A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine

Lilly

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03988088

16932

H8H-MC-LAHX (Other Identifier)

Details and patient eligibility

About

The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine.

The study will last about 6 weeks, and includes 4 visits.

Enrollment: 18 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a history of migraine headaches for more than 6 months
• Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months
• Participants must weigh between 15 and 55 kilograms (kg)
• Participants must not have a migraine headache on the day of lasmiditan administration

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

• Participants must not be on a medicine that acts in the brain and spinal cord

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Lasmiditan

Experimental group

Description:

Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 milligrams (mg) Lasmiditan in Cohort 1 and higher body weight (\>40 to ≤55 kg) participants received single oral dose of 200 mg Lasmiditan in Cohort 2.

Treatment:

Drug: Lasmiditan