Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults

Background Quality clinical trials form 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. In 2008, the Committee published the first specific guidelines on chronic migraine. Subsequent advances in drug, device, and biologicals development, as well as novel trial designs, have created a need for a revision of the chronic migraine guidelines. Objective The present update is intended to optimize the design of controlled trials of preventive treatment of chronic migraine in adults, and its recommendations do not apply to trials in children or adolescents.

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Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults

Cephalalgia ◽

10.1177/0333102420941839 ◽

2020 ◽

Vol 40 (10) ◽

pp. 1026-1044 ◽

Cited By ~ 2

Author(s):

Hans-Christoph Diener ◽

Cristina Tassorelli ◽

David W Dodick ◽

Stephan D Silberstein ◽

Richard B Lipton ◽

...

Keyword(s):

Clinical Trials ◽

Acute Treatment ◽

International Headache Society ◽

Preventive Treatment ◽

Evidence Base ◽

Episodic Migraine ◽

Controlled Trials ◽

Headache Disorders ◽

Standing Committee ◽

New Research

Clinical trials are a key component 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. Advances in drugs, devices, and biologicals, as well as novel trial designs, have prompted several updates over the nearly 30 years since, including most recently the Guidelines for controlled trials of preventive treatment of chronic migraine (2018), the Guidelines for controlled trials of acute treatment of migraine attacks in adults (2019), and Guidelines for controlled trials of preventive treatment of migraine in children and adolescents (2019). The present update incorporates findings from new research and is intended to optimize the design of controlled trials of preventive pharmacological treatment of episodic migraine in adults. A guideline for clinical trials with devices will be published separately.

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

Cephalalgia ◽

10.1177/0333102419828967 ◽

2019 ◽

Vol 39 (6) ◽

pp. 687-710 ◽

Cited By ~ 28

Author(s):

Hans-Christoph Diener ◽

Cristina Tassorelli ◽

David W Dodick ◽

Stephen D Silberstein ◽

Richard B Lipton ◽

...

Keyword(s):

Clinical Trials ◽

Acute Treatment ◽

International Headache Society ◽

Evidence Base ◽

Controlled Trials ◽

Headache Disorders ◽

Fourth Edition ◽

Standing Committee ◽

Randomised Controlled

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.

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Adherence to the 2008 IHS guidelines for controlled trials of drugs for the preventive treatment of chronic migraine in adults

Cephalalgia ◽

10.1177/0333102419847751 ◽

2019 ◽

Vol 39 (8) ◽

pp. 1058-1066 ◽

Cited By ~ 1

Author(s):

Marie Deen ◽

Daniele Martinelli ◽

Judith Pijpers ◽

Hans-Christoph Diener ◽

Stephen Silberstein ◽

...

Keyword(s):

Clinical Trials ◽

Chronic Migraine ◽

International Headache Society ◽

A Priori ◽

Preventive Treatment ◽

Controlled Clinical Trials ◽

Trial Quality ◽

Definition Of ◽

Double Blinded

Introduction Since the definition of chronic migraine as a new disease entity in 2004, numerous clinical trials have examined the efficacy of preventive treatments in chronic migraine. Our aim was to assess the adherence of these trials to the Guidelines of the International Headache Society published in 2008. Methods We searched PubMed for controlled clinical trials investigating preventive treatment for chronic migraine in adults designed after the release of the Guidelines and published until December 2017. Trial quality was evaluated with a 13-item scoring system enlisting essential recommendations adapted from the Guidelines. Results Out of 3352 retrieved records, we included 16 papers in the analysis dealing with pharmacological treatment of chronic migraine. The median score was 6.5 (range 2–13). All trials were randomized, the large majority (81.25%) were placebo-controlled and double-blinded (87.5%). Adherence was lowest on i) a priori definition of outcomes (31.25%), ii) primary endpoint definition (37.5%%) and iii) trial registration (37.5%). Discussion Most clinical trials adhered to the recommendations of the IHS, whereas adherence to migraine-specific recommendations was lower. Greater awareness and adherence to the guidelines are essential to improve the quality of clinical trials, validity of publications and the generalizability of the results.

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Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition

Cephalalgia ◽

10.1177/0333102419842188 ◽

2019 ◽

Vol 39 (7) ◽

pp. 803-816 ◽

Cited By ~ 6

Author(s):

Ishaq Abu-Arafeh ◽

Andrew D Hershey ◽

Hans-Christoph Diener ◽

Cristina Tassorelli ◽

Keyword(s):

Clinical Trials ◽

Children And Adolescents ◽

International Headache Society ◽

Preventive Treatment ◽

Evidence Base ◽

Prescribing Patterns ◽

Evidence Based ◽

Behavioural Interventions ◽

Multiple Issues ◽

Regulatory Bodies

Background Because the results of clinical trials of investigational treatments influence regulatory policy, prescribing patterns, and use in clinical practice, high quality trials are an essential component of the evidence base for migraine. The International Headache Society has published guidelines for clinical trials in adults with migraine since 1991. With multiple issues specific to children and adolescents with migraine, as well as the emergence of novel trial designs and advances in pharmaceuticals, biologics, devices, and behavioural interventions, there is a need for guidance focusing on issues specific to the conduct of clinical trials in children and adolescents with migraine. Objectives The objective of these guidelines is to provide a contemporary, standardized, and evidence-based approach to the design, conduct, and reporting of well-controlled clinical trials of preventive treatment of migraine in children and adolescents. Methods The development of these guidelines was based on guidelines previously published by the International Headache Society and regulatory bodies. The recommendations are evidence-based, where available. The process included consultations among various committees, roundtable discussions among stakeholders (lay people and the pharmaceutical industry), and open consultation with the IHS membership on the final draft. Results A series of recommendations addressing the major issues in clinical trials in children and adolescents with migraine is provided. Recommendations are supported by evidence-based practice and validated methodologies, where available. Supporting comments are provided to clarify ambiguities. Conclusions These guidelines should be consulted and used in designing and conducting clinical trials of preventive treatments in children and adolescents with migraine.

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Guidelines for Controlled Trials of Prophylactic Treatment of Chronic Migraine in Adults

Cephalalgia ◽

10.1111/j.1468-2982.2008.01555.x ◽

2008 ◽

Vol 28 (5) ◽

pp. 484-495 ◽

Cited By ~ 203

Author(s):

S Silberstein ◽

P Tfelt-Hansen ◽

DW Dodick ◽

V Limmroth ◽

RB Lipton ◽

...

Keyword(s):

Clinical Trials ◽

Chronic Migraine ◽

Prophylactic Treatment ◽

International Headache Society ◽

Current Trend ◽

Episodic Migraine ◽

Controlled Trials ◽

Controlled Clinical Trials ◽

Methodological Issues

In 1991 the Clinical Trials Subcommittee of the International Headache Society (IHS) developed and published its first edition of the Guidelines on controlled trials of drugs in episodic migraine because only quality trials can form the basis for international collaboration on drug therapy, and these Guidelines would ‘improve the quality of controlled clinical trials in migraine’. With the current trend for large multinational trials, there is a need for increased awareness of methodological issues in clinical trials of drugs and other treatments for chronic migraine. These Guidelines are intended to assist in the design of well-controlled clinical trials of chronic migraine in adults, and do not apply to studies in children or adolescents.

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Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

Cephalalgia ◽

10.1177/03331024211010413 ◽

2021 ◽

pp. 033310242110104

Author(s):

Cristina Tassorelli ◽

Hans-Christoph Diener ◽

Stephen D Silberstein ◽

David W Dodick ◽

Peter J Goadsby ◽

...

Keyword(s):

Clinical Trials ◽

International Headache Society ◽

Preventive Treatment ◽

European Medicines Agency ◽

Migraine Treatment ◽

Controlled Trials ◽

The Us ◽

Clinical Benefits ◽

Expert Analysis ◽

Key Terms

Background Although the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and/or preventive treatment of migraine. Methods An international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine. Results Key terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created. Conclusions Adoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.

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Treatment Options for Vestibular Migraine

US Neurology ◽

10.17925/usn.2016.12.01.39 ◽

2016 ◽

Vol 12 (01) ◽

pp. 39 ◽

Cited By ~ 1

Author(s):

Steffen Naegel ◽

◽

Manjit Matharu ◽

Mark Obermann ◽

◽

...

Keyword(s):

Prophylactic Treatment ◽

International Headache Society ◽

Controlled Trial ◽

Treatment Options ◽

Evidence Base ◽

Vestibular Migraine ◽

Controlled Trials ◽

Common Cause ◽

Randomized Controlled ◽

Trial Testing

Although vestibular migraine is a common cause of vertigo, affecting approximately 1% of the Western world’s population, it remains widely under-recognized and is under-diagnosed. Diagnostic criteria for vestibular migraine were recently published in collaboration with the International Headache Society and the Bárány-Society. Trials investigating the treatment of vestibular migraine are sparse but some are now underway. This review focuses on the treatments options available for vestibular migraine, based on the existing evidence base where available. Regarding acute treatments, there are two randomized controlled trials that provide evidence for the use of triptans (zolmitriptan and rizatriptan) for the management of vestibular migraine attacks. For prophylactic treatment, the evidence base is largely non-existent, since the only multicenter randomized placebo-controlled trial testing metoprolol versus placebo is still underway. Consequently, the treatment recommendations for the prophylactic treatment of vestibular migraine are mainly based on expert opinion and the treatments guidelines for migraine with and without aura.

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Guidelines for Controlled Trials of Drugs in Migraine. First Edition

Cephalalgia ◽

10.1046/j.1468-2982.1991.1101001.x ◽

1991 ◽

Vol 11 (1) ◽

pp. 1-12 ◽

Cited By ~ 121

Keyword(s):

Clinical Trials ◽

International Headache Society ◽

Controlled Trials ◽

English Version ◽

Society Committee

The copyrights of this document belong to the International Headache Society Committee on Clinical Trials in Migraine. This document is not copyrighted in the English version provided the source is acknowledged. Translations to other languages must be authorized by a national headache society associated with the International Headache Society.

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The International Classification of Headache Disorders Revised Criteria for Chronic Migraine—Field Testing in a Headache Specialty Clinic

Cephalalgia ◽

10.1111/j.1468-2982.2006.01274.x ◽

2007 ◽

Vol 27 (3) ◽

pp. 230-234 ◽

Cited By ~ 51

Author(s):

ME Bigal ◽

AM Rapoport ◽

FD Sheftell ◽

SJ Tepper ◽

RB Lipton

Keyword(s):

Chronic Migraine ◽

Medication Overuse ◽

International Headache Society ◽

Medication Overuse Headache ◽

Biological Marker ◽

International Classification ◽

Headache Disorders ◽

Transformed Migraine ◽

Probable Migraine

In the absence of a biological marker and expert consensus on the best approach to classify chronic migraine (CM), recent revised criteria for this disease has been proposed by the Headache Classification Committee of the International Headache Society. This revised criteria for CM is now presented in the Appendix. Herein we field test the revised criteria for CM. We included individuals with transformed migraine with or without medication overuse (TM+ and TM-), according to the criteria proposed by Silberstein and Lipton, since this criterion has been largely used before the Second Edition of the International Classification of the Headache Disorders (ICHD-2). We assessed the proportion of subjects that fulfilled ICHD-2 criteria for CM or probable chronic migraine with probable medication overuse (CM+), as well as the revised ICHD-2 (ICHD-2R) criteria for CM (≥15 days of headache, ≥8 days of migraine or migraine-specific acute medication use—ergotamine or triptans). We also tested the ICHD-2R vs. three proposals. In proposal 1, CM/CM+ would require at least 15 days of migraine or probable migraine per month. Proposal 2 required ≥15 days of headache per month and at least 50% of these days were migraine or probable migraine. Proposal 3 required ≥15 days of headache and at least 8 days of migraine or probable migraine per month. Of the 158 patients with TM-, just 5.6% met ICHD-2 criteria for CM. According to the ICHD-2R, a total of 92.4% met criteria for CM ( P < 0.001 vs. ICHD-2). The ICHD-2R criterion performed better than proposal 1 (47.8% of agreement, P < 0.01) and was not statistically different from proposals 2 (87.9%) and 3 (94.9%). Subjects with TM+ should be classified as medication overuse headache (MOH), and not CM+, according to the ICHD-2R. Nonetheless, we assessed the proportion of them who had ≥8 days of migraine per month. Of the 399 individuals with TM+, just 10.2% could be classified as CM+ in the ICHD-2. However, most (349, 86.9%) had ≥8 days of migraine per month and could be classified as MOH and probable CM in the ICHD-2R ( P < 0.001 vs. ICHD-2). We conclude that the ICHD-2R addresses most of the criticism towards the ICHD-2 and should be adopted in clinical practice and research. In the population where use of specific acute migraine medications is less common, the agreement between ICHD-2R CM and TM may be less robust.

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