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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 Sex
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 4068590, Alabama 4829764 35805
Contact:
256-885-9708

Perseverance Research Center
Scottsdale 5313457, Arizona 5551752 85254
Contact:
480-471-6132

Center for Neurosciences
Tucson 5318313, Arizona 5551752 85718
Contact:
520-320-2157

Sensa Health
Los Angeles 5368361, California 5332921 90006

Orange County Research Institute - Ontario
Ontario 5379439, California 5332921 91762
Contact:
909-395-9788

Yale University School of Medicine
New Haven 4839366, Connecticut 4831725 06510

Biotech Pharmaceutical Group
Miami 4164138, Florida 4155751 33155

New Horizon Research Center
Miami 4164138, Florida 4155751 33165
Contact:
305-226-3933

Ezy Medical Research
Miami 4164138, Florida 4155751 33175
Contact:
305-793-1853

Suncoast Clinical Research, Inc.
New Port Richey 4165869, Florida 4155751 34652
Contact:
727-781-3655

Avanza Medical Research Center
Pensacola 4168228, Florida 4155751 32503
Contact:
850-477-7900

USF Health
Tampa 4174757, Florida 4155751 33612
Contact:
813-396-2736

Pediatric Neurology P.A.
Winter Park 4178560, Florida 4155751 32789

Rophe Adult and Pediatric Medicine/SKYCRNG
Union City 4227777, Georgia 4197000 30291
Contact:
470-317-3604

Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797 96817
Contact:
808-564-6141

Medical Research Partners
Ammon 5583997, Idaho 5596512 83406
Contact:
208-681-9070

Chicago Headache Center and Research Institute
Chicago 4887398, Illinois 4896861 60657

Chicago Headache Center and Research Institute - Naperville
Naperville 4903279, Illinois 4896861 60563

Qualmedica Research, LLC
Evansville 4257227, Indiana 4921868 47715
Contact:
812-205-2475

Fort Wayne Neurological Center - West
Fort Wayne 4920423, Indiana 4921868 46804
Contact:
260-436-2416x2179

Josephson Wallack Munshower Neurology, PC
Indianapolis 4259418, Indiana 4921868 46256

Deaconess Clinic - Gateway Health Center
Newburgh 4262171, Indiana 4921868 47630
Contact:
812-492-5011

Integrated Clinical Trial Services, Inc.
West Des Moines 4881346, Iowa 4862182 50265
Contact:
515-223-2300

Qualmedica Research, LLC
Bowling Green 4285268, Kentucky 6254925 42101
Contact:
270-685-4589

University of Kentucky Chandler Medical Center
Lexington 4297983, Kentucky 6254925 40536

Qualmedica Research, LLC
Owensboro 4303436, Kentucky 6254925 42301
Contact:
270-685-4589

Children's Hospital New Orleans
New Orleans 4335045, Louisiana 4331987 70118

Velocity Clinical Research - New Orleans
New Orleans 4335045, Louisiana 4331987 70119
Contact:
985-273-0855

Michigan State University
East Lansing 4991640, Michigan 5001836 48824
Contact:
517-884-8922

Minneapolis Clinic of Neurology - Burnsville Office
Burnsville 5019767, Minnesota 5037779 55337

SKY Integrative Medical Center/SKYCRNG
Ridgeland 4443296, Mississippi 4436296 39157
Contact:
601-617-7717

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112
Contact:
704-283-7359

Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229

Headache Center of Hope
Cincinnati 4508722, Ohio 5165418 45236
Contact:
513-898-9400

Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239

Frontier Clinical Research, LLC
Scottdale 5211279, Pennsylvania 6254927 15683
Contact:
724-220-5281

Frontier Clinical Research, LLC
Smithfield 4561301, Pennsylvania 6254927 15478
Contact:
724-569-8036

Velocity Clinical Research, Providence
East Greenwich 5221875, Rhode Island 5224323 02818

Tribe Clinical Research, LLC
Greenville 4580543, South Carolina 4597040 29607
Contact:
864-334-0141

ClinPoint Trials
Waxahachie 4740328, Texas 4736286 75165
Contact:
972-937-1640

Medical Research Partners - Logan
Logan 5777544, Utah 5549030 84341
Contact:
208-681-9070

Seattle Children's Hospital
Seattle 5809844, Washington 5815135 98105
Contact:
206-987-2078

Marshall Medical Center
Huntington 4809537, West Virginia 4826850 25701

Frontier Clinical Research
Kingwood 4811007, West Virginia 4826850 26537
Contact:
304-441-2006

Dr. Samuel Sanchez PSC
Caguas 4563008, Puerto Rico 00727
Contact:
787-746-3136

Puerto Rico Health Institute
Dorado 4564133, Puerto Rico 00646
Contact:
7877961049

Ponce Medical School Foundation Inc.
Ponce 4566880, Puerto Rico 00716
Contact:
787-840-2505

Wellness clinical Research Vega Baja
Vega Baja 4568533, 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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