Non-headache symptoms are common occurrences during migraines’ prodrome or postdrome phases, the severity of which may affect overall burden of migraine. These symptoms include depression, lethargy and food cravings during the prodrome phase 1, and weakness, tiredness, dizziness, lightheadedness, difficulty concentrating, and decreased energy in the postdrome phase. 2
Preventive treatments currently available do not target prodrome- or postdrome-associated symptoms. 3 A group from the Mayo Clinic Arizona presented studies at the American Headache Society’s 58th Annual Meeting in San Diego, CA, in which they sought to evaluate the effects of TEV-48125, a monoclonal antibody against Calcitonin Gene-Related Peptide (CGRP) on these non-headache symptoms. 4
Previous studies showed TEV-48125 to effectively prevent the headache phase of chronic (CM) and high-frequency episodic migraines (EM) 5, 6. In a post-hoc analysis for Phase 2b clinical trials for use of TEV-48125 in treating CM and high-frequency EM 7-9, researchers evaluated the effects of 2 doses of the antibody on overall ‘wellness’ during headache-free days, and assessed levels of wellness against proximity to headache days.
Wellness was assessed prospectively using electronic headache diaries, and collected on headache-free days. Data collected included ‘the ability to work/study normally, no time spent working more slowly or taking longer to complete tasks, no difficulty concentrating on what needed to be done, no time feeling very tired/asleep/drained, performing household activities normally, being very engaged with partner’s or children’s activities, and being very interested in doing daily activities.’
Study results indicate a significant increase from baseline in headache-free days for the duration of the treatment in patients administered TEV-48125 vs untreated controls. Both doses of TEV-48125 used on EM patients (225 mg and 675 mg), and TEV-48125 at 900 mg for CM-affected individuals showed high statistical significance in improving all aforementioned measures of wellness. For example, the ‘work/study normally’ measure was significantly improved in TEV-48125 treated- vs placebo-treated study participants (EM 225mg P=.0002, 675mg P=.0012; CM 900mg P=.0111).
Results from these clinical trials indicate the effectiveness of TEV-48125 in enhancing overall patient wellness during migraines’ prodrome and postdrome phases. The authors postulate that these improvements are a consequence of interictal symptom alleviation due to the treatment during the migraine’s prodrome phase.
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1.Rozen TD. Migraine prodrome: a nose on a face. Lancet. 2004;363(9408):517.
2.Ng-mak DS, Fitzgerald KA, Norquist JM, et al. Key concepts of migraine postdrome: a qualitative study to develop a post-migraine questionnaire. Headache. 2011;51(1):105-17.
3.Sprenger T, Goadsby PJ. Migraine pathogenesis and state of pharmacological treatment options. BMC Med. 2009;7:71.
4.VanderPluym J, Bigal M, Dodick DW. Abstract OR10. Effect of Monoclonal Calcitonin Gene-Related Peptide Antibody (TEV-48125) on Wellness during Headache Free Days Presented at: 2016 American Headache Society Annual Meeting. June 9-12, 2016; San Diego, CA.
5.Bigal ME, Dodick DW, Krymchantowski AV, et al. TEV-48125 for the preventive treatment of chronic migraine: Efficacy at early time points. Neurology. 2016;
6.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(11):1081-90.