메뉴 건너뛰기




Volumn 14, Issue 11, 2015, Pages 1091-1100

Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: A multicentre, randomised, double-blind, placebo-controlled, phase 2b study

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMIGRAINE AGENT; PLACEBO; TEV 48125; UNCLASSIFIED DRUG; CALCITONIN GENE RELATED PEPTIDE; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

EID: 84944039741     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(15)00245-8     Document Type: Article
Times cited : (235)

References (44)
  • 1
    • 0030758403 scopus 로고    scopus 로고
    • Molecular pharmacology of receptors for calcitonin-gene-related peptide, amylin and adrenomedullin
    • Poyner DR Molecular pharmacology of receptors for calcitonin-gene-related peptide, amylin and adrenomedullin. Biochem Soc Trans 1997, 25:1032-1036.
    • (1997) Biochem Soc Trans , vol.25 , pp. 1032-1036
    • Poyner, D.R.1
  • 2
    • 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. B J Clin Pharmacol 2015, 80:193-199.
    • (2015) B J Clin Pharmacol , vol.80 , pp. 193-199
    • Edvinsson, L.1
  • 3
    • 78649940547 scopus 로고    scopus 로고
    • Possible sites of action of the new calcitonin gene-related peptide receptor antagonists
    • Eftekhari S, Edvinsson L Possible sites of action of the new calcitonin gene-related peptide receptor antagonists. Ther Adv Neurol Disord 2010, 3:369-378.
    • (2010) Ther Adv Neurol Disord , vol.3 , pp. 369-378
    • Eftekhari, S.1    Edvinsson, L.2
  • 4
    • 0035170345 scopus 로고    scopus 로고
    • Calcitonin gene-related peptide (CGRP) and the pathophysiology of headache: therapeutic implications
    • Edvinsson L Calcitonin gene-related peptide (CGRP) and the pathophysiology of headache: therapeutic implications. CNS Drugs 2001, 15:745-753.
    • (2001) CNS Drugs , vol.15 , pp. 745-753
    • Edvinsson, L.1
  • 5
    • 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
  • 6
    • 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
  • 7
    • 77957922955 scopus 로고    scopus 로고
    • CGRP and its receptors provide new insights into migraine pathophysiology
    • Ho TW, Edvinsson L, Goadsby PJ CGRP and its receptors provide new insights into migraine pathophysiology. Nat Rev Neurol 2010, 6:573-582.
    • (2010) Nat Rev Neurol , vol.6 , pp. 573-582
    • Ho, T.W.1    Edvinsson, L.2    Goadsby, P.J.3
  • 8
    • 30044452563 scopus 로고    scopus 로고
    • Calcitonin gene-related peptide antagonists as treatments of migraine and other primary headaches
    • Goadsby PJ Calcitonin gene-related peptide antagonists as treatments of migraine and other primary headaches. Drugs 2005, 65:2557-2567.
    • (2005) Drugs , vol.65 , pp. 2557-2567
    • Goadsby, P.J.1
  • 9
    • 84857084559 scopus 로고    scopus 로고
    • Calcitonin gene-related peptide in migraine: intersection of peripheral inflammation and central modulation
    • Raddant AC, Russo AF Calcitonin gene-related peptide in migraine: intersection of peripheral inflammation and central modulation. Expert Rev Mol Med 2011, 13:e36.
    • (2011) Expert Rev Mol Med , vol.13 , pp. e36
    • Raddant, A.C.1    Russo, A.F.2
  • 10
    • 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
  • 11
    • 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
  • 12
    • 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
  • 13
    • 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
  • 14
    • 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
  • 15
    • 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
  • 16
    • 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
  • 17
    • 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
  • 19
    • 1442265540 scopus 로고    scopus 로고
    • The international classification of headache disorders: 2nd edition
    • 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
  • 20
    • 54749097210 scopus 로고    scopus 로고
    • Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment
    • Bigal ME, Serrano D, Reed M, Lipton RB Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology 2008, 71:559-566.
    • (2008) Neurology , vol.71 , pp. 559-566
    • Bigal, M.E.1    Serrano, D.2    Reed, M.3    Lipton, R.B.4
  • 21
    • 0346106232 scopus 로고    scopus 로고
    • Assessment of migraine disability using the migraine disability assessment (MIDAS) questionnaire: a comparison of chronic migraine with episodic migraine
    • Bigal ME, Rapoport AM, Lipton RB, Tepper SJ, Sheftell FD Assessment of migraine disability using the migraine disability assessment (MIDAS) questionnaire: a comparison of chronic migraine with episodic migraine. Headache 2003, 43:336-342.
    • (2003) Headache , vol.43 , pp. 336-342
    • Bigal, M.E.1    Rapoport, A.M.2    Lipton, R.B.3    Tepper, S.J.4    Sheftell, F.D.5
  • 22
    • 2342480348 scopus 로고    scopus 로고
    • Current and future worldwide prevalence of dependency, its relationship to total population, and dependency ratios
    • Harwood RH, Sayer AA, Hirschfeld M Current and future worldwide prevalence of dependency, its relationship to total population, and dependency ratios. Bull World Health Organ 2004, 82:251-258.
    • (2004) Bull World Health Organ , vol.82 , pp. 251-258
    • Harwood, R.H.1    Sayer, A.A.2    Hirschfeld, M.3
  • 25
    • 77953223552 scopus 로고    scopus 로고
    • OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial
    • Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia 2010, 30:804-814.
    • (2010) Cephalalgia , vol.30 , pp. 804-814
    • Diener, H.C.1    Dodick, D.W.2    Aurora, S.K.3
  • 26
    • 77953194100 scopus 로고    scopus 로고
    • OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial
    • Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 2010, 30:793-803.
    • (2010) Cephalalgia , vol.30 , pp. 793-803
    • Aurora, S.K.1    Dodick, D.W.2    Turkel, C.C.3
  • 27
    • 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
  • 28
    • 84903783970 scopus 로고    scopus 로고
    • Evaluation of cardiovascular parameters in cynomolgus monkeys following IV administration of LBR-101, a monoclonal antibody against calcitonin gene-related peptide
    • Walter S, Alibhoy A, Escandon R, Bigal ME Evaluation of cardiovascular parameters in cynomolgus monkeys following IV administration of LBR-101, a monoclonal antibody against calcitonin gene-related peptide. mAbs 2014, 6:871-878.
    • (2014) mAbs , vol.6 , pp. 871-878
    • Walter, S.1    Alibhoy, A.2    Escandon, R.3    Bigal, M.E.4
  • 29
    • 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
    • published online Sept 30.
    • 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 Neurology 2015, published online Sept 30. http://dx.doi.org/10.1016/S1474-4422(15)00249-5.
    • (2015) Lancet Neurology
    • Bigal, M.E.1    Dodick, D.W.2    Rapoport, A.M.3
  • 30
    • 84879990242 scopus 로고    scopus 로고
    • The International Classification of Headache Disorders, 3rd edition (beta version)
    • The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 2013, 33:629-808. Headache Classification Committee of the International Headache Society (IHS).
    • (2013) Cephalalgia , vol.33 , pp. 629-808
  • 31
    • 84924709870 scopus 로고    scopus 로고
    • TEV-48125: a review of a monoclonal CGRP antibody in development for the preventive treatment of migraine
    • Walter S, Bigal ME TEV-48125: a review of a monoclonal CGRP antibody in development for the preventive treatment of migraine. Curr Pain Headache Rep 2015, 19:476.
    • (2015) Curr Pain Headache Rep , vol.19 , pp. 476
    • Walter, S.1    Bigal, M.E.2
  • 32
    • 84876038240 scopus 로고    scopus 로고
    • Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II)
    • Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache 2013, 53:644-655.
    • (2013) Headache , vol.53 , pp. 644-655
    • Blumenfeld, A.M.1    Bloudek, L.M.2    Becker, W.J.3
  • 33
    • 56749176453 scopus 로고    scopus 로고
    • CGRP function-blocking antibodies inhibit neurogenic vasodilatation without affecting heart rate or arterial blood pressure in the rat
    • Zeller J, Poulsen KT, Sutton JE, et al. CGRP function-blocking antibodies inhibit neurogenic vasodilatation without affecting heart rate or arterial blood pressure in the rat. Br J Pharmacol 2008, 155:1093-1103.
    • (2008) Br J Pharmacol , vol.155 , pp. 1093-1103
    • Zeller, J.1    Poulsen, K.T.2    Sutton, J.E.3
  • 34
    • 0023625890 scopus 로고
    • Transformed or evolutive migraine
    • Mathew NT, Reuveni U, Perez F Transformed or evolutive migraine. Headache 1987, 27:102-106.
    • (1987) Headache , vol.27 , pp. 102-106
    • Mathew, N.T.1    Reuveni, U.2    Perez, F.3
  • 35
    • 0029832047 scopus 로고    scopus 로고
    • Classification of daily and near-daily headaches: field trial of revised IHS criteria
    • Silberstein SD, Lipton RB, Sliwinski M Classification of daily and near-daily headaches: field trial of revised IHS criteria. Neurology 1996, 47:871-875.
    • (1996) Neurology , vol.47 , pp. 871-875
    • Silberstein, S.D.1    Lipton, R.B.2    Sliwinski, M.3
  • 36
    • 84901046526 scopus 로고    scopus 로고
    • Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: results of the phase 1 program
    • Bigal ME, Escandon R, Bronson M, et al. Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: results of the phase 1 program. Cephalalgia 2013, 34:483-492.
    • (2013) Cephalalgia , vol.34 , pp. 483-492
    • Bigal, M.E.1    Escandon, R.2    Bronson, M.3
  • 37
    • 84944102058 scopus 로고    scopus 로고
    • (accessed April 20, 2015).
    • Guidance for industry: assay development for immunogenicity testing of therapeutic proteins US Department of Health and Human Services, Food and Drug AdministrationFood and Drug Administration, Center for Drug Evaluation and Research (CDER)Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)Center for Biologics Evaluation and Research (CBER), (accessed April 20, 2015). http://www.fda.gov/downloads/Drugs/Guidances/UCM192750.pdf.
  • 38
    • 0036657349 scopus 로고    scopus 로고
    • Chronic daily headache: identification of factors associated with induction and transformation
    • Bigal ME, Sheftell FD, Rapoport AM, Tepper SJ, Lipton RB Chronic daily headache: identification of factors associated with induction and transformation. Headache 2002, 42:575-581.
    • (2002) Headache , vol.42 , pp. 575-581
    • Bigal, M.E.1    Sheftell, F.D.2    Rapoport, A.M.3    Tepper, S.J.4    Lipton, R.B.5
  • 39
    • 79952026321 scopus 로고    scopus 로고
    • Rates, predictors, and consequences of remission from chronic migraine to episodic migraine
    • Manack A, Buse DC, Serrano D, Turkel CC, Lipton RB Rates, predictors, and consequences of remission from chronic migraine to episodic migraine. Neurology 2011, 76:711-718.
    • (2011) Neurology , vol.76 , pp. 711-718
    • Manack, A.1    Buse, D.C.2    Serrano, D.3    Turkel, C.C.4    Lipton, R.B.5
  • 40
    • 80054734731 scopus 로고    scopus 로고
    • OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program
    • Aurora SK, Winner P, Freeman MC, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache 2011, 51:1358-1373.
    • (2011) Headache , vol.51 , pp. 1358-1373
    • Aurora, S.K.1    Winner, P.2    Freeman, M.C.3
  • 42
    • 84921485397 scopus 로고    scopus 로고
    • Blood-brain barrier models: in vitro to in vivo translation in preclinical development of CNS-targeting biotherapeutics
    • Stanimirovic DB, Bani-Yaghoub M, Perkins M, Haqqani AS Blood-brain barrier models: in vitro to in vivo translation in preclinical development of CNS-targeting biotherapeutics. Expert Opin Drug Discov 2015, 10:141-155.
    • (2015) Expert Opin Drug Discov , vol.10 , pp. 141-155
    • Stanimirovic, D.B.1    Bani-Yaghoub, M.2    Perkins, M.3    Haqqani, A.S.4
  • 43
    • 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
  • 44
    • 17244383233 scopus 로고    scopus 로고
    • Migraine pathophysiology
    • Goadsby PJ Migraine pathophysiology. Headache 2005, 45(suppl 1):S14-S24.
    • (2005) Headache , vol.45 , pp. S14-S24
    • Goadsby, P.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.