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 sites1,338 target enrollmentFebruary 21, 2024

Overview

No summary available.

Registry

who.int

Start Date

February 21, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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