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

Lilly

Status and phase: Terminated; Phase 3

Conditions: Migraine

Treatments: Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04396574

16930

2019-004379-38 (EudraCT Number)

2023-506724-85-00 (EU Trial (CTIS) 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: 558 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)

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558 participants in 2 patient groups

25/50/100 mg Lasmiditan

Experimental group

Description:

* Participants received lasmiditan \[50 milligram (mg) for body weight less than or equal to 40 kilogram (≤ 40 kg) or 100 mg for body weight greater than (\>)40 kg\] administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month. * One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.

Treatment:

Drug: Lasmiditan

50/100/200 mg Lasmiditan

Experimental group

Description:

* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month. * One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.

Treatment:

Drug: Lasmiditan