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.

临床试验是治疗头痛疾病的证据基础的关键组成部分。1991年，国际头痛学会临床试验常务委员会制定并出版了第一版偏头痛药物对照试验指南。近 30 年来，药物、器械和生物制品的进步以及新的试验设计促使多次更新，包括最近的慢性偏头痛预防性治疗对照试验指南（2018 年）、对照试验指南成人偏头痛发作的急性治疗（2019 年），以及儿童和青少年偏头痛预防性治疗对照试验指南(2019)。本更新纳入了新研究的结果，旨在优化成人发作性偏头痛预防性药物治疗对照试验的设计。器械临床试验指南将单独发布。