Protocol H8H-MC-LAHV(a)Pediatric Options for Migraine Relief: A Randomized,Double-Blind, Placebo-Controlled Study of Lasmiditan forAcute Treatment of Migraine: PIONEER-PEDS1

Protocol H8H-MC-LAHV, titled Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine (PIONEER-PEDS1), is a late-phase international clinical study sponsored by Eli Lilly and Company to evaluate lasmiditan for the acute treatment of migraine in children and adolescents. Migraines affect an estimated 7.7% of people under 20 worldwide and can cause intense pain and symptoms such as vomiting and sensitivity to light, with substantial negative impact on quality of life, school attendance, and everyday functioning. Current paediatric treatment options are limited; some patients respond poorly or experience unacceptable side effects, creating a clear need for additional safe and effective acute therapies. Lasmiditan is a novel drug with evidence suggesting it can block migraine-related pain pathways and produce pain freedom two hours after dosing in adults; it has recently been approved for acute migraine treatment in adults in the United States. PIONEER-PEDS1 aims to investigate whether weight-based doses of lasmiditan corresponding to 50 mg, 100 mg, and 200 mg—are effective and safe for treating a single migraine attack in paediatric patients aged 6 to 18 years who meet International Classification of Headache Disorders criteria and can swallow a tablet.

By enrolling a large international cohort and including a UK contribution, the study seeks to generate generalizable evidence across varied populations. As a late-phase study sponsored by Eli Lilly and Company and coordinated with local research governance and ethics oversight, PIONEER-PEDS1 represents a significant effort to expand therapeutic options for paediatric migraine, with the potential to inform regulatory decisions and clinical practice if lasmiditan demonstrates favorable efficacy and safety profiles in this younger population. The trial's findings will be important to clinicians, patients, and families seeking effective acute migraine relief for children and adolescents.