rights>Copyright © 2020 Elsevier Ltd. All rights reserved.</rights><rights>2020. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>199</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000607268300026</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c424t-206245cbf33dae5e9560375dba6d7220014d3a9186043242b00f510d26cff6a3</citedby><cites>FETCH-LOGICAL-c424t-206245cbf33dae5e9560375dba6d7220014d3a9186043242b00f510d26cff6a3</cites><orcidid>0000-0003-3260-5904</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2474456552?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>315,782,786,3552,27931,27932,39265,46002,64392,64394,64396,72476</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33338437$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Croop, Robert</creatorcontrib><creatorcontrib>Lipton, Richard B</creatorcontrib><creatorcontrib>Kudrow, David</creatorcontrib><creatorcontrib>Stock, David A</creatorcontrib><creatorcontrib>Kamen, Lisa</creatorcontrib><creatorcontrib>Conway, Charles M</creatorcontrib><creatorcontrib>Stock, Elyse G</creatorcontrib><creatorcontrib>Coric, Vladimir</creatorcontrib><creatorcontrib>Goadsby, Peter J</creatorcontrib><title>Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial</title><title>The Lancet (British edition)</title><addtitle>LANCET</addtitle><addtitle>Lancet</addtitle><description>Rimegepant is a calcitonin gene-related peptide receptor antagonist that has shown efficacy and safety in the acute treatment of migraine. We aimed to compare the efficacy of rimegepant with placebo for preventive treatment of migraine.
We did a multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial at 92 sites in the USA. Adults with at least a 1-year history of migraine were recruited. After a 4-week observation period, eligible participants were randomised using an interactive web response system to oral rimegepant 75 mg or matching placebo every other day for 12 weeks (double-blind treatment phase). The primary efficacy endpoint was change from the 4-week observation period in the mean number of migraine days per month in the last 4 weeks of the double-blind treatment phase (weeks 9–12). Participants who received at least one dose of their assigned study medication and who had 14 days or more of data in the observation period and 14 days or more of data for at least one 4-week interval during the double-blind treatment phase were analysed for efficacy. Those who received at least one dose of study medication were analysed for safety. This study is registered with ClinicalTrials.gov, NCT03732638.
Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or placebo (n=374). 695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated placebo. Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9–12. The change from the observation period in mean number of migraine days per month during weeks 9–12 was −4·3 days (95% CI –4·8 to –3·9) with rimegepant and −3·5 days (–4·0 to –3·0) with placebo (least squares mean difference −0·8 days, 95% CI −1·46 to −0·20; p=0·0099). 741 participants received study medication and were included in the safety analysis. 133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (36%) of 371 who received placebo. Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event; no patients died.
Taken every other day, rimegepant was effective for preventive treatment of migraine. Tolerability was similar to that of placebo, and no unexpected or serious safety issues were noted.
Biohaven Pharmaceuticals.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Adverse events</subject><subject>Analysis</subject><subject>Calcitonin</subject><subject>Calcitonin gene-related peptide</subject><subject>Calcitonin Gene-Related Peptide Receptor Antagonists - therapeutic use</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Drug Evaluation</subject><subject>Drug therapy</subject><subject>Female</subject><subject>General & Internal Medicine</subject><subject>Headache</subject><subject>Headaches</subject><subject>Humans</subject><subject>Interactive systems</subject><subject>Laboratories</subject><subject>Life Sciences & Biomedicine</subject><subject>Male</subject><subject>Medicine, General & Internal</subject><subject>Medicine, Preventive</subject><subject>Migraine</subject><subject>Migraine Disorders - drug therapy</subject><subject>Migraine Disorders - 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Academic</collection><jtitle>The Lancet (British edition)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Croop, Robert</au><au>Lipton, Richard B</au><au>Kudrow, David</au><au>Stock, David A</au><au>Kamen, Lisa</au><au>Conway, Charles M</au><au>Stock, Elyse G</au><au>Coric, Vladimir</au><au>Goadsby, Peter J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial</atitle><jtitle>The Lancet (British edition)</jtitle><stitle>LANCET</stitle><addtitle>Lancet</addtitle><date>2021-01-02</date><risdate>2021</risdate><volume>397</volume><issue>10268</issue><spage>51</spage><epage>60</epage><pages>51-60</pages><issn>0140-6736</issn><issn>1474-547X</issn><eissn>1474-547X</eissn><abstract>Rimegepant is a calcitonin gene-related peptide receptor antagonist that has shown efficacy and safety in the acute treatment of migraine. We aimed to compare the efficacy of rimegepant with placebo for preventive treatment of migraine.
We did a multicentre, phase 2/3, randomised, double-blind, placebo-controlled trial at 92 sites in the USA. Adults with at least a 1-year history of migraine were recruited. After a 4-week observation period, eligible participants were randomised using an interactive web response system to oral rimegepant 75 mg or matching placebo every other day for 12 weeks (double-blind treatment phase). The primary efficacy endpoint was change from the 4-week observation period in the mean number of migraine days per month in the last 4 weeks of the double-blind treatment phase (weeks 9–12). Participants who received at least one dose of their assigned study medication and who had 14 days or more of data in the observation period and 14 days or more of data for at least one 4-week interval during the double-blind treatment phase were analysed for efficacy. Those who received at least one dose of study medication were analysed for safety. This study is registered with ClinicalTrials.gov, NCT03732638.
Between Nov 14, 2018, and Aug 30, 2019, 1591 participants were recruited and assessed for eligibility, of whom 747 were randomly allocated either rimegepant (n=373) or placebo (n=374). 695 participants were included in the analysis for efficacy, of whom 348 were assigned rimegepant and 347 were allocated placebo. Rimegepant was superior to placebo on the primary endpoint of change in the mean number of migraine days per month during weeks 9–12. The change from the observation period in mean number of migraine days per month during weeks 9–12 was −4·3 days (95% CI –4·8 to –3·9) with rimegepant and −3·5 days (–4·0 to –3·0) with placebo (least squares mean difference −0·8 days, 95% CI −1·46 to −0·20; p=0·0099). 741 participants received study medication and were included in the safety analysis. 133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (36%) of 371 who received placebo. Seven (2%) participants who received rimegepant and four (1%) who received placebo discontinued the study due to an adverse event; no patients died.
Taken every other day, rimegepant was effective for preventive treatment of migraine. Tolerability was similar to that of placebo, and no unexpected or serious safety issues were noted.
Biohaven Pharmaceuticals.</abstract><cop>NEW YORK</cop><pub>Elsevier Ltd</pub><pmid>33338437</pmid><doi>10.1016/S0140-6736(20)32544-7</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-3260-5904</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2021-01, Vol.397 (10268), p.51-60 |
| issn | 0140-6736 1474-547X 1474-547X |
| language | eng |
| recordid | cdi_gale_incontextgauss__A649000735 |
| source | MEDLINE; Web of Science - Science Citation Index Expanded - 2021<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" />; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland |
| subjects | Administration, Oral Adult Adverse events Analysis Calcitonin Calcitonin gene-related peptide Calcitonin Gene-Related Peptide Receptor Antagonists - therapeutic use Clinical trials Double-Blind Method Double-blind studies Drug dosages Drug Evaluation Drug therapy Female General & Internal Medicine Headache Headaches Humans Interactive systems Laboratories Life Sciences & Biomedicine Male Medicine, General & Internal Medicine, Preventive Migraine Migraine Disorders - drug therapy Migraine Disorders - prevention & control Monoclonal antibodies Peptides Piperidines - administration & dosage Placebos Pregnancy Prevention Preventive health services Pyridines - administration & dosage Regulatory approval Safety Science & Technology Substance abuse treatment Treatment Outcome Women |
| title | Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial |
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