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Open Access 01-12-2023 | Migraine | Research

The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics

Authors: William Kristian Karlsson, Håkan Ashina, Christopher Kjær Cullum, Rune Häckert Christensen, Haidar Muhsen Al-Khazali, Faisal Mohammad Amin, Messoud Ashina, on behalf of the REFORM Investigators

Published in: The Journal of Headache and Pain | Issue 1/2023

Abstract

Background

Erenumab has demonstrated effectiveness for prevention of migraine attacks, but the treatment is costly, and a considerable proportion of patients do not respond to it. The Registry for Migraine study (REFORM) was initiated to discover biomarkers that can predict response to erenumab in patients with migraine. The specific objective was to investigate differences in erenumab efficacy based on clinical information, blood-based biomarkers, structural and functional magnetic resonance imaging (MRI), and response to intravenous infusion of calcitonin gene-related peptide (CGRP). In this first report of the REFORM study, we provide a comprehensive description of the study methodology, and present the baseline characteristics of the study population.

Methods

The REFORM study was a single-center, prospective, longitudinal cohort study in adults with migraine who were scheduled to receive preventive treatment with erenumab as part of a separate, open-label, single-arm phase IV trial. The study included four periods: a 2-week screening period (Weeks -6 to -5), 4-week baseline period (Week -4 to Day 1), 24-week treatment period (Day 1 to Week 24), and a 24-week follow-up period without treatment (Week 25 to Week 48). Demographic and clinical characteristics were recorded using a semi-structured interview, whilst outcome data were obtained using a headache diary, patient-reported outcomes, blood sampling, brain MRI, and responsiveness to intravenous infusion of CGRP.

Results

The study enrolled 751 participants, with a mean age ± SD of 43.8 ± 12.2 years, of which 88.8% (n = 667) were female. At enrollment, 64.7% (n = 486) were diagnosed with chronic migraine, and 30.2% (n = 227) had history of aura. The mean monthly migraine days (MMDs) was 14.5 ± 7.0. Concomitant preventive medications were used by 48.5% (n = 364) of the participants, and 39.9% (n = 300) had failed ≥ 4 preventive medications.

Conclusion

The REFORM study enrolled a population with a high migraine burden and frequent use of concomitant medications. The baseline characteristics were representative of patients with migraine in specialized headache clinics. Future publications will report the results of the investigations presented in this article.

Trial registration

The study and sub-studies were registered on ClinicalTrials.gov (NCT04592952; NCT04603976; and NCT04674020).

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Title: The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics
Authors: William Kristian Karlsson
Håkan Ashina
Christopher Kjær Cullum
Rune Häckert Christensen
Haidar Muhsen Al-Khazali
Faisal Mohammad Amin
Messoud Ashina
on behalf of the REFORM Investigators
Publication date: 01-12-2023
Publisher: Springer Milan
Keywords: Migraine
Erenumab
Magnetic Resonance Imaging
Magnetic Resonance Imaging
Headache
Aura
Biomarkers
Published in: The Journal of Headache and Pain / Issue 1/2023
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI: https://doi.org/10.1186/s10194-023-01604-2

ERS Congress 2024

Springer Medicine

The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics

Abstract

Background

Methods

Results

Conclusion

Trial registration

ERS Congress 2024

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial registration

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