TY - JOUR
T1 - BMS-927711 for the acute treatment of migraine
T2 - A double-blind, randomized, placebo controlled, dose-ranging trial
AU - Marcus, Ronald
AU - Goadsby, Peter J.
AU - Dodick, David
AU - Stock, David
AU - Manos, George
AU - Fischer, Tanya Z.
N1 - Funding Information:
This study was supported by Bristol-Myers Squibb.
Funding Information:
Drs Marcus, Stock, Manos, and Fischer are current or former employees of Bristol-Myers Squibb. Dr Goadsby is on advisory boards for Allergan, Colucid, MAP pharmaceuticals, Merck, eNeura, Neuraxon, Autonomic Technologies Inc, Boston Scientific, Electrocore, Eli Lilly, Medtronic, Linde gases, Arteaus, AlderBio, and Bristol-Myers Squibb. Dr Goadsby has consulted for Pfizer, Nevrocorp, Lundbeck, Zogenix, Impax and Dr Reddy, and has been compensated for expert legal testimony. Dr Goadsby has grant support from Allergan, Amgen, MAP, and Merck. Dr Goadsby has received honoraria for editorial work from Journal Watch Neurology and for developing educational materials and teaching for the American Headache Society. Dr Dodick has consulted for Allergan, Amgen, Arteaus, Ethicon, Rinat, Colucid, ENeura, NuPathe, Huntsworth, Medlogix, Alder, WL Gore, Y&R, Boston Scientific, Pfizer, Merck, Bristol-Myers Squibb, and MAP. Dr Dodick has received an honorarium from Sage Journals for editorial services.
PY - 2014/2
Y1 - 2014/2
N2 - 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.
AB - 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.
KW - BMS-927711
KW - Calcitonin gene-related peptide
KW - double-blind
KW - migraine
UR - http://www.scopus.com/inward/record.url?scp=84892162373&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84892162373&partnerID=8YFLogxK
U2 - 10.1177/0333102413500727
DO - 10.1177/0333102413500727
M3 - Article
C2 - 23965396
AN - SCOPUS:84892162373
SN - 0333-1024
VL - 34
SP - 114
EP - 125
JO - Cephalalgia
JF - Cephalalgia
IS - 2
ER -