Ishaq Abu-Arafeh1, Andrew D Hershey2, Hans-Christoph Diener3, Cristina Tassorelli4,5. 1. 1 Paediatric Neurosciences Unit, Royal Hospital for Children, Glasgow, UK. 2. 2 Department of Pediatrics and Neurology, Cincinnati Children's Hospital, University of Cincinnati, College of Medicine, Cincinnati, OH, USA. 3. 3 Department of Neurology, University Hospital Essen, Essen, Germany. 4. 4 Headache Science Center, IRCCS C. Mondino Foundation, Pavia, Italy. 5. 5 Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
Abstract
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.
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.
Entities:
Keywords:
Migraine; acute treatment; adolescent; child; chronic migraine; migraine with aura; migraine without aura; preventive treatment
Authors: Matthew J Khayata; Samantha Farley; J Kelly Davis; Christoph P Hornik; Bryce B Reeve; Aruna Rikhi; Amy A Gelfand; Christina L Szperka; Shirley Kessel; Tara Pezzuto; Alex Hammett; Monica E Lemmon Journal: Headache Date: 2022-05-06 Impact factor: 5.311
Authors: Hadas Nahman-Averbuch; Victor J Schneider; Leigh Ann Chamberlin; Ashley M Kroon Van Diest; James L Peugh; Gregory R Lee; Rupa Radhakrishnan; Andrew D Hershey; Scott W Powers; Robert C Coghill; Christopher D King Journal: Pain Date: 2021-02-01 Impact factor: 7.926