A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
NCT ID: NCT05127486
Last Updated: 2024-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
580 participants
INTERVENTIONAL
2021-12-06
2023-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Galcanezumab
Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months.
1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.
Galcanezumab
Administered SC.
Placebo
Administered orally.
Rimegepant
Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months.
2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.
Rimegepant
Administered orally.
Placebo
Administered SC.
Interventions
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Galcanezumab
Administered SC.
Rimegepant
Administered orally.
Placebo
Administered orally.
Placebo
Administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have acute cardiovascular events and/or serious cardiovascular risk, or have had myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty.
* Evidence of significant psychiatric disease by medical history, such as schizophrenia, personality disorders, or other serious mood or anxiety disorders.
* Women who are pregnant or nursing
* Current use or prior exposure to any calcitonin gene related peptide (CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Gilbert Neurology
Gilbert, Arizona, United States
Foothills Research Center / CCT Research
Phoenix, Arizona, United States
Alliance for Multispecialty Research, LLC Tempe
Tempe, Arizona, United States
Velocity Clinical Research, Banning
Banning, California, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, United States
Wr- Pri, Llc
Encino, California, United States
Velocity Clinical Research, San Diego
La Mesa, California, United States
California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)
Los Angeles, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, United States
Anderson Clinical Research
Redlands, California, United States
Center for Clinical Trials of Sacramento
Sacramento, California, United States
Velocity Clinical Research, Huntington Park
Santa Ana, California, United States
Encompass Clinical Research
Spring Valley, California, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Innovative Research of West Florida
Clearwater, Florida, United States
AMR Miami
Coral Gables, Florida, United States
Accel Research Sites- Clinical Research Unit
DeLand, Florida, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
Accel Research Sites-LKD CRU
Lakeland, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
University of South Florida
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
DelRicht Research
Atlanta, Georgia, United States
Better Health Clinical Research
Newnan, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Chicago Headache Center
Chicago, Illinois, United States
American Health Network of Indiana, LLC - Avon
Avon, Indiana, United States
Deaconess Clinic
Evansville, Indiana, United States
Alliance for Multispecialty Research, LLC El Dorado
El Dorado, Kansas, United States
Alliance for Multispecialty Research, LLC Lexington
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
DelRicht Research
Covington, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
DelRicht Research
Prairieville, Louisiana, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
MedPharmics, LLC
Gulfport, Mississippi, United States
Healthcare Research Network - St. Louis
Hazelwood, Missouri, United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Dent Neurosciences Research Center (Research Facility)
Amherst, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
NeuroScience Research Center, LLC
Canton, Ohio, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
Tekton Research
Edmond, Oklahoma, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
DelRicht Research
Tulsa, Oklahoma, United States
Tekton Research
Yukon, Oklahoma, United States
Velocity Clinical Research, Grants Pass (Research Facility)
Grants Pass, Oregon, United States
Velocity Clinical Research - Medford
Medford, Oregon, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
Premier Neurology Research, P.C.
Greer, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Tekton Research (Research Facility)
Austin, Texas, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
ACRC Trials
Austin, Texas, United States
ACRC Trials
Carrollton, Texas, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, United States
Ventavia Research Group
Fort Worth, Texas, United States
Accurate Clinical Management - Houston
Houston, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Humble, Texas, United States
Ventavia Research Group - Keller
Keller, Texas, United States
ACRC Trials
Plano, Texas, United States
Alpine Research Organization
Clinton, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
Alliance for Multispecialty Research, LLC - AMR Norfolk
Norfolk, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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References
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Schwedt TJ, Myers Oakes TM, Martinez JM, Vargas BB, Pandey H, Pearlman EM, Richardson DR, Varnado OJ, Cobas Meyer M, Goadsby PJ. Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial. Neurol Ther. 2024 Feb;13(1):85-105. doi: 10.1007/s40120-023-00562-w. Epub 2023 Nov 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine (CHALLENGE-MIG)
Other Identifiers
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I5Q-MC-CGBD
Identifier Type: OTHER
Identifier Source: secondary_id
18256
Identifier Type: -
Identifier Source: org_study_id
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