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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

Key facts

Study ID

NCT04396236

Run by

Eli Lilly and Company

People needed

851

Starts

2020-06-15

Expected to finish

2025-11-12

Last updated by the study team

2026-03-10

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 with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria:
• History of migraine attacks for more than 6 months
• Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
• Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
• Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
• Participant must be able to swallow a tablet
• For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
• Participants must weigh at least 15 kilograms (kg)

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

Where it is running

• Rehabilitation & Neurological Services — Huntsville, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Perseverance Research Center — Scottsdale, Arizona, United States
• Center for Neurosciences — Tucson, Arizona, United States
• Arkansas Children's — Little Rock, Arkansas, United States
• Core Healthcare Group — Cerritos, California, United States
• Pine Street Pediatrics — Exeter, California, United States
• Sun Valley Research Center — Imperial, California, United States
• Miller Children's & Women's Hospital Long Beach — Long Beach, California, United States
• Sensa Health — Los Angeles, California, United States
• Orange County Research Institute - Ontario — Ontario, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Wolfson Children's Hospital — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
• Biotech Pharmaceutical Group — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Ezy Medical Research — Miami Lakes, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Avanza Medical Research Center — Pensacola, Florida, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• USF Health — Tampa, Florida, United States
• Central Research Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.