Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine

Cephalalgia

Volumn 31, Issue 6, 2011, Pages 712-722

  Hewitt, David J ^a   Aurora, Sheena K ^b   Dodick, David W ^c   Goadsby, Peter J ^d   Ge, Yang ^a   Bachman, Robert ^a   Taraborelli, Donna ^a   Fan, Xiaoyin ^a   Assaid, Christopher ^a   Lines, Christopher ^a   Ho, Tony W ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Swedish Headache Center   (United States)

^c MAYO CLINIC   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

CGRP; migraine; MK 3207; randomized trial

Indexed keywords

CALCITONIN GENE RELATED PEPTIDE RECEPTOR ANTAGONIST; MK 3207; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AGED; ANALGESIA; ARTICLE; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL DECISION MAKING; MIGRAINE; MULTICENTER STUDY; NAUSEA; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; XEROSTOMIA;

ACUTE DISEASE; ADULT; BICYCLO COMPOUNDS, HETEROCYCLIC; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MIDDLE AGED; MIGRAINE DISORDERS; PLACEBO EFFECT; RECEPTORS, CALCITONIN GENE-RELATED PEPTIDE; SEVERITY OF ILLNESS INDEX; SPIRO COMPOUNDS; TREATMENT OUTCOME;

EID: 79954607744     PISSN: 03331024     EISSN: 14682982     Source Type: Journal    
DOI: 10.1177/0333102411398399     Document Type: Article

References (19)

1. Goadsby PJ, Edvinsson L, Ekman R. Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol. 1990 ; 28: 183-187 (Pubitemid 20244522)
2. Goadsby PJ. Calcitonin gene-related peptide antagonists as treatments of migraine and other primary headaches. Drugs. 2005 ; 65: 2557-2567 (Pubitemid 43049952)
3. Olesen J, Diener HC, Husstedt IW, et al. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Eng J Med. 2004 ; 350: 1104-1110 (Pubitemid 38298990)
4. Ho TW, Mannix LK, Fan X, et al. Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine. Neurology. 2008 ; 70: 1304-1312 (Pubitemid 351550355)
5. Ho TW, Ferrari MD, Dodick DW, et al. Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial. Lancet. 2008 ; 372: 2115-2123
6. Connor KM, Shapiro RE, Diener H-C, et al. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 ; 73: 970-977
7. Ho AP, Dahlöf CGH, Silberstein SD, et al. Randomized, controlled, trial of telcagepant over four migraine attacks. Cephalalgia. 2010 ; 30 (12). 1443-1457
8. Goadsby PJ. Calcitonin gene-related peptide (CGRP) antagonists and migraine- is this a new era?. Neurology. 2008 ; 70: 1300-1301 (Pubitemid 351550335)
9. Dodick D, Lipton RB, Martin V, et al. Consensus statement: cardiovascular safety profile of triptans (5-HT1B/1D agonists) in the acute treatment of migraine. Headache. 2004 ; 44: 414-425 (Pubitemid 38685549)
10. Bell IM, Gallicchio SN, Wood MR, et al. Discovery of MK-3207: a highly potent, orally bioavailable CGRP receptor antagonist. ACS Med Chem Lett. 2010 ; 1: 24-29
11. Salvatore CA, Moore EL, Calamari A, et al. Pharmacological properties of MK-3207, a potent and orally active calcitonin gene-related peptide receptor antagonist. J Pharmacol Exp Ther. 2010 ; 333: 152-160
12. Classification Committee of the International Headache Society . The international classification of headache disorders. 2nd ed. Cephalalgia. 2004 ; 24 (Suppl 1). 9-160
13. Santanello NC, Hartmaier SL, Epstein RS, Silberstein SD. Validation of a new quality of life questionnaire for acute migraine headache. Headache. 1995 ; 35: 330-337
14. Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004 ; 2: 12-12
15. Dodick DW, Sandrini G, Williams P. Use of the sustained pain-free plus no adverse events endpoint in clinical trials of triptans in acute migraine. CNS Drugs. 2007 ; 21: 73-82 (Pubitemid 46072351)
16. Ferrari MD, Roon KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5-HT-1B/1D agonists) in acute migraine treatment: a meta-analysis of 53 trials. Lancet. 2001 ; 358: 1668-1675 (Pubitemid 33124324)
17. Kennedy W, Li CC, Palcza J, et al. Blockade of capsaicin-induced dermal vasodilation (CIDV) by MK-3207, a calcitonin-gene related peptide (CGRP) receptor antagonist for acute treatment of migraine. Cephalalgia. 2009 ; 29: 1357-1357
18. Li C-C, Palcza J, Gipson A, et al. Population prediction of peripheral blockade of capsaicin-induced vasodilation by MK-3207, a calcitonin-gene related peptide (CGRP) receptor antagonist for acute treatment of migraine. J Clin Pharmacol. 2009 ; 49: 1101-1101
19. Merck Sharp & Dohme Corp. 'Merck Updates Status of Clinical Development Programs for Investigational CGRP Receptor Antagonist Treatments for Acute Migraine; MK-3207 Clinical Development Discontinued', press release, 10 September 2009, http://www.merck.com/newsroom/news-release-archive/research-and- development/2009-0910.html (2009, accessed June 2010).