BMS-927711 for the acute treatment of migraine: A double-blind, randomized, placebo controlled, dose-ranging trial

• Published in: Cephalalgia 2014-02, Vol.34 (2), p.114-125
• Main Authors: Marcus, Ronald, Goadsby, Peter J, Dodick, David, Stock, David, Manos, George, Fischer, Tanya Z
• Format: Article
• Language: English
• 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
• ISSN: 0333-1024; 1468-2982
• DOI: 10.1177/0333102413500727

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