A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
CHALLENGE-MIG
A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine
2 other identifiers
interventional
580
1 country
77
Brief Summary
The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2021
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
December 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2023
CompletedResults Posted
Study results publicly available
June 18, 2024
CompletedJune 28, 2024
June 1, 2024
1.5 years
November 3, 2021
May 22, 2024
June 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period.
A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 50% reduction in monthly migraine headache days from baseline (50% response rate) using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly migraine headache day.
Baseline, Month 1 through Month 3
Secondary Outcomes (9)
Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period.
Baseline, Month 1 through Month 3
Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period.
Baseline, Month 1 through Month 3
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period.
Baseline, Month 1 through Month 3
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1
Baseline, Month 1
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2
Baseline, Month 2
- +4 more secondary outcomes
Study Arms (2)
Galcanezumab
EXPERIMENTALParticipants 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.
Rimegepant
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
You may not qualify if:
- Have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, monoclonal antibodies or other therapeutic proteins
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Gilbert Neurology
Gilbert, Arizona, 85297, United States
Foothills Research Center / CCT Research
Phoenix, Arizona, 85044, United States
Alliance for Multispecialty Research, LLC Tempe
Tempe, Arizona, 85281, United States
Velocity Clinical Research, Banning
Banning, California, 99202, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911, United States
Wr- Pri, Llc
Encino, California, 91316, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)
Los Angeles, California, 90067, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Center for Clinical Trials of Sacramento
Sacramento, California, 95823, United States
Velocity Clinical Research, Huntington Park
Santa Ana, California, 92704, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, 06517, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
AMR Miami
Coral Gables, Florida, 33134, United States
Accel Research Sites- Clinical Research Unit
DeLand, Florida, 32720, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009, United States
Accel Research Sites-LKD CRU
Lakeland, Florida, 33803, United States
Visionary Investigators Network
Miami, Florida, 33176, United States
Visionary Investigators Network
Miami, Florida, 33180, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
University of South Florida
Tampa, Florida, 33612, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
DelRicht Research
Atlanta, Georgia, 30329, United States
Better Health Clinical Research
Newnan, Georgia, 30265, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Chicago Headache Center
Chicago, Illinois, 60657, United States
American Health Network of Indiana, LLC - Avon
Avon, Indiana, 46123, United States
Deaconess Clinic
Evansville, Indiana, 47713, United States
Alliance for Multispecialty Research, LLC El Dorado
El Dorado, Kansas, 67042, United States
Alliance for Multispecialty Research, LLC Lexington
Lexington, Kentucky, 40509, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
DelRicht Research
Covington, Louisiana, 70433, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
DelRicht Research
Prairieville, Louisiana, 70769, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
MedPharmics, LLC
Gulfport, Mississippi, 39503, United States
Healthcare Research Network - St. Louis
Hazelwood, Missouri, 63042, United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, 89119, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Dent Neurosciences Research Center (Research Facility)
Amherst, New York, 14226, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
NeuroScience Research Center, LLC
Canton, Ohio, 44718, United States
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, 45459, United States
Tekton Research
Edmond, Oklahoma, 73013, United States
Lynn Institute of Norman
Norman, Oklahoma, 73072, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
DelRicht Research
Tulsa, Oklahoma, 74133, United States
Tekton Research
Yukon, Oklahoma, 73099, United States
Velocity Clinical Research, Grants Pass (Research Facility)
Grants Pass, Oregon, 97527, United States
Velocity Clinical Research - Medford
Medford, Oregon, 97504, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Premier Neurology Research, P.C.
Greer, South Carolina, 29650, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Tekton Research (Research Facility)
Austin, Texas, 78705, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
ACRC Trials
Austin, Texas, 78735, United States
ACRC Trials
Carrollton, Texas, 75010, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, 78613, United States
Ventavia Research Group
Fort Worth, Texas, 76104, United States
Accurate Clinical Management - Houston
Houston, Texas, 77065, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Humble, Texas, 77064, United States
Ventavia Research Group - Keller
Keller, Texas, 76248, United States
ACRC Trials
Plano, Texas, 75024, United States
Alpine Research Organization
Clinton, Utah, 84015, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Alliance for Multispecialty Research, LLC - AMR Norfolk
Norfolk, Virginia, 23502, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Related Publications (1)
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.
PMID: 37948006BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2021
First Posted
November 19, 2021
Study Start
December 6, 2021
Primary Completion
May 23, 2023
Study Completion
May 23, 2023
Last Updated
June 28, 2024
Results First Posted
June 18, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.