1. Brandes JL, Saper JR, Diamond M et al. Topiramate for migra ine prevention: A randomized controlled trial. JAMA 2004; 291: 965-973.
2.
Benschop RJ, Collins EC, Darling RJ, Allan BW, Leung D, Con ner EM et al. Development of a novel antibody to calcitonin gene-related peptide for the treatment of osteoarthritis-re lated pain. Osteoarthr Cartil 2014; 22: 578-585.
3.
Camporeale A, Kudrow D, Sides R, Wang S, Van Dycke A, Selzler KJ et al. A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurol. 2018; 18(1): 188.
4.
Cole JC, Lin P, Rupnow MF. Validation of the Migraine-Spe cific Quality of Life Questionnaire version 2.1 (MSQ v. 2.1) for patients undergoing prophylactic migraine treatment. Qual Life Res 2007; 16: 1231-1237.
5.
Dahlof C, Dimenas E. Migraine patients experience poorer subjective well-being/quality of life even between attacks. Cephalalgia 1995; 15(1): 31-36.
6.
Detke HC, Wang S, Skljarevski V, Ahl J, Millen B, Aurora S et al.A Phase 3 Placebo-Controlled Study of Galcanezumab in Pa tients with Chronic Migraine: Results from the 3-month Dou ble-Blind Treatment Phase of the REGAIN Study 59th Annual Scientific Meeting American Headache Society June 8-11, 2017.
7.
Dodick DW, Freitag F, Banks J, Saper J, Xiang J, Rupnow M et al. Topiramate versus amitriptyline in migraine preven tion: a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs. Clin Ther 2009; 31: 542-559.
8.
Dodick DW, Turkel CC, DeGryse RE, Diener HC, Lipton RB, Aurora SK et al. Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example. J Pain 2015; 16: 164-175.
9.
Eli Lilly and Company. Lilly’s Emgality™ (galcanezumab gnlm) receives U.S. FDA approval for the preventive tre atment of migraine in adults [media release]. 5 Oct 2018a. https://investor.lilly.com/
10.
Eli Lilly and Company. EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use: US prescribing information. 2018. http://pi.lilly.com/. Accessed 11 Oct 2018b.
11.
Ford JH, Ayer DW, Zhang Q, Carter JN, Leroux E, Skljarevski V et al. Two randomized migraine studies of galcanezumab: Ef fects on patient functioning and disability. Neurology 2019; 93(5): e508-e517.
12.
Ford JH, Foster SA, Stauffer VL, Aurora SK, Versijpt J, Satis faction P. Patient satisfaction, health care resource utiliza tion, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine. Patient Prefer Adherence. 2018; 12: 2413-2424.
13.
Förderreuther S, Zhang Q, Stauffer VL, Aurora SK, Láinez MJA. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018; 19(1): 121.
14.
Freitag F. The cycle of migraine: Patients’ quality of life dur ing and between migraine attacks. Clinical Therapy 2007; 29(5): 939-949.
15.
Hepp Z, Bloudek LM, Varon SF. Systematic review of mi graine prophylaxis adherence and persistence. J Manag Care Pharm. 2014; 20: 22-33.
16.
Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al. The American Migraine Prevalence and Prevention Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007; 68: 343-349.
17.
Lipton RB, Varon SF, Grosberg B, McAllister PJ, Freitag F, Aurora SK et al. OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine. Neurology 2011; 77: 1465-1472.
18.
Nichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK. Analysis of Initial Nonresponders to Galcanezumab in Pa tients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Dou ble-Blind, Placebo-Controlled Studies. Headache 2019; 59(2): 192-204.
19.
Oakes TM, Kovacs R, Rosen N, Doty E, Kemmer P, Aurora SK et al. Evaluation of Cardiovascular Outcomes in Adult Patients With Episodic or Chronic Migraine Treated With Galcanezumab: Data From Three Phase 3, Randomized, Dou ble-Blind, Placebo-Controlled EVOLVE-1, EVOLVE-2, and REGAIN Studies. Headache 2020; 60(1): 110-123.
20.
Rendas-Baum R, Bloudek LM, Maglinte GA, Varon SF. The psychometric properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) in chronic migraine patients. Qual Life Res 2013; 22: 1123-1133.
21.
Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E. Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012; 78(17): 1337-1345.
22.
Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N et al. Efficacy and safety of topiramate for the treatment of chronic migraine: A randomized, double-blind, placebo-controlled trial. Headache 2007; 47: 170-180.
23.
Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia 2018; 38(8): 1442-1454.
24.
Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Ep isodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol 2018; 75(9): 1080-1088.
25.
Stauffer VL, Wang S, Voulgaropoulos M, Skljarevski V, Kovacik A, Aurora SK. Effect of Galcanezumab Following Treatment Cessation in Patients With Migraine: Results From 2 Randomized Phase 3 Trials. Headache 2019; 59(6): 834-847.
26.
Stewart WF, Lipton RB, Kolodner K, Liberman J, Sawyer J. Reliability of the Migraine Disability Assessment Score in a population-based sample of headache sufferers. Cepha lalgia 1999; 19: 107-114.
27.
Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) questionnaire to assess headache-related disability. Neurol ogy 2001; 56: S20-S28.
28.
Stępień A, Prusiński A, Suwała A. Wybrane dane epidemiolo giczne występowania migreny w Polsce. Ból 2013; 4(3): 9-12.
29.
The American Headache Society Position Statement On In tegrating New Migraine Treatments Into Clinical Practice. Headache. 2018 Dec 10. doi:10.1111/head.13456
30.
The International Classification of Headache Disorders, 3rd edition. Cephalalgia 2018; 38(1): 1–211.
