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Completed

NCT Number: NCT03988088

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kurume Clinical Pharmacology Clinic, Kurume, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lasmiditan

Drug

Administered orally.

Other names: LY573144

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose

    Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.

  2. PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan

    Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose

    PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2019
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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