H8H-MC-LAHV: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1 - H8H-MC-LAHV

Eli Lilly & Co.0 个研究点目标入组 1,338 人开始时间: 2024年2月21日最近更新: 2024年7月22日

研究概览

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•Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria: o History of migraine attacks for more than 6 months o Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit o Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours o Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator, Participant must be able to swallow a tablet, For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening, Participants must weigh at least 15 kilograms (kg)

•Participants must not be pregnant or nursing, Participants must not have any acute, serious, or unstable medical condition, Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator

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