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Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 3

Lasmiditan

Sponsor:

Eli Lilly and Company

Code:

NCT04396574

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Lasmiditan

Study Details

Brief summary:

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Conditions

Migraine

Study ID

NCT04396574

Start date

Jun 30, 2020

Status verified date

Oct, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
  • 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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lasmiditan Dose 1

Lasmiditan administered orally.

experimental: Lasmiditan Dose 2

Lasmiditan administered orally.

Interventions

Lasmiditan

Administered orally

Primary outcome measure

  • Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack [ Time Frame: Baseline through 12 Months ]
  • Percentage of Participants with Discontinuations Due to Adverse Events (AEs) [ Time Frame: Baseline through 12 Months ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Rehabilitation & Neurological Services

Recruiting

Huntsville, Alabama, United States, 35805

Contacts

Principal Investigator:

Belinda Savage-Edwards, MD

Perseverance Research Center

Recruiting

Scottsdale, Arizona, United States, 85254

Contacts

Principal Investigator:

allan block

Center for Neurosciences

Recruiting

Tucson, Arizona, United States, 85718

Contacts

Principal Investigator:

Dinesh Talwar

Orange County Research Institute - Ontario

Recruiting

Ontario, California, United States, 91762

Contacts

Principal Investigator:

Rosario Retino MD

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

Cristian Ionita

Biotech Pharmaceutical Group

Recruiting

Miami, Florida, United States, 33155

Principal Investigator:

Doris Diaz

New Horizon Research Center

Recruiting

Miami, Florida, United States, 33165

Contacts

Principal Investigator:

Lazaro Nunez

Ezy Medical Research

Recruiting

Miami Lakes, Florida, United States, 33015

Contacts

Principal Investigator:

Jorge Paoli-Bruno

Suncoast Clinical Research, Inc.

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

Principal Investigator:

Gary Goldstein

Avanza Medical Research Center

Recruiting

Pensacola, Florida, United States, 32503

Contacts

Principal Investigator:

Randall Reese

USF Health

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Melissa Moore

Pediatric Neurology P.A.

Recruiting

Winter Park, Florida, United States, 32789

Principal Investigator:

Ronald Davis

Rophe Adult and Pediatric Medicine/SKYCRNG

Recruiting

Union City, Georgia, United States, 30291

Contacts

Principal Investigator:

Yvonne Smith

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

Contacts

Principal Investigator:

Kore Liow

Medical Research Partners

Recruiting

Ammon, Idaho, United States, 83406

Contacts

Principal Investigator:

Joseph Moore

Chicago Headache Center and Research Institute

Recruiting

Chicago, Illinois, United States, 60657

Principal Investigator:

Bradley Torphy

Chicago Headache Center and Research Institute - Naperville

Recruiting

Naperville, Illinois, United States, 60563

Principal Investigator:

Bradley Torphy

Qualmedica Research, LLC

Recruiting

Evansville, Indiana, United States, 47715

Contacts

Principal Investigator:

David Brougher

Fort Wayne Neurological Center - West

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Principal Investigator:

Andrea Haller

Josephson Wallack Munshower Neurology, PC

Recruiting

Indianapolis, Indiana, United States, 46256

Principal Investigator:

Keith Ridel

Deaconess Clinic - Gateway Health Center

Recruiting

Newburgh, Indiana, United States, 47630

Contacts

Principal Investigator:

Renee Galen

Integrated Clinical Trial Services, Inc.

Recruiting

West Des Moines, Iowa, United States, 50265

Contacts

Principal Investigator:

James Coggi

Qualmedica Research, LLC

Recruiting

Bowling Green, Kentucky, United States, 42101

Contacts

Principal Investigator:

J Christopher Sartore

University of Kentucky Chandler Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

Sharoon Qaiser

Qualmedica Research, LLC

Recruiting

Owensboro, Kentucky, United States, 42301

Contacts

Principal Investigator:

J Christopher Sartore

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Principal Investigator:

Jessica Gautreaux

Michigan State University

Recruiting

East Lansing, Michigan, United States, 48824

Principal Investigator:

Suad Khalil

Minneapolis Clinic of Neurology - Burnsville Office

Recruiting

Burnsville, Minnesota, United States, 55337

Principal Investigator:

Rajiv Aggarwal

SKY Integrative Medical Center/SKYCRNG

Recruiting

Ridgeland, Mississippi, United States, 39157

Contacts

Principal Investigator:

Alisha Wilkes, NP

Clinvest Research LLC

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Principal Investigator:

Ralph Duda

Monroe Biomedical Research

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Principal Investigator:

Awawu Igbinadolor

Headache Center of Hope

Recruiting

Cincinnati, Ohio, United States, 45236

Contacts

Principal Investigator:

Hope O'Brien

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Kaitlin Greene

Frontier Clinical Research, LLC

Recruiting

Scottdale, Pennsylvania, United States, 15683

Contacts

Principal Investigator:

Tiffany Pluto

Frontier Clinical Research, LLC

Recruiting

Smithfield, Pennsylvania, United States, 15478

Contacts

Principal Investigator:

Marcy Goisse

Velocity Clinical Research, Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Contacts

Principal Investigator:

David Fried

Tribe Clinical Research, LLC

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Principal Investigator:

Scott Dobson

Pain and Headache Centers of Texas

Recruiting

Houston, Texas, United States, 77054

Principal Investigator:

Monika Ummat

ClinPoint Trials

Recruiting

Waxahachie, Texas, United States, 75165

Contacts

Principal Investigator:

Peggy Linguist

Medical Research Partners - Logan

Recruiting

Logan, Utah, United States, 84341

Contacts

Principal Investigator:

Joseph Moore

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Heidi Blume

Marshall Medical Center

Recruiting

Huntington, West Virginia, United States, 25701

Principal Investigator:

Jorge Lopez

Frontier Clinical Research

Recruiting

Kingwood, West Virginia, United States, 26537

Contacts

Principal Investigator:

Jeffry Pilney

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • acute
  • long-term
  • open label
  • safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2025-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.