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BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial
Background BMS-927711 is a potent, selective, competitive human calcitonin gene-related peptide (CGRP) receptor antagonist that has shown in vivo efficacy without vasoconstrictor effect. The objective of the current study was to determine an effective and tolerable dose range of BMS-927711 for the a...
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| Published in: | Cephalalgia 2014-02, Vol.34 (2), p.114-125 |
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| Main Authors: | , , , , , |
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| cites | cdi_FETCH-LOGICAL-c445t-dfb095addcf7a34f0255467b3b350ea8a6949ff7c31daddace805da7c2d20b483 |
| container_end_page | 125 |
| container_issue | 2 |
| container_start_page | 114 |
| container_title | Cephalalgia |
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| creator | Marcus, Ronald Goadsby, Peter J Dodick, David Stock, David Manos, George Fischer, Tanya Z |
| description | Background
BMS-927711 is a potent, selective, competitive human calcitonin gene-related peptide (CGRP) receptor antagonist that has shown in vivo efficacy without vasoconstrictor effect. The objective of the current study was to determine an effective and tolerable dose range of BMS-927711 for the acute treatment of migraine.
Methods
In this randomized, double-blind, placebo controlled, dose-ranging study, 885 patients were randomized using an adaptive design to one of the following dose groups: BMS-927711 (10, 25, 75, 150, 300, or 600 mg); sumatriptan 100 mg (active comparator); and placebo. Patients were treated for a single migraine attack. The primary endpoint was pain freedom at two hours post-dose.
Results
Of patients who took the study drug, 799 had one post-randomization efficacy evaluation. Significantly more patients in the BMS-927711 75 mg (31.4%, p = 0.002), 150 mg (32.9%, p |
| doi_str_mv | 10.1177/0333102413500727 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_AFRWT</sourceid><recordid>TN_cdi_proquest_miscellaneous_1490743252</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_0333102413500727</sage_id><sourcerecordid>1490743252</sourcerecordid><originalsourceid>FETCH-LOGICAL-c445t-dfb095addcf7a34f0255467b3b350ea8a6949ff7c31daddace805da7c2d20b483</originalsourceid><addsrcrecordid>eNp1kE1P3DAQhq0KVBbae0_IRw41-DNOuG1R-ZBAHNqeI8ceb7Ny4sVODvTX19ECByQOoxnNPPOO5kXoG6PnjGl9QYUQjHLJhKJUc_0JrZisasKbmh-g1TImy_wIHee8pZSqilaf0REXTaVKrFD68fCLNFxrxrCPCU9_ARs7T4CnBGYaYJxw9HjoN8n0I1ziNXZx7gKQLvSj-46TGV0c-n9Q6l0wFrqIbRynFENYei5mIAXa9OOmaPYmfEGH3oQMX1_yCfpz_fP31S25f7y5u1rfEyulmojzHW2Ucc56bYT0lCslK92JrjwLpjZVIxvvtRXMFapcrqlyRlvuOO1kLU7Q2V53l-LTDHlqhz5bCMGMEOfcMtlQLQVXvKB0j9oUc07g213qB5OeW0bbxen2vdNl5fRFfe4GcG8Lr9YWgOyBbDbQbuOcxvLtx4L_AcFghTQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1490743252</pqid></control><display><type>article</type><title>BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial</title><source>SAGE Open Access</source><creator>Marcus, Ronald ; Goadsby, Peter J ; Dodick, David ; Stock, David ; Manos, George ; Fischer, Tanya Z</creator><creatorcontrib>Marcus, Ronald ; Goadsby, Peter J ; Dodick, David ; Stock, David ; Manos, George ; Fischer, Tanya Z</creatorcontrib><description>Background
BMS-927711 is a potent, selective, competitive human calcitonin gene-related peptide (CGRP) receptor antagonist that has shown in vivo efficacy without vasoconstrictor effect. The objective of the current study was to determine an effective and tolerable dose range of BMS-927711 for the acute treatment of migraine.
Methods
In this randomized, double-blind, placebo controlled, dose-ranging study, 885 patients were randomized using an adaptive design to one of the following dose groups: BMS-927711 (10, 25, 75, 150, 300, or 600 mg); sumatriptan 100 mg (active comparator); and placebo. Patients were treated for a single migraine attack. The primary endpoint was pain freedom at two hours post-dose.
Results
Of patients who took the study drug, 799 had one post-randomization efficacy evaluation. Significantly more patients in the BMS-927711 75 mg (31.4%, p = 0.002), 150 mg (32.9%, p < 0.001), and 300 mg (29.7%, p = 0.002) groups and the sumatriptan group (35%, p < 0.001) had pain freedom at two hours post-dose versus placebo (15.3%). For the secondary endpoint of sustained pain freedom from two to 24 hours post-dose, BMS-927711 doses (25–600 mg) were also statistically significant compared with placebo. No deaths or treatment-related serious adverse events (AEs) were reported, and no patients discontinued because of AEs.
Conclusions
BMS-927711 is superior to placebo at several different doses (75 mg, 150 mg, and 300 mg) and has an excellent tolerability profile.</description><identifier>ISSN: 0333-1024</identifier><identifier>EISSN: 1468-2982</identifier><identifier>DOI: 10.1177/0333102413500727</identifier><identifier>PMID: 23965396</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Acute Disease ; Adolescent ; Adult ; Aged ; Calcitonin Gene-Related Peptide - physiology ; Calcitonin Gene-Related Peptide Receptor Antagonists ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Migraine Disorders - drug therapy ; Piperidines - administration & dosage ; Piperidines - adverse effects ; Placebos ; Pyridines - administration & dosage ; Pyridines - adverse effects ; Serotonin 5-HT1 Receptor Agonists - administration & dosage ; Serotonin 5-HT1 Receptor Agonists - adverse effects ; Sumatriptan - administration & dosage ; Sumatriptan - adverse effects ; Treatment Outcome ; Young Adult</subject><ispartof>Cephalalgia, 2014-02, Vol.34 (2), p.114-125</ispartof><rights>International Headache Society 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c445t-dfb095addcf7a34f0255467b3b350ea8a6949ff7c31daddace805da7c2d20b483</citedby><cites>FETCH-LOGICAL-c445t-dfb095addcf7a34f0255467b3b350ea8a6949ff7c31daddace805da7c2d20b483</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/0333102413500727$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/0333102413500727$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>314,780,784,21966,27853,27924,27925,44945,45333</link.rule.ids><linktorsrc>$$Uhttps://journals.sagepub.com/doi/full/10.1177/0333102413500727?utm_source=summon&utm_medium=discovery-provider$$EView_record_in_SAGE_Publications$$FView_record_in_$$GSAGE_Publications</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23965396$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Marcus, Ronald</creatorcontrib><creatorcontrib>Goadsby, Peter J</creatorcontrib><creatorcontrib>Dodick, David</creatorcontrib><creatorcontrib>Stock, David</creatorcontrib><creatorcontrib>Manos, George</creatorcontrib><creatorcontrib>Fischer, Tanya Z</creatorcontrib><title>BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial</title><title>Cephalalgia</title><addtitle>Cephalalgia</addtitle><description>Background
BMS-927711 is a potent, selective, competitive human calcitonin gene-related peptide (CGRP) receptor antagonist that has shown in vivo efficacy without vasoconstrictor effect. The objective of the current study was to determine an effective and tolerable dose range of BMS-927711 for the acute treatment of migraine.
Methods
In this randomized, double-blind, placebo controlled, dose-ranging study, 885 patients were randomized using an adaptive design to one of the following dose groups: BMS-927711 (10, 25, 75, 150, 300, or 600 mg); sumatriptan 100 mg (active comparator); and placebo. Patients were treated for a single migraine attack. The primary endpoint was pain freedom at two hours post-dose.
Results
Of patients who took the study drug, 799 had one post-randomization efficacy evaluation. Significantly more patients in the BMS-927711 75 mg (31.4%, p = 0.002), 150 mg (32.9%, p < 0.001), and 300 mg (29.7%, p = 0.002) groups and the sumatriptan group (35%, p < 0.001) had pain freedom at two hours post-dose versus placebo (15.3%). For the secondary endpoint of sustained pain freedom from two to 24 hours post-dose, BMS-927711 doses (25–600 mg) were also statistically significant compared with placebo. No deaths or treatment-related serious adverse events (AEs) were reported, and no patients discontinued because of AEs.
Conclusions
BMS-927711 is superior to placebo at several different doses (75 mg, 150 mg, and 300 mg) and has an excellent tolerability profile.</description><subject>Acute Disease</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Calcitonin Gene-Related Peptide - physiology</subject><subject>Calcitonin Gene-Related Peptide Receptor Antagonists</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Migraine Disorders - drug therapy</subject><subject>Piperidines - administration & dosage</subject><subject>Piperidines - adverse effects</subject><subject>Placebos</subject><subject>Pyridines - administration & dosage</subject><subject>Pyridines - adverse effects</subject><subject>Serotonin 5-HT1 Receptor Agonists - administration & dosage</subject><subject>Serotonin 5-HT1 Receptor Agonists - adverse effects</subject><subject>Sumatriptan - administration & dosage</subject><subject>Sumatriptan - adverse effects</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0333-1024</issn><issn>1468-2982</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNp1kE1P3DAQhq0KVBbae0_IRw41-DNOuG1R-ZBAHNqeI8ceb7Ny4sVODvTX19ECByQOoxnNPPOO5kXoG6PnjGl9QYUQjHLJhKJUc_0JrZisasKbmh-g1TImy_wIHee8pZSqilaf0REXTaVKrFD68fCLNFxrxrCPCU9_ARs7T4CnBGYaYJxw9HjoN8n0I1ziNXZx7gKQLvSj-46TGV0c-n9Q6l0wFrqIbRynFENYei5mIAXa9OOmaPYmfEGH3oQMX1_yCfpz_fP31S25f7y5u1rfEyulmojzHW2Ucc56bYT0lCslK92JrjwLpjZVIxvvtRXMFapcrqlyRlvuOO1kLU7Q2V53l-LTDHlqhz5bCMGMEOfcMtlQLQVXvKB0j9oUc07g213qB5OeW0bbxen2vdNl5fRFfe4GcG8Lr9YWgOyBbDbQbuOcxvLtx4L_AcFghTQ</recordid><startdate>20140201</startdate><enddate>20140201</enddate><creator>Marcus, Ronald</creator><creator>Goadsby, Peter J</creator><creator>Dodick, David</creator><creator>Stock, David</creator><creator>Manos, George</creator><creator>Fischer, Tanya Z</creator><general>SAGE Publications</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20140201</creationdate><title>BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial</title><author>Marcus, Ronald ; Goadsby, Peter J ; Dodick, David ; Stock, David ; Manos, George ; Fischer, Tanya Z</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c445t-dfb095addcf7a34f0255467b3b350ea8a6949ff7c31daddace805da7c2d20b483</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Acute Disease</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Calcitonin Gene-Related Peptide - physiology</topic><topic>Calcitonin Gene-Related Peptide Receptor Antagonists</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Migraine Disorders - drug therapy</topic><topic>Piperidines - administration & dosage</topic><topic>Piperidines - adverse effects</topic><topic>Placebos</topic><topic>Pyridines - administration & dosage</topic><topic>Pyridines - adverse effects</topic><topic>Serotonin 5-HT1 Receptor Agonists - administration & dosage</topic><topic>Serotonin 5-HT1 Receptor Agonists - adverse effects</topic><topic>Sumatriptan - administration & dosage</topic><topic>Sumatriptan - adverse effects</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Marcus, Ronald</creatorcontrib><creatorcontrib>Goadsby, Peter J</creatorcontrib><creatorcontrib>Dodick, David</creatorcontrib><creatorcontrib>Stock, David</creatorcontrib><creatorcontrib>Manos, George</creatorcontrib><creatorcontrib>Fischer, Tanya Z</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Cephalalgia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Marcus, Ronald</au><au>Goadsby, Peter J</au><au>Dodick, David</au><au>Stock, David</au><au>Manos, George</au><au>Fischer, Tanya Z</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial</atitle><jtitle>Cephalalgia</jtitle><addtitle>Cephalalgia</addtitle><date>2014-02-01</date><risdate>2014</risdate><volume>34</volume><issue>2</issue><spage>114</spage><epage>125</epage><pages>114-125</pages><issn>0333-1024</issn><eissn>1468-2982</eissn><abstract>Background
BMS-927711 is a potent, selective, competitive human calcitonin gene-related peptide (CGRP) receptor antagonist that has shown in vivo efficacy without vasoconstrictor effect. The objective of the current study was to determine an effective and tolerable dose range of BMS-927711 for the acute treatment of migraine.
Methods
In this randomized, double-blind, placebo controlled, dose-ranging study, 885 patients were randomized using an adaptive design to one of the following dose groups: BMS-927711 (10, 25, 75, 150, 300, or 600 mg); sumatriptan 100 mg (active comparator); and placebo. Patients were treated for a single migraine attack. The primary endpoint was pain freedom at two hours post-dose.
Results
Of patients who took the study drug, 799 had one post-randomization efficacy evaluation. Significantly more patients in the BMS-927711 75 mg (31.4%, p = 0.002), 150 mg (32.9%, p < 0.001), and 300 mg (29.7%, p = 0.002) groups and the sumatriptan group (35%, p < 0.001) had pain freedom at two hours post-dose versus placebo (15.3%). For the secondary endpoint of sustained pain freedom from two to 24 hours post-dose, BMS-927711 doses (25–600 mg) were also statistically significant compared with placebo. No deaths or treatment-related serious adverse events (AEs) were reported, and no patients discontinued because of AEs.
Conclusions
BMS-927711 is superior to placebo at several different doses (75 mg, 150 mg, and 300 mg) and has an excellent tolerability profile.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>23965396</pmid><doi>10.1177/0333102413500727</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0333-1024 |
| ispartof | Cephalalgia, 2014-02, Vol.34 (2), p.114-125 |
| issn | 0333-1024 1468-2982 |
| language | eng |
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| source | SAGE Open Access |
| subjects | Acute Disease Adolescent Adult Aged Calcitonin Gene-Related Peptide - physiology Calcitonin Gene-Related Peptide Receptor Antagonists Dose-Response Relationship, Drug Double-Blind Method Female Humans Male Middle Aged Migraine Disorders - drug therapy Piperidines - administration & dosage Piperidines - adverse effects Placebos Pyridines - administration & dosage Pyridines - adverse effects Serotonin 5-HT1 Receptor Agonists - administration & dosage Serotonin 5-HT1 Receptor Agonists - adverse effects Sumatriptan - administration & dosage Sumatriptan - adverse effects Treatment Outcome Young Adult |
| title | BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial |
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