A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
Launched by ELI LILLY AND COMPANY · Nov 3, 2020
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called galcanezumab to see if it can help prevent chronic migraines in teenagers aged 12 to 17. Chronic migraines are defined as having headaches that occur 15 or more days each month for at least three months, with at least eight of those headaches showing typical migraine symptoms. The main goal of the study is to find out if galcanezumab is more effective than a placebo (a harmless pill with no active medicine) in reducing the number of migraine days each month over a three-month treatment period.
To participate, candidates must have a diagnosis of chronic migraine and meet certain criteria, such as not currently taking specific types of medications that could interfere with the study. Participants will be closely monitored during the trial, and their experiences will help researchers understand how well galcanezumab works and its safety for young people. This trial is currently recruiting participants, and it offers an opportunity for eligible teens to contribute to important research that could help improve treatment options for chronic migraines.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 \[2018\]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.
- 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, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
- • Known hypersensitivity 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
- • 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
Kansas City, Missouri, United States
New Brunswick, New Jersey, United States
Miami, Florida, United States
Phoenix, Arizona, United States
Cincinnati, Ohio, United States
Dallas, Texas, United States
Aurora, Colorado, United States
Seattle, Washington, United States
West Palm Beach, Florida, United States
Cincinnati, Ohio, United States
Barcelona, , Spain
Tampa, Florida, United States
Pittsburgh, Pennsylvania, United States
Amherst, New York, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Dallas, Texas, United States
Barcelona, , Spain
Barcelona, , Spain
Valencia, , Spain
Paris, , France
Paris, , France
Sevilla, , Spain
Flowood, Mississippi, United States
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
Phoenix, Arizona, United States
Tampa, Florida, United States
Sevilla, , Spain
Phoenix, Arizona, United States
Bellevue, Washington, United States
Atlanta, Georgia, United States
Pompano Beach, Florida, United States
Mangalore, Karnataka, India
Nagpur, Maharashtra, India
New Delhi, Delhi, India
Miami, Florida, United States
Gurgaon, Haryana, India
Milano, , Italy
Hoffman Estates, Illinois, United States
Roma, , Italy
Kolkata, West Bengal, India
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Blackfoot, Idaho, United States
Pune, Maharashtra, India
Charleston, South Carolina, United States
Great Neck, New York, United States
Seattle, Washington, United States
Mumbai, Maharashtra, India
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
Marseille Cedex 5, , France
Clermont Ferrand, , France
Jupiter, Florida, United States
Ahmedabad, Gujarat, India
San Diego, California, United States
Wichita, Kansas, United States
Miami Lakes, Florida, 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
Napoli, Naples, Italy
Roma, , Italy
Kobe, Hyogo, Japan
Nishinomiya, Hyogo, 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
Valladolid, , Spain
Miami Lakes, Florida, United States
Kagoshima, , Japan
Methuen, Massachusetts, United States
Huntsville, Alabama, United States
North Palm Beach, Florida, United States
Cincinnati, Ohio, United States
Mumbai, Maharashtra, India
Clermont Ferrand, Puy De Dôme, France
Amiens Cedex 1, , France
Gulf Breeze, Florida, United States
Roma, , Italy
Créteil, Paris, France
Lille, , France
Ahmedabad, Gujarat, India
Nagpur, Maharashtra, India
Kanpur, Uttar Pradesh, India
Miami, Florida, United States
Warwick, Rhode Island, United States
Ponce, , Puerto Rico
Jacksonville, Florida, United States
San Diego, California, United States
Warwick, Rhode Island, United States
Meridian, Idaho, United States
Overland Park, Kansas, United States
Burnsville, Minnesota, United States
Mexico City, Distrito Federal, Mexico
Copenhagen, Hovedstaden, Denmark
Gurugram, Haryana, India
Marseille, Bouches Du Rhône, France
Lille, Nord Pas De Calais, France
Valencia, Valenciana, Comunitat, Spain
Houston, Texas, United States
Aalborg, Nordjylland, Denmark
Bordeaux, , France
Ammon, Idaho, United States
Nagpur, Maharashtra, India
Milano, Lombardia, Italy
Marseille, , France
Barcelona, Barcelona [Barcelona], Spain
Kobe, Hyogo, Japan
Miami, Florida, United States
Raleigh, North Carolina, United States
Ridgeland, Mississippi, United States
Amiens, Somme, France
Napoli, Campania, Italy
Madrid, , Spain
Nagpur, Maharashtra, India
New Hyde Park, New York, United States
Bordeaux, Gironde, France
Essen, Nordrhein Westfalen, Germany
Roma, Lazio, Italy
Guadalajara, Jalisco, Mexico
San Juan, , Puerto Rico
Barcelona, Barcelona [Barcelona], Spain
Tucson, Arizona, United States
Ontario, , Canada
Denmark, , Denmark
Tamarac, Florida, United States
Tamarac, Florida, United States
Providence, Utah, United States
Clermont Ferrand, Puy De Dôme, France
Roma, , Italy
Nagpur, Maharashtra, India
Aguascalientes, , Mexico
Lewisville, Texas, United States
Miami, Florida, United States
Ciudad De Mexico, Federal District, Mexico
Logan, Utah, United States
Logan, Utah, United States
Miami, Florida, United States
Nashville, Tennessee, United States
Kagoshima, , Japan
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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