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Search / Trial NCT04396236

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

Launched by ELI LILLY AND COMPANY · May 18, 2020

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Acute

ClinConnect Summary

This clinical trial is studying a medication called lasmiditan to see if it is safe and effective for children aged 6 to 17 who suffer from migraines. The researchers want to find out if this treatment can help manage migraine symptoms in young patients who have experienced at least two to eight moderate-to-severe migraine attacks each month for the past two months. To be eligible for the study, children must have a history of migraine for more than six months, be able to swallow a tablet, and weigh at least 15 kilograms (about 33 pounds).

The study will last up to 20 weeks and may involve around four visits to the research site. Participants will need to have stable migraine preventive medication for at least three months before joining the trial. It's important to note that children who are pregnant, nursing, or have serious health issues cannot participate. This study aims to improve treatment options for young people suffering from migraines, and everyone involved will be closely monitored to ensure their safety throughout the trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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)
  • 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

About Eli Lilly And Company

Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.

Locations

East Lansing, Michigan, United States

Kansas City, Missouri, United States

New Orleans, Louisiana, United States

Madrid, , Spain

Corpus Christi, Texas, United States

Miami, Florida, United States

Phoenix, Arizona, United States

Cincinnati, Ohio, United States

Washington, District Of Columbia, United States

Rochester, New York, United States

Portland, Oregon, United States

Aurora, Colorado, United States

New Orleans, Louisiana, United States

Seattle, Washington, United States

Cincinnati, Ohio, United States

Gent, , Belgium

Fort Wayne, Indiana, United States

New Port Richey, Florida, United States

Lexington, Kentucky, United States

Tacoma, Washington, United States

West Palm Beach, Florida, United States

Bay City, Michigan, United States

Baltimore, Maryland, United States

Barcelona, , Spain

Barcelona, , Spain

Valencia, , Spain

Toms River, New Jersey, United States

Nishinomiya, Hyogo, Japan

Paris, , France

Paris, , France

New Port Richey, Florida, United States

Freiburg, , Germany

Sevilla, , Spain

Valladolid, , Spain

New Delhi, Delhi, India

West Des Moines, Iowa, United States

Shinjuku Ku, Tokyo, Japan

Madrid, , Spain

Barcelona, , Spain

New Delhi, , India

Lille, , France

Sabadell, Barcelona, Spain

Barcelona, , Spain

Hiroshima, , Japan

Chapel Hill, North Carolina, United States

Hoffman Estates, Illinois, United States

Nijmegen, Gelderland, Netherlands

Stockport, , United Kingdom

Bellevue, Washington, United States

Pune, Maharashtra, India

Brussels, , Belgium

Imperial, California, United States

Tucson, Arizona, United States

Roma, , Italy

Jacksonville, Florida, United States

Tampa, Florida, United States

Madrid, , Spain

Jette, Brussels, Belgium

Newburgh, Indiana, United States

Phoenix, Arizona, United States

Bellevue, Washington, United States

Colorado Springs, Colorado, United States

Smithfield, Pennsylvania, United States

London, , United Kingdom

Pompano Beach, Florida, United States

Honolulu, Hawaii, United States

Mangalore, Karnataka, India

West Palm Beach, Florida, United States

Nagpur, Maharashtra, India

New Delhi, Delhi, India

Gurgaon, Haryana, India

Stamford, Connecticut, United States

Indianapolis, Indiana, United States

Milano, , Italy

Hoffman Estates, Illinois, United States

Florence, , Italy

Roma, , Italy

Savannah, Georgia, United States

Kolkata, West Bengal, India

Ponce, , Puerto Rico

Constanta, , Romania

Gent, Oost Vlaanderen, Belgium

Savannah, Georgia, United States

Chandigarh, , India

Seattle, Washington, United States

Great Yarmouth, Norfolk, United Kingdom

Bochum, Nordrhein Westfalen, Germany

Kyoto, , Japan

Maitland, Florida, United States

Oklahoma City, Oklahoma, United States

Long Beach, California, United States

Cerritos, California, United States

Austin, Texas, United States

Waxahachie, Texas, United States

Ocoee, Florida, United States

Scottdale, Pennsylvania, United States

Jacksonville, Florida, United States

Meridian, Idaho, United States

Nishinomiya, Hyogo, Japan

Pozuelo De Alarcon, Madrid, Spain

Pensacola, Florida, United States

Bochum, Nordrhein Westfalen, Germany

Toulouse Cedex 9, , France

Guadalajara, Jalisco, Mexico

Scottsdale, Arizona, United States

Tampa, Florida, United States

Amiens Cedex 1, , France

Marseille Cedex 5, , France

Strasbourg, , France

Birmingham, Alabama, United States

Creteil, , France

Everett, Washington, United States

Miami, Florida, United States

Monroe, North Carolina, United States

Clermont Ferrand, , France

Bad Homburg, Hesse, Germany

East Greenwich, Rhode Island, United States

Miami, Florida, United States

Ahmedabad, Gujarat, India

Thane, Maharashtra, India

Gent, East Flanders, Belgium

Evansville, Indiana, United States

Roma, , Italy

Sarnia, Ontario, Canada

Seattle, Washington, United States

Long Beach, California, United States

Ontario, California, United States

Miami, Florida, United States

Lexington, Kentucky, United States

Waltham, Massachusetts, United States

Burnsville, Minnesota, United States

Kansas City, Missouri, United States

Houston, Texas, United States

Essen, Nordrhein Westfalen, Germany

New Delhi, Delhi, India

Napoli, Naples, Italy

Kobe, Hyogo, Japan

Nishinomiya, Hyogo, Japan

Sendai, Miyagi, Japan

Kochi, , Japan

Kyoto, , Japan

Osaka, , Japan

Tokyo, , Japan

Ciudad De Mexico, Federal District, Mexico

Guadalajara, Ja, Mexico

Aguascalientes, , Mexico

Chihuahua, , Mexico

Zwolle, Overijssel, Netherlands

Caguas, , Puerto Rico

Tampa, Florida, United States

Kagoshima, , Japan

Fargo, North Dakota, United States

Owensboro, Kentucky, United States

Bucuresti, , Romania

Stamford, Connecticut, United States

Monterrey, Nuevo León, Mexico

Saint Petersburg, Sankt Peterburg, Russian Federation

Bloomsbury, London, United Kingdom

Saint Petersburg, , Russian Federation

Newburgh, Indiana, United States

Methuen, Massachusetts, United States

Miami, Florida, United States

New Haven, Connecticut, United States

Austin, Texas, United States

Evansville, Indiana, United States

Huntington, West Virginia, United States

Vega Baja, , Puerto Rico

Esplugues De Llobregat, Barcelona [Barcelona], Spain

Nottingham, Nottinghamshire, United Kingdom

Scottsdale, Arizona, United States

Freiburg, Baden Württemberg, Germany

Austin, Texas, United States

Pensacola, Florida, United States

Little Rock, Arkansas, United States

Chicago, Illinois, United States

Bowling Green, Kentucky, United States

Springfield, Missouri, United States

Greenville, South Carolina, United States

Wichita, Kansas, United States

Dijon, , France

New Haven, Connecticut, United States

Huntsville, Alabama, United States

Cerritos, California, United States

Exeter, California, United States

Los Angeles, California, United States

San Diego, California, United States

North Palm Beach, Florida, United States

Tampa, Florida, United States

Winter Park, Florida, United States

Meridian, Idaho, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Lawrence, Massachusetts, United States

Worcester, Massachusetts, United States

Chapel Hill, North Carolina, United States

Statesville, North Carolina, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Greenville, South Carolina, United States

Norfolk, Virginia, United States

Tacoma, Washington, United States

Grace Hollogne, Liege, Belgium

Genk, Limburg, Belgium

Mont De Marsan Cedex, , France

Sindelfingen, Baden Württemberg, Germany

Bochum, North Rhine Westphalia, Germany

Mumbai, Maharashtra, India

Jaipur, Rajasthan, India

Jaipur, Rajasthan, India

Pavia, , Italy

Varese, , Italy

Kiryu, Gunma, Japan

Higashiyamaku, Kyoto, Japan

Minato Ku, Tokyo, Japan

Kai, Yamanashi, Japan

Cuernavaca, Morelos, Mexico

Bucharest, Sector 4, Romania

Brasov, , Romania

Iasi, , Romania

Moscow, Moskva, Russian Federation

Moscow, , Russian Federation

Moscow, , Russian Federation

Novosibirsk, , Russian Federation

Saint Petersburg, , Russian Federation

Valladolid, Castilla Y Leon, Spain

Esplugues De Llobregat, , Spain

London, Greater London, United Kingdom

London, Greater London, United Kingdom

Great Yarmouth, Norfolk, United Kingdom

Glasgow, , United Kingdom

Nottingham, , United Kingdom

Clermont Ferrand, Puy De Dôme, France

Esplugues De Llobregat, , Spain

London, London, City Of, United Kingdom

Kingwood, West Virginia, United States

Thane, Maharashtra, India

Miami, Florida, United States

London, , United Kingdom

Ponce, , Puerto Rico

Union City, Georgia, United States

Jacksonville, Florida, United States

Brussels, Bruxelles Capitale, Région De, Belgium

Meridian, Idaho, United States

Burnsville, Minnesota, United States

Mexico City, Distrito Federal, Mexico

Monterrey, Nuevo León, Mexico

Statesville, North Carolina, United States

Constanta, Constanța, Romania

Gurugram, Haryana, India

Saint Nicolas, Wallonne, Région, Belgium

Dorado, , Puerto Rico

Marseille, Bouches Du Rhône, France

Lille, Nord Pas De Calais, France

Valencia, Valenciana, Comunitat, Spain

Norman, Oklahoma, United States

Houston, Texas, United States

Clermont Ferrand, , France

Ammon, Idaho, United States

Austin, Texas, United States

Nagpur, Maharashtra, India

Ridgeland, Mississippi, United States

Milano, Lombardia, Italy

Meridian, Idaho, United States

Strasbourg, Bas Rhin, France

Bad Homburg, Hessen, Germany

Minato, Tokyo, Japan

Barcelona, Barcelona [Barcelona], Spain

Kobe, Hyogo, Japan

Metairie, Louisiana, United States

Layton, Utah, United States

Rochester, New York, United States

Firenze, Toscana, Italy

Mont De Marsan, Landes, France

Amiens, Somme, France

Miami, Florida, United States

Fort Wayne, Indiana, United States

Genk, Limburg, Belgium

Strasbourg, Bas Rhin, France

Toulouse, Haute Garonne, France

Créteil, Val De Marne, France

Napoli, Campania, Italy

Varese, , Italy

Kiryu, Gunma, Japan

Mexico City, Distrito Federal, Mexico

Guadalajara, Jalisco, Mexico

Aguascalientes, , Mexico

Vega Baja, , Puerto Rico

Bucharest, București, Romania

Bucharest, București, Romania

Iasi, Iași, Romania

Brașov, , Romania

Moscow, , Russian Federation

Sabadell, Barcelona [Barcelona], Spain

Madrid, , Spain

London, London, City Of, United Kingdom

Glagow, Scotland, United Kingdom

Jackson, Mississippi, United States

Créteil, Val De Marne, France

Nagpur, Maharashtra, India

Tucson, Arizona, United States

Essen, Nordrhein Westfalen, Germany

Fargo, North Dakota, India

Bari, Puglia, Italy

Constanta, , Romania

Kelowna, British Columbia, Canada

Kiryu, Gunma, Japan

Naperville, Illinois, United States

Bowling Green, Kentucky, United States

New Orleans, Louisiana, United States

Ridgeland, Mississippi, United States

Providence, Utah, United States

Cuernavaca, Morelos, Mexico

Worcester, Massachusetts, United States

Logan, Utah, United States

Logan, Utah, United States

Kagoshima, , Japan

Monterrey, , Mexico

Saint Nicolas, , Belgium

Bucharest, , Romania

Sabadell, , Spain

Patients applied

0 patients applied

Trial Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM

Study Director

Eli Lilly and Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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