메뉴 건너뛰기




Volumn 15, Issue 4, 2016, Pages 382-390

Safety and efficacy of AMG 334 for prevention of episodic migraine: A randomised, double-blind, placebo-controlled, phase 2 trial

Author keywords

[No Author keywords available]

Indexed keywords

AMG 334; ASPARTATE AMINOTRANSFERASE; CALCITONIN GENE RELATED PEPTIDE RECEPTOR; HUMAN MONOCLONAL ANTIBODY; NEUTRALIZING ANTIBODY; PLACEBO; UNCLASSIFIED DRUG; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

EID: 84960476959     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(16)00019-3     Document Type: Article
Times cited : (311)

References (40)
  • 1
    • 84890876183 scopus 로고    scopus 로고
    • Systematic review of migraine prophylaxis adherence and persistence
    • Hepp Z, Bloudek LM, Varon SF Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm 2014, 20:22-33.
    • (2014) J Manag Care Pharm , vol.20 , pp. 22-33
    • Hepp, Z.1    Bloudek, L.M.2    Varon, S.F.3
  • 2
    • 33846576913 scopus 로고    scopus 로고
    • Migraine prevalence, disease burden, and the need for preventive therapy
    • Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007, 68:343-349.
    • (2007) Neurology , vol.68 , pp. 343-349
    • Lipton, R.B.1    Bigal, M.E.2    Diamond, M.3
  • 3
    • 0025143541 scopus 로고
    • Vasoactive peptide release in the extracerebral circulation of humans during migraine headache
    • Goadsby PJ, Edvinsson L, Ekman R Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol 1990, 28:183-187.
    • (1990) Ann Neurol , vol.28 , pp. 183-187
    • Goadsby, P.J.1    Edvinsson, L.2    Ekman, R.3
  • 4
    • 0027509161 scopus 로고
    • The trigeminovascular system and migraine: studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats
    • Goadsby PJ, Edvinsson L The trigeminovascular system and migraine: studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats. Ann Neurol 1993, 33:48-56.
    • (1993) Ann Neurol , vol.33 , pp. 48-56
    • Goadsby, P.J.1    Edvinsson, L.2
  • 5
    • 78650413846 scopus 로고    scopus 로고
    • Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura
    • Hansen JM, Hauge AW, Olesen J, Ashina M Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura. Cephalalgia 2010, 30:1179-1186.
    • (2010) Cephalalgia , vol.30 , pp. 1179-1186
    • Hansen, J.M.1    Hauge, A.W.2    Olesen, J.3    Ashina, M.4
  • 6
    • 0021981893 scopus 로고
    • Functional role of perivascular peptides in the control of cerebral circulation
    • Edvinnson L Functional role of perivascular peptides in the control of cerebral circulation. Trends Neurosci 1985, 8:126-131.
    • (1985) Trends Neurosci , vol.8 , pp. 126-131
    • Edvinnson, L.1
  • 7
    • 1542346238 scopus 로고    scopus 로고
    • Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine
    • Olesen J, Diener HC, Husstedt IW, et al. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med 2004, 350:1104-1110.
    • (2004) N Engl J Med , vol.350 , pp. 1104-1110
    • Olesen, J.1    Diener, H.C.2    Husstedt, I.W.3
  • 8
    • 57649233374 scopus 로고    scopus 로고
    • 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
    • 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.
    • (2008) Lancet , vol.372 , pp. 2115-2123
    • Ho, T.W.1    Ferrari, M.D.2    Dodick, D.W.3
  • 9
    • 79954607744 scopus 로고    scopus 로고
    • Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine
    • Hewitt DJ, Aurora SK, Dodick DW, et al. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia 2011, 31:712-722.
    • (2011) Cephalalgia , vol.31 , pp. 712-722
    • Hewitt, D.J.1    Aurora, S.K.2    Dodick, D.W.3
  • 10
    • 84892162373 scopus 로고    scopus 로고
    • BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial
    • Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia 2014, 34:114-125.
    • (2014) Cephalalgia , vol.34 , pp. 114-125
    • Marcus, R.1    Goadsby, P.J.2    Dodick, D.3    Stock, D.4    Manos, G.5    Fischer, T.Z.6
  • 11
    • 79953220801 scopus 로고    scopus 로고
    • BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: results from a phase II study
    • Diener HC, Barbanti P, Dahlof C, Reuter U, Habeck J, Podhorna J BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: results from a phase II study. Cephalalgia 2011, 31:573-584.
    • (2011) Cephalalgia , vol.31 , pp. 573-584
    • Diener, H.C.1    Barbanti, P.2    Dahlof, C.3    Reuter, U.4    Habeck, J.5    Podhorna, J.6
  • 12
    • 84907987732 scopus 로고    scopus 로고
    • Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention
    • Ho TW, Connor KM, Zhang Y, et al. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology 2014, 83:958-966.
    • (2014) Neurology , vol.83 , pp. 958-966
    • Ho, T.W.1    Connor, K.M.2    Zhang, Y.3
  • 13
    • 84944059855 scopus 로고    scopus 로고
    • Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study
    • Bigal ME, Dodick DW, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol 2015, 14:1081-1090.
    • (2015) Lancet Neurol , vol.14 , pp. 1081-1090
    • Bigal, M.E.1    Dodick, D.W.2    Rapoport, A.M.3
  • 14
    • 84944039741 scopus 로고    scopus 로고
    • Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study
    • Bigal ME, Edvinsson L, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol 2015, 14:1091-1100.
    • (2015) Lancet Neurol , vol.14 , pp. 1091-1100
    • Bigal, M.E.1    Edvinsson, L.2    Rapoport, A.M.3
  • 15
    • 84907964596 scopus 로고    scopus 로고
    • Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial
    • Dodick DW, Goadsby PJ, Silberstein SD, et al. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol 2014, 13:1100-1107.
    • (2014) Lancet Neurol , vol.13 , pp. 1100-1107
    • Dodick, D.W.1    Goadsby, P.J.2    Silberstein, S.D.3
  • 16
    • 84906262129 scopus 로고    scopus 로고
    • Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study
    • Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol 2014, 13:885-892.
    • (2014) Lancet Neurol , vol.13 , pp. 885-892
    • Dodick, D.W.1    Goadsby, P.J.2    Spierings, E.L.3    Scherer, J.C.4    Sweeney, S.P.5    Grayzel, D.S.6
  • 17
    • 84991204447 scopus 로고    scopus 로고
    • Pharmacological characterization of AMG 334, a potent and selective human monoclonal antibody against the calcitonin gene-related peptide (CGRP) receptor
    • Shi L, Lehto SG, Zhu DX, et al. Pharmacological characterization of AMG 334, a potent and selective human monoclonal antibody against the calcitonin gene-related peptide (CGRP) receptor. J Pharmacol Exp Ther 2016, 356:223-231.
    • (2016) J Pharmacol Exp Ther , vol.356 , pp. 223-231
    • Shi, L.1    Lehto, S.G.2    Zhu, D.X.3
  • 18
    • 84981548564 scopus 로고    scopus 로고
    • Single-dose and multiple dose, phase 1, randomized, double-blind, placebo-controlled studies of AMG 334 in healthy subjects and migraine patients
    • de Hoon JN, Van Hecken A, Yan L, et al. Single-dose and multiple dose, phase 1, randomized, double-blind, placebo-controlled studies of AMG 334 in healthy subjects and migraine patients. Headache 2015, 55(suppl S3):174-175.
    • (2015) Headache , vol.55 , pp. 174-175
    • De Hoon, J.N.1    Van Hecken, A.2    Yan, L.3
  • 19
    • 84981154224 scopus 로고    scopus 로고
    • Characterizing the relationship between AMG 334 concentration and capsaicin-induced increase in dermal blood flow in healthy subjects and migraine patients using pharmacokinetic-pharmacodynamic modeling
    • Vu T, Ma P, Chen J, et al. Characterizing the relationship between AMG 334 concentration and capsaicin-induced increase in dermal blood flow in healthy subjects and migraine patients using pharmacokinetic-pharmacodynamic modeling. Headache 2015, 55(suppl S3):175-176.
    • (2015) Headache , vol.55 , pp. 175-176
    • Vu, T.1    Ma, P.2    Chen, J.3
  • 20
    • 1442265540 scopus 로고    scopus 로고
    • The International Classification of Headache Disorders: 2nd edition
    • Headache Classification Subcommittee of the International Headache Society
    • The International Classification of Headache Disorders: 2nd edition. Cephalalgia 2004, 24(suppl 1):9-160. Headache Classification Subcommittee of the International Headache Society.
    • (2004) Cephalalgia , vol.24 , pp. 9-160
  • 21
    • 1442359548 scopus 로고    scopus 로고
    • Topiramate for migraine prevention: A randomized controlled trial
    • Brandes JL, Saper JR, Diamond M, et al. Topiramate for migraine prevention: a randomized controlled trial. JAMA 2004, 291:965-973.
    • (2004) JAMA , vol.291 , pp. 965-973
    • Brandes, J.L.1    Saper, J.R.2    Diamond, M.3
  • 22
    • 0037062572 scopus 로고    scopus 로고
    • A randomized trial of divalproex sodium extended-release tablets in migraine prophylaxis
    • Freitag FG, Collins SD, Carlson HA, et al. A randomized trial of divalproex sodium extended-release tablets in migraine prophylaxis. Neurology 2002, 58:1652-1659.
    • (2002) Neurology , vol.58 , pp. 1652-1659
    • Freitag, F.G.1    Collins, S.D.2    Carlson, H.A.3
  • 23
    • 84948104998 scopus 로고    scopus 로고
    • Localization of CGRP receptor components and receptor binding sites in rhesus monkey brainstem: a detailed study using in situ hybridization, immunofluorescence, and autoradiography
    • Eftekhari S, Gaspar RC, Roberts R, et al. Localization of CGRP receptor components and receptor binding sites in rhesus monkey brainstem: a detailed study using in situ hybridization, immunofluorescence, and autoradiography. J Comp Neurol 2016, 524:90-118.
    • (2016) J Comp Neurol , vol.524 , pp. 90-118
    • Eftekhari, S.1    Gaspar, R.C.2    Roberts, R.3
  • 24
    • 84937517146 scopus 로고    scopus 로고
    • CGRP receptor antagonists and antibodies against CGRP and its receptor in migraine treatment
    • Edvinsson L CGRP receptor antagonists and antibodies against CGRP and its receptor in migraine treatment. Br J Clin Pharmacol 2015, 80:193-199.
    • (2015) Br J Clin Pharmacol , vol.80 , pp. 193-199
    • Edvinsson, L.1
  • 25
    • 84923335592 scopus 로고    scopus 로고
    • Localization of CGRP, CGRP receptor, PACAP and glutamate in trigeminal ganglion. Relation to the blood-brain barrier
    • Eftekhari S, Salvatore CA, Johansson S, Chen TB, Zeng Z, Edvinsson L Localization of CGRP, CGRP receptor, PACAP and glutamate in trigeminal ganglion. Relation to the blood-brain barrier. Brain Res 2015, 1600:93-109.
    • (2015) Brain Res , vol.1600 , pp. 93-109
    • Eftekhari, S.1    Salvatore, C.A.2    Johansson, S.3    Chen, T.B.4    Zeng, Z.5    Edvinsson, L.6
  • 26
    • 21144435855 scopus 로고    scopus 로고
    • Opening of the blood-brain barrier preceding cortical edema in a severe attack of FHM type II
    • Dreier JP, Jurkat-Rott K, Petzold GC, et al. Opening of the blood-brain barrier preceding cortical edema in a severe attack of FHM type II. Neurology 2005, 64:2145-2147.
    • (2005) Neurology , vol.64 , pp. 2145-2147
    • Dreier, J.P.1    Jurkat-Rott, K.2    Petzold, G.C.3
  • 28
    • 56549109172 scopus 로고    scopus 로고
    • The blood-brain barrier in migraine treatment
    • Edvinsson L, Tfelt-Hansen P The blood-brain barrier in migraine treatment. Cephalalgia 2008, 28:1245-1258.
    • (2008) Cephalalgia , vol.28 , pp. 1245-1258
    • Edvinsson, L.1    Tfelt-Hansen, P.2
  • 29
    • 84886606629 scopus 로고    scopus 로고
    • PET imaging in healthy subjects and migraineurs suggests CGRP receptor antagonists do not have to act centrally to achieve clinical efficacy
    • Vermeersch SGG, de Hoon J, De Saint-Hubert B, et al. PET imaging in healthy subjects and migraineurs suggests CGRP receptor antagonists do not have to act centrally to achieve clinical efficacy. J Headache Pain 2013, 14:P224.
    • (2013) J Headache Pain , vol.14 , pp. P224
    • Vermeersch, S.G.G.1    de Hoon, J.2    De Saint-Hubert, B.3
  • 30
    • 84886024087 scopus 로고    scopus 로고
    • In vivo quantification of calcitonin gene-related peptide receptor occupancy by telcagepant in rhesus monkey and human brain using the positron emission tomography tracer [11C]MK-4232
    • Hostetler ED, Joshi AD, Sanabria-Bohorquez S, et al. In vivo quantification of calcitonin gene-related peptide receptor occupancy by telcagepant in rhesus monkey and human brain using the positron emission tomography tracer [11C]MK-4232. J Pharmacol Exp Ther 2013, 347:478-486.
    • (2013) J Pharmacol Exp Ther , vol.347 , pp. 478-486
    • Hostetler, E.D.1    Joshi, A.D.2    Sanabria-Bohorquez, S.3
  • 31
    • 84940026739 scopus 로고    scopus 로고
    • A second trigeminal CGRP receptor: function and expression of the AMY1 receptor
    • Walker CS, Eftekhari S, Bower RL, et al. A second trigeminal CGRP receptor: function and expression of the AMY1 receptor. Ann Clin Transl Neurol 2015, 2:595-608.
    • (2015) Ann Clin Transl Neurol , vol.2 , pp. 595-608
    • Walker, C.S.1    Eftekhari, S.2    Bower, R.L.3
  • 32
    • 84887643807 scopus 로고    scopus 로고
    • CGRP in the trigeminovascular system: a role for CGRP, adrenomedullin and amylin receptors?
    • Walker CS, Hay DL CGRP in the trigeminovascular system: a role for CGRP, adrenomedullin and amylin receptors?. Br J Pharmacol 2013, 170:1293-1307.
    • (2013) Br J Pharmacol , vol.170 , pp. 1293-1307
    • Walker, C.S.1    Hay, D.L.2
  • 33
    • 84981257146 scopus 로고    scopus 로고
    • Inhibitors of CGRP function differentially affect calcitonin-family ligand/receptor interactions
    • Sun H, Gavva N, Xu C Inhibitors of CGRP function differentially affect calcitonin-family ligand/receptor interactions. Headache 2015, 55(suppl S5):252.
    • (2015) Headache , vol.55 , pp. 252
    • Sun, H.1    Gavva, N.2    Xu, C.3
  • 35
    • 84926452793 scopus 로고    scopus 로고
    • Adherence to oral migraine-preventive medications among patients with chronic migraine
    • Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia 2015, 35:478-488.
    • (2015) Cephalalgia , vol.35 , pp. 478-488
    • Hepp, Z.1    Dodick, D.W.2    Varon, S.F.3    Gillard, P.4    Hansen, R.N.5    Devine, E.B.6
  • 36
    • 2342461018 scopus 로고    scopus 로고
    • Topiramate in migraine prevention: results of a large controlled trial
    • MIGR-001 Study Group
    • Silberstein SD, Neto W, Schmitt J, Jacobs D Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol 2004, 61:490-495. MIGR-001 Study Group.
    • (2004) Arch Neurol , vol.61 , pp. 490-495
    • Silberstein, S.D.1    Neto, W.2    Schmitt, J.3    Jacobs, D.4
  • 37
    • 84946088955 scopus 로고    scopus 로고
    • Onset of efficacy of LY2951742 in migraine prevention: Post-hoc analysis of phase 2a, randomized, double-blind, placebo-controlled study data of a calcitonin gene-related peptide monoclonal antibody
    • Goadsby PJ, Dodick D, Martinez J, et al. Onset of efficacy of LY2951742 in migraine prevention: post-hoc analysis of phase 2a, randomized, double-blind, placebo-controlled study data of a calcitonin gene-related peptide monoclonal antibody. Cephalalgia 2015, 35:55.
    • (2015) Cephalalgia , vol.35 , pp. 55
    • Goadsby, P.J.1    Dodick, D.2    Martinez, J.3
  • 38
  • 39
    • 84908158935 scopus 로고    scopus 로고
    • Cardiovascular and hemodynamic parameters in women following prolonged CGRP inhibition using LBR-101, a monoclonal antibody against CGRP
    • Bigal ME, Walter S, Bronson M, Alibhoy A, Escandon R Cardiovascular and hemodynamic parameters in women following prolonged CGRP inhibition using LBR-101, a monoclonal antibody against CGRP. Cephalalgia 2014, 34:968-976.
    • (2014) Cephalalgia , vol.34 , pp. 968-976
    • Bigal, M.E.1    Walter, S.2    Bronson, M.3    Alibhoy, A.4    Escandon, R.5
  • 40
    • 84857232404 scopus 로고    scopus 로고
    • A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina
    • Chaitman BR, Ho AP, Behm MO, et al. A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina. Clin Pharmacol Ther 2012, 91:459-466.
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 459-466
    • Chaitman, B.R.1    Ho, A.P.2    Behm, M.O.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.