A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Migraine

Treatments: Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04396574

16930

2019-004379-38 (EudraCT Number)

H8H-MC-LAHW (Other Identifier)

Details and patient eligibility

About

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,000 participants in 2 patient groups

Lasmiditan Dose 1

Experimental group

Description:

Lasmiditan administered orally.

Treatment:

Drug: Lasmiditan

Lasmiditan Dose 2

Experimental group

Description:

Lasmiditan administered orally.

Treatment:

Drug: Lasmiditan