PMID- 23965396
OWN - NLM
STAT- MEDLINE
DCOM- 20140904
LR  - 20220409
IS  - 1468-2982 (Electronic)
IS  - 0333-1024 (Linking)
VI  - 34
IP  - 2
DP  - 2014 Feb
TI  - BMS-927711 for the acute treatment of migraine: a double-blind, randomized, 
      placebo controlled, dose-ranging trial.
PG  - 114-25
LID - 10.1177/0333102413500727 [doi]
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.
FAU - Marcus, Ronald
AU  - Marcus R
AD  - Bristol-Myers Squibb, Wallingford, CT, USA.
FAU - Goadsby, Peter J
AU  - Goadsby PJ
FAU - Dodick, David
AU  - Dodick D
FAU - Stock, David
AU  - Stock D
FAU - Manos, George
AU  - Manos G
FAU - Fischer, Tanya Z
AU  - Fischer TZ
LA  - eng
SI  - ClinicalTrials.gov/NCT01430442
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130821
PL  - England
TA  - Cephalalgia
JT  - Cephalalgia : an international journal of headache
JID - 8200710
RN  - 0 (Calcitonin Gene-Related Peptide Receptor Antagonists)
RN  - 0 (Piperidines)
RN  - 0 (Placebos)
RN  - 0 (Pyridines)
RN  - 0 (Serotonin 5-HT1 Receptor Agonists)
RN  - 1383NM3Q0H (rimegepant sulfate)
RN  - 8R78F6L9VO (Sumatriptan)
RN  - JHB2QIZ69Z (Calcitonin Gene-Related Peptide)
SB  - IM
CIN - Cephalalgia. 2014 Oct;34(12):1028-9. PMID: 24615704
CIN - Cephalalgia. 2015 Apr;35(4):366-7. PMID: 25022695
MH  - Acute Disease
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Calcitonin Gene-Related Peptide/*physiology
MH  - *Calcitonin Gene-Related Peptide Receptor Antagonists
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*drug therapy
MH  - Piperidines/*administration & dosage/adverse effects
MH  - Placebos
MH  - Pyridines/*administration & dosage/adverse effects
MH  - Serotonin 5-HT1 Receptor Agonists/administration & dosage/adverse effects
MH  - Sumatriptan/administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - BMS-927711
OT  - Calcitonin gene-related peptide
OT  - double-blind
OT  - migraine
EDAT- 2013/08/24 06:00
MHDA- 2014/09/05 06:00
CRDT- 2013/08/23 06:00
PHST- 2013/08/23 06:00 [entrez]
PHST- 2013/08/24 06:00 [pubmed]
PHST- 2014/09/05 06:00 [medline]
AID - 0333102413500727 [pii]
AID - 10.1177/0333102413500727 [doi]
PST - ppublish
SO  - Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 
      21.