Systematic review of outcomes and endpoints in preventive migraine clinical trials

McGinley, James S.; Houts, Carrie R.; Nishida, Tracy; Buse, Dawn C.; Lipton, Richard B.; Goadsby, PJ; Dodick, David W.; Wirth, R.

doi:10.1111/head.14069

Cited by 35 publications

(49 citation statements)

References 22 publications

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“…Patients with migraine balance lifestyle changes and trigger management with acute and preventive treatments taken to stop an attack or reduce the overall frequency of attacks [10][11][12]. In clinical trials for acute and preventive treatment of migraine, various endpoints and patient-reported outcome measures (PROMs) are used to evaluate efficacy [13,14].…”

Section: Introductionmentioning

confidence: 99%

Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study

et al. 2022

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Background Demonstrating therapeutic value from the patient perspective is important in patient-centered migraine management. The objective of this study was to investigate the impact of eptinezumab, a preventive migraine treatment, on patient-reported headache impact, acute medication optimization, and perception of disease change when initiated during a migraine attack. Methods RELIEF was a randomized, double-blind, placebo-controlled trial conducted between 2019 and 2020 in adults with ≥1-year history of migraine and 4–15 migraine days per month in the 3 months prior to screening. Patients were randomized (1:1) to a 30-min infusion of eptinezumab 100 mg or placebo within 1–6 h of a qualifying migraine attack onset. The 6-item Headache Impact Test (HIT-6) and 6-item Migraine Treatment Optimization Questionnaire (mTOQ-6) were administered at baseline and week 4, and the Patient Global Impression of Change (PGIC) at week 4. A post hoc analysis of these measures was conducted in patients who reported headache pain freedom at 2 h after infusion start. Results Of 480 patients enrolled and treated, 476 completed the study and are included in this analysis. Mean baseline HIT-6 total scores indicated severe headache impact (eptinezumab, 65.1; placebo, 64.8). At week 4, the eptinezumab-treated group demonstrated clinically meaningful improvement in HIT-6 total score compared with placebo (mean change from baseline: eptinezumab, − 8.7; placebo, − 4.5; mean [95% CI] difference from placebo: − 4.2 [− 5.75, − 2.63], P < .0001), with greater reductions in each item score vs placebo (P < .001 all comparisons). Change in HIT-6 total score in the subgroup with 2-h headache pain freedom was − 13.8 for the eptinezumab group compared with − 4.9 for the placebo group. mTOQ-6 total score mean change from baseline favored eptinezumab (change, 2.1) compared with placebo (1.2; mean [95% CI] difference: 0.9 [0.3, 1.5], P < .01). More eptinezumab-treated patients rated PGIC as much or very much improved than placebo patients (59.3% vs 25.9%). Conclusions When administered during a migraine attack, eptinezumab significantly improved patient-reported outcomes after 4 weeks compared with placebo, with particularly pronounced effects in patients reporting headache pain freedom at 2 h after infusion start. Trial registration ClinicalTrials.gov Identifier: NCT04152083. November 5, 2019.

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Section: Introductionmentioning

confidence: 99%

Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study

et al. 2022

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“…Further understanding of the impact of stigma on the lived experience of migraine is also critical to ensure that patients do not feel judged for their migraine‐induced debilitations or lessen their self‐worth due to their disease 34,37 . As reflected by recent expert international consensus 44 and systematic reviews, 45,46 clinical trials should always include outcomes that reflect the full impact of migraine on patient lives through assessing both disability and quality of life. Both disability and quality of life are worthy of being a primary outcome, including for pharmacological treatments as well as for implementation science and nonpharmacological treatment approaches 20,44,47 …”

Section: Discussionmentioning

confidence: 99%

Learning the full impact of migraine through patient voices: A qualitative study

et al. 2021

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Objective: To better characterize the ways that migraine affects multiple domains of life.Background: Further understanding of migraine burden is needed. Methods: Adults with migraine randomized to mindfulness-based stress reduction or headache education arms (n = 81) in two separate randomized clinical trials participated in semistructured in-person qualitative interviews conducted after the interventions. Interviews queried participants on migraine impact on life and were audio-recorded, transcribed, and summarized into a framework matrix. A master codebook was created until meaning saturation was reached and magnitude coding established code frequency. Themes and subthemes were identified using a constructivist grounded theory approach. Results: Despite most participants being treated with acute and/or prophylactic medications, 90% (73/81) reported migraine had a negative impact on overall life, with 68% (55/81) endorsing specific domains of life impacted and 52% (42/81) describing impact on emotional health. Six main themes of migraine impact emerged: (1) global negative impact on overall life; (2) impact on emotional health; (3) impact on cognitive function; (4) impact on specific domains of life (work/career, family, social); (5) fear and avoidance (pain catastrophizing and anticipatory anxiety); and (6) internalized and externalized stigma. Participants reported how migraine (a) controls life, (b) makes life How to cite this article:

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“…Patient-reported outcome measures (PROMs) play an increasingly important role in the field of neurology, particularly in headache medicine (10)(11)(12)23). There are several PROMs currently seeing wide use in headache studies and clinical trials, such as the Migraine Disability Assessment Test (MIDAS), the 6-item Headache Impact Test (HIT-6), the Migraine-specific Quality of Life Questionnaire (MSQ) (24)(25)(26)(27)(28)(29). These existing PROMs provide valuable insights on domains such as headache-related disability and quality of life.…”

Section: Discussionmentioning

confidence: 99%

Measuring headache day severity using multiple features in daily diary designs

et al. 2021

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Objective Though migraine is thought of as a symptom complex, symptoms are typically assessed one at a time. For use in clinical research, we developed a composite measure of headache day severity by combining eight well-known symptoms captured in daily diaries. Subjects and Methods Data came from adults with a self-reported diagnosis of migraine (n = 4380) who provided daily diary information assessed using a novel digital platform. Nine observed features theoretically linked to headache day severity were analyzed using latent variable modeling to create a psychometrically robust headache day severity score. Logistic regression was used to assess the cross-sectional relationships of headache day severity scores against an array of clinically-relevant outcomes. Results Participants were largely females (90%), approaching middle age (mean age of 37.3) and living in the United States (49%) or United Kingdom (23%). Findings supported a single latent headache day severity construct based on eight observed headache features. Headache day severity scores were associated with an increased odds of physician visits (Odds ratio[95% CI]: 1.71[1.32–2.21]), emergency department visits (4.12[2.23-7.60]), missed school/work (2.90[2.56–3.29]), missed household work (3.37[3.06–3.72]), and missed other activities (3.29[2.97–3.64]) (p < .0001 for all). Conclusions Modern measurement techniques support a single headache day severity construct that reflects migraine is a symptom complex. The headache day severity scores were associated with external validators and initial visualizations showed how headache day severity scores can be applied broadly in clinical practice and research.

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Systematic review of outcomes and endpoints in preventive migraine clinical trials

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Cited by 35 publications

References 22 publications

Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study

Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study

Learning the full impact of migraine through patient voices: A qualitative study

Measuring headache day severity using multiple features in daily diary designs

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