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Guideline
. 2019 May;39(6):687-710.
doi: 10.1177/0333102419828967. Epub 2019 Feb 26.

Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition

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Guideline

Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition

Hans-Christoph Diener et al. Cephalalgia. 2019 May.

Abstract

The quality of clinical trials is an essential part of the evidence base for the treatment of headache disorders. In 1991, the International Headache Society Clinical Trials Standing Committee developed and published the first edition of the Guidelines for controlled trials of drugs in migraine. Scientific and clinical developments in headache medicine led to second and third editions in 2000 and 2012, respectively. The current, fourth edition of the Guidelines retains the structure and much content from previous editions. However, it also incorporates evidence from clinical trials published after the third edition as well as feedback from meetings with regulators, pharmaceutical and device manufacturers, and patient associations. Its final form reflects the collective expertise and judgement of the Committee. These updated recommendations and commentary are intended to meet the Society's continuing objective of providing a contemporary, standardized, and evidence-based approach to the conduct and reporting of randomised controlled trials for the acute treatment of migraine attacks.

Keywords: Guidelines; acute treatment of migraine attacks in adults; controlled trials.

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References

    1. International Headache Society Committee on Clinical Trials in Migraine. Guidelines for controlled trials of drugs in migraine. Cephalalgia 1991; 11: 1–12. - PubMed
    1. Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine: Second edition. Cephalalgia 2000; 20: 765–786. - PubMed
    1. Tfelt-Hansen P, Pascual J, Ramadan N, et al. Guidelines for controlled trials of drugs in migraine: Third edition. A guide for investigators. Cephalalgia 2012; 32: 6–38. - PubMed
    1. US Food and Drug Administration, Center for Drug Evaluation and Research. Migraine: Developing drugs for acute treatment guidance for industry, https://www.fda.gov/downloads/drugs/guidances/ucm419465.pdf (February 2018).
    1. European Medicines Agency. Concept paper on the need for revision of the guideline on clinical investigation of medicinal product for the treatment of migraine, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin... (13 October 2016).

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