A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
Launched by ELI LILLY AND COMPANY · Feb 8, 2018
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a medication called galcanezumab to see how well it works in preventing episodic migraines in children and teenagers aged 6 to 17 years. The main goal is to find out if galcanezumab can reduce the number of days they experience migraine headaches compared to a placebo, which is a treatment that has no active ingredients. The study will take place over three months, and participants will not know whether they are receiving the actual medication or the placebo during this time.
To join the study, participants need to have a diagnosis of migraine for at least six months and can't have certain health conditions or be on specific medications that could interfere with the trial. While the study is currently recruiting participants, it's important for families to understand that those with a history of certain headaches, significant injuries, or previous use of similar treatments may not be eligible. If chosen to participate, families can expect regular check-ins and assessments to monitor how well the treatment is working and to ensure participants' safety throughout the study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 \[2018\]), with a history of migraine headaches of at least 6 months prior to screening.
- Exclusion Criteria:
- • Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline.
- • Known hypersensitivity to monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
- • Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
- • History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
- • History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
- • Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Miami, Florida, United States
Phoenix, Arizona, United States
Cincinnati, Ohio, United States
Aurora, Colorado, United States
Seattle, Washington, United States
Cincinnati, Ohio, United States
Barcelona, , Spain
Pittsburgh, Pennsylvania, United States
Amherst, New York, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Dallas, Texas, United States
Dallas, Texas, United States
Barcelona, , Spain
Valencia, , Spain
Toms River, New Jersey, United States
Sevilla, , Spain
Valladolid, , Spain
New Delhi, Delhi, India
Shinjuku Ku, Tokyo, Japan
Boise, Idaho, United States
Barcelona, , Spain
Valencia, , Spain
Hoffman Estates, Illinois, United States
Bellevue, Washington, United States
Portland, Oregon, United States
Tucson, Arizona, United States
Pittsburgh, Pennsylvania, United States
Roma, , Italy
Phoenix, Arizona, United States
Tampa, Florida, United States
Phoenix, Arizona, United States
Bellevue, Washington, United States
Atlanta, Georgia, United States
Barcelona, , Spain
Boston, Massachusetts, United States
Pompano Beach, Florida, United States
Mangalore, Karnataka, India
West Palm Beach, Florida, United States
Nagpur, Maharashtra, India
New Delhi, Delhi, India
Kansas City, Kansas, United States
Milano, , Italy
Hoffman Estates, Illinois, United States
Roma, , Italy
Kolkata, West Bengal, India
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Savannah, Georgia, United States
Blackfoot, Idaho, United States
Pune, Maharashtra, India
Orlando, Florida, United States
Great Neck, New York, United States
Orlando, Florida, United States
Seattle, Washington, United States
Long Beach, California, United States
Ocoee, Florida, United States
Ontario, California, United States
Jacksonville, Florida, United States
Meridian, Idaho, United States
Pensacola, Florida, United States
Guadalajara, Jalisco, Mexico
Tampa, Florida, United States
East Greenwich, Rhode Island, United States
Jupiter, Florida, United States
Ahmedabad, Gujarat, India
Barcelona, Barcelona [Barcelona], Spain
San Diego, California, United States
San Diego, California, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Long Beach, California, United States
Ontario, California, United States
Miami, Florida, United States
Lexington, Kentucky, United States
Lawrence, Massachusetts, United States
Waltham, Massachusetts, United States
Burnsville, Minnesota, United States
Kansas City, Missouri, United States
Amherst, New York, United States
Lake Success, New York, United States
East Greenwich, Rhode Island, United States
Houston, Texas, United States
Gandrup, North Jutland, Denmark
Herlev, , Denmark
Essen, Nordrhein Westfalen, Germany
New Delhi, Delhi, India
Nagpur, Maharashtra, India
Nagpur, , India
Napoli, Naples, Italy
Roma, , 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
Morelia, Michoacan, Mexico
Aguascalientes, , Mexico
Chihuahua, , Mexico
Zwolle, Overijssel, Netherlands
Caguas, , Puerto Rico
Valladolid, , Spain
Methuen, Massachusetts, United States
Greenville, South Carolina, United States
Huntsville, Alabama, United States
North Palm Beach, Florida, United States
Nagpur, Maharashtra, India
Miami, Florida, United States
Ponce, , Puerto Rico
Jacksonville, Florida, United States
Meridian, Idaho, United States
Overland Park, Kansas, United States
Burnsville, Minnesota, United States
Copenhagen, Hovedstaden, Denmark
Valencia, Valenciana, Comunitat, Spain
Houston, Texas, United States
Aalborg, Nordjylland, Denmark
Ammon, Idaho, United States
Nagpur, Maharashtra, India
Milano, Lombardia, Italy
Barcelona, Barcelona [Barcelona], Spain
Kobe, Hyogo, Japan
Raleigh, North Carolina, United States
Napoli, Campania, Italy
Madrid, , Spain
Nagpur, Maharashtra, India
Caguas, , Puerto Rico
New Hyde Park, New York, United States
Essen, Nordrhein Westfalen, Germany
Roma, Lazio, Italy
Guadalajara, Jalisco, Mexico
San Juan, , Puerto Rico
Pittsburgh, Pennsylvania, United States
Tucson, Arizona, United States
Atlanta, Georgia, United States
Mexico City, , Mexico
Essen, Nordrhein Westfalen, Germany
Essen, Nordrhein Westfalen, Germany
Aguascalientes, , Mexico
Hoffman Estates, Illinois, United States
Raleigh, North Carolina, United States
Milano, Lombardia, Italy
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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