A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

TITLE:
Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
MEDICAL CONDITION: Migraine
AGE: 6-17yrs
SEX/GENDER: All

OVERVIEW

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

STUDY DETAILS

Inclusion Criteria:

  • 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:
  • 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
  • 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)

Exclusion Criteria:

  • 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