RECRUITING

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

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Conditions

Migraineacute

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1

Quick Facts

Study Start:2020-06-15
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04396236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * History of migraine attacks for more than 6 months
  3. * Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
  4. * Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
  5. * Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
  6. * Participant must be able to swallow a tablet
  7. * For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
  8. * Participants must weigh at least 15 kilograms (kg)
  1. * Participants must not be pregnant or nursing
  2. * Participants must not have any acute, serious, or unstable medical condition
  3. * Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator

Contacts and Locations

Study Contact

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

Principal Investigator

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

Study Locations (Sites)

Central Research Associates
Birmingham, Alabama, 35205
United States
Rehabilitation & Neurological Services
Huntsville, Alabama, 35805
United States
Xenoscience
Phoenix, Arizona, 85004
United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Perseverance Research Center
Scottsdale, Arizona, 85254
United States
Center for Neurosciences
Tucson, Arizona, 85718
United States
Arkansas Children's
Little Rock, Arkansas, 72202
United States
Core Healthcare Group
Cerritos, California, 90703
United States
Pine Street Pediatrics
Exeter, California, 93221
United States
Sun Valley Research Center
Imperial, California, 92251
United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
United States
Sensa Health
Los Angeles, California, 90006
United States
Orange County Research Institute - Ontario
Ontario, California, 91762
United States
Medical Center for Clinical Research
San Diego, California, 92108-5899
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Wolfson Children's Hospital
Jacksonville, Florida, 32207
United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
United States
University of Miami Don Suffer Clinical Research Building
Miami, Florida, 33136
United States
Biotech Pharmaceutical Group
Miami, Florida, 33155
United States
New Horizon Research Center
Miami, Florida, 33165
United States
Ezy Medical Research
Miami, Florida, 33175
United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761
United States
Avanza Medical Research Center
Pensacola, Florida, 32503
United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
United States
USF Health
Tampa, Florida, 33612
United States
ForCare Clinical Research
Tampa, Florida, 33613
United States
Palm Beach Neurology
West Palm Beach, Florida, 33407
United States
Pediatric Neurology P.A.
Winter Park, Florida, 32789
United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
United States
Medical Research Partners
Ammon, Idaho, 83406
United States
St Luke's Meridian Medical Center
Meridian, Idaho, 83642
United States
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
United States
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
United States
St. Alexius Medical Center
Hoffman Estates, Illinois, 60169
United States
Chicago Headache Center and Research Institute - Naperville
Naperville, Illinois, 60563
United States
Qualmedica Research, LLC
Evansville, Indiana, 47715
United States
Fort Wayne Neurological Center - West
Fort Wayne, Indiana, 46804
United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
United States
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, 47630
United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265
United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67207
United States
Qualmedica Research, LLC
Bowling Green, Kentucky, 42101
United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
United States
Qualmedica Research, LLC
Owensboro, Kentucky, 42301
United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
United States
Velocity Clinical Research - New Orleans
New Orleans, Louisiana, 70119
United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
New England Regional headache Center, Inc
Worcester, Massachusetts, 01601
United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
United States
Michigan State University
East Lansing, Michigan, 48824
United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, 55337
United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Clinvest Research LLC
Springfield, Missouri, 65807
United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609
United States
Monroe Biomedical Research
Monroe, North Carolina, 28112
United States
Accellacare - Piedmont
Statesville, North Carolina, 28625
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Headache Center of Hope
Cincinnati, Ohio, 45236
United States
IPS Research Company
Oklahoma City, Oklahoma, 73106
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States
ARC Clinical Research at Wilson Parke
Austin, Texas, 78726
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
United States
Pain and Headache Centers of Texas
Houston, Texas, 77054
United States
ClinPoint Trials
Waxahachie, Texas, 75165
United States
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
United States
Medical Research Partners - Providence
Logan, Utah, 84341
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States
Core Clinical Research
Everett, Washington, 98201
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Seattle Clinical Research Center
Seattle, Washington, 98105
United States
MultiCare Health System
Tacoma, Washington, 98405
United States
Marshall Medical Center
Huntington, West Virginia, 25701
United States
Frontier Clinical Research
Kingwood, West Virginia, 26537
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-15
Study Completion Date2025-01

Study Record Updates

Study Start Date2020-06-15
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • acute

Additional Relevant MeSH Terms

  • Migraine