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

GND
1143864190
ORCID
0000-0003-1252-0153
Affiliation
Paediatric Neurosciences Unit, Royal Hospital for Children, Glasgow, UK
Abu-Arafeh, Ishaq;
ORCID
0000-0002-1598-7536
Affiliation
Department of Pediatrics and Neurology, Cincinnati Children's Hospital, University of Cincinnati, College of Medicine, Cincinnati, OH, USA
Hershey, Andrew D.;
GND
11811901X
ORCID
0000-0002-6556-8612
LSF
13450
Affiliation
Department of Neurology, University Hospital Essen, Essen, Germany
Diener, Hans-Christoph;
ORCID
0000-0003-1513-2113
Affiliation
Headache Science Center, IRCCS C. Mondino Foundation, Pavia, Italy
Tassorelli, Cristina

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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© International Headache Society 2019

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