Pediatric Options for Migraine Relief: A randomized, double-blind, placebo-controlled study of lasmiditan for acute treatment of migraine - PIONEER-PEDS1

Eli Lilly and Company0 个研究点目标入组 1,633 人开始时间: 2022年4月27日最近更新: 2022年5月2日

研究概览

暂无简介。

•[1] Patient is at least 6 and less than 18 years of age at Screening (Visit 1)
•[2] Patient must have a minimum body weight of 15 kg
•[3] Patient has 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:
•- History of migraine attacks for more than 6 months
•- Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to Screening Visit
•- Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
•- Patient has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1633
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•[1] Patient is pregnant or breastfeeding.
•[2] Patient has, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
•[3] Patient has known allergies to lasmiditan, related compounds, or any components of the formulation.

发起方