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

Phase 1

Completed

• Conditions: Migraine
• Interventions: Drug: Lasmiditan

• Registration Number: NCT03988088
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-17
• Study Start: 2019-07-22
• Primary Completion: 2020-01-19
• Study Completion: 2020-02-24
• Status Verified: 2020-05-01
• Results First Submitted: 2020-08-14
• Results First Submitted QC: 2020-08-14
• Last Update Submitted: 2020-08-14
• Results First Posted: 2020-09-01
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lasmiditan	Lasmiditan	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.

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan	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.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan	0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.

Trial Locations

Locations (10)

Clinical Research Hospital, Tokyo; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

Newport Beach Clinical Research Associates, Inc.; 🇺🇸 Newport Beach, California, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Kurume Clinical Pharmacology Clinic; 🇯🇵 Kurume, Fukuoka, Japan

Perserverance Research Center; 🇺🇸 Scottsdale, Arizona, United States

Meridien Research; 🇺🇸 Maitland, Florida, United States

New England Institute for Clinical Research; 🇺🇸 Stamford, Connecticut, United States

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States

Premiere Research Institute at Palm Beach Neurology; 🇺🇸 West Palm Beach, Florida, United States

San Jorge Children and Women's Hospital- Shipping Location; 🇵🇷 San Juan, Puerto Rico