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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 6 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lasmiditan High Dose 		Lasmiditan administered orally with matching placebo to maintain the blind.
  • Drug: Lasmiditan
    Administered orally
    Other names:
    • LY573144
  • Drug: Placebo
    Administered orally
Experimental
Lasmiditan Mid Dose 		Lasmiditan administered orally with matching placebo to maintain the blind.
  • Drug: Lasmiditan
    Administered orally
    Other names:
    • LY573144
  • Drug: Placebo
    Administered orally
Experimental
Lasmiditan Low Dose 		Lasmiditan administered orally with matching placebo to maintain the blind.
  • Drug: Lasmiditan
    Administered orally
    Other names:
    • LY573144
  • Drug: Placebo
    Administered orally
Placebo Comparator
Placebo 		Placebo administered orally.
  • Drug: Placebo
    Administered orally

Recruiting Locations

Rehabilitation & Neurological Services
Huntsville, Alabama 35805
Contact:
256-885-9708

Xenoscience
Phoenix, Arizona 85004
Contact:
602-274-9500

Phoenix Children's Hospital
Phoenix, Arizona 85016

Perseverance Research Center
Scottsdale, Arizona 85254
Contact:
480-471-6132

Center for Neurosciences
Tucson, Arizona 85718
Contact:
520-320-2157

Miller Children's & Women's Hospital Long Beach
Long Beach, California 90806
Contact:
562-490-3580

Sensa Health
Los Angeles, California 90006

Orange County Research Institute - Ontario
Ontario, California 91762
Contact:
909-395-9788

Medical Center for Clinical Research
San Diego, California 92108-5899
Contact:
619-521-2830

Yale University School of Medicine
New Haven, Connecticut 06510

Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut 06905
Contact:
203-914-1903

University of Miami Don Suffer Clinical Research Building
Miami, Florida 33136
Contact:
305-243-8555

Biotech Pharmaceutical Group
Miami, Florida 33155

New Horizon Research Center
Miami, Florida 33165
Contact:
305-226-3933

Ezy Medical Research
Miami, Florida 33175
Contact:
305-793-1853

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652
Contact:
727-781-3655

Sensible Healthcare, LLC
Ocoee, Florida 34761
Contact:
407-654-2724

Avanza Medical Research Center
Pensacola, Florida 32503
Contact:
850-972-9322

USF Health
Tampa, Florida 33612
Contact:
813-396-2736

Pediatric Neurology P.A.
Winter Park, Florida 32789

Meridian Clinical Research, LLC
Savannah, Georgia 31406
Contact:
912-790-4837

Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia 30291
Contact:
470-317-3604

Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
Contact:
808-564-6141

Medical Research Partners
Ammon, Idaho 83406
Contact:
208-681-9070

St Luke's Meridian Medical Center
Meridian, Idaho 83642
Contact:
208-706-9085

Chicago Headache Center and Research Institute
Chicago, Illinois 60657

St. Alexius Medical Center
Hoffman Estates, Illinois 60169

Chicago Headache Center and Research Institute - Naperville
Naperville, Illinois 60563

Qualmedica Research, LLC
Evansville, Indiana 47715
Contact:
812-205-2475

Fort Wayne Neurological Center - West
Fort Wayne, Indiana 46804
Contact:
260-436-2416x2179

Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana 46256

Deaconess Clinic - Gateway Health Center
Newburgh, Indiana 47630
Contact:
812-492-5011

Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa 50265
Contact:
515-223-2300

Qualmedica Research, LLC
Bowling Green, Kentucky 42101
Contact:
270-685-4589

University of Kentucky Chandler Medical Center
Lexington, Kentucky 40536

Qualmedica Research, LLC
Owensboro, Kentucky 42301
Contact:
270-685-4589

Children's Hospital New Orleans
New Orleans, Louisiana 70118

Velocity Clinical Research - New Orleans
New Orleans, Louisiana 70119
Contact:
985-273-0855

Great Lakes Research Group, Inc.
Bay City, Michigan 48706
Contact:
989-895-9100

Michigan State University
East Lansing, Michigan 48824
Contact:
517-884-8922

Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota 55337

Monroe Biomedical Research
Monroe, North Carolina 28112
Contact:
704-283-7359

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

Headache Center of Hope
Cincinnati, Ohio 45236
Contact:
513-898-9400

IPS Research Company
Oklahoma City, Oklahoma 73106
Contact:
405-235-8188

Oregon Health and Science University
Portland, Oregon 97239

Frontier Clinical Research, LLC
Scottdale, Pennsylvania 15683
Contact:
724-220-5281

Frontier Clinical Research, LLC
Smithfield, Pennsylvania 15478
Contact:
724-569-8036

Velocity Clinical Research, Providence
East Greenwich, Rhode Island 02818

Tribe Clinical Research, LLC
Greenville, South Carolina 29607
Contact:
864-334-0141

ClinPoint Trials
Waxahachie, Texas 75165
Contact:
972-937-1640

Medical Research Partners - Logan
Logan, Utah 84341
Contact:
208-681-9070

Seattle Children's Hospital
Seattle, Washington 98105
Contact:
206-987-2078

MultiCare Health System
Tacoma, Washington 98405

Marshall Medical Center
Huntington, West Virginia 25701

Frontier Clinical Research
Kingwood, West Virginia 26537
Contact:
304-441-2006

Dr. Samuel Sanchez PSC
Caguas, Puerto Rico 00727
Contact:
787-746-3136

Puerto Rico Health Institute
Dorado, Puerto Rico 00646
Contact:
7877961049

Ponce Medical School Foundation Inc.
Ponce, Puerto Rico 00716
Contact:
787-840-2505

Wellness clinical Research Vega Baja
Vega Baja, Puerto Rico 694
Contact:
787-654-9444

More Details

NCT ID
NCT04396236
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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