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

Completed · Phase 1

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT03988088

Run by

Eli Lilly and Company

People needed

18

Starts

2019-07-22

Expected to finish

2020-02-24

Last updated by the study team

2020-09-01

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Perserverance Research Center — Scottsdale, Arizona, United States
• Newport Beach Clinical Research Associates, Inc. — Newport Beach, California, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• Meridien Research — Bradenton, Florida, United States
• Meridien Research — Maitland, Florida, United States
• Qps-Mra, Llc — South Miami, Florida, United States
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Kurume Clinical Pharmacology Clinic — Kurume, Fukuoka, Japan
• Clinical Research Hospital, Tokyo — Shinjuku-Ku, Tokyo, Japan
• San Jorge Children and Women's Hospital- Shipping Location — San Juan, PR, Puerto Rico

Full record on ClinicalTrials.gov

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