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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Episodic Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: Galcanezumab; Drug: Rimegepant

• Study Type: Interventional
• Enrollment (Actual): 580
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Gilbert Neurology
    • Phoenix, Arizona, United States, 85044
      • Foothills Research Center / CCT Research
    • Tempe, Arizona, United States, 85281
      • Alliance for Multispecialty Research, LLC Tempe
  • California
    • Banning, California, United States, 99202
      • Velocity Clinical Research, Banning
    • Chula Vista, California, United States, 91911
      • Velocity Clinical Research, Chula Vista
    • Encino, California, United States, 91316
      • Wr- Pri, Llc
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research, San Diego
    • Los Angeles, California, United States, 90067
      • California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • North Hollywood, California, United States, 91606
      • Velocity Clinical Research, North Hollywood
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • Sacramento, California, United States, 95823
      • Center for Clinical Trials of Sacramento
    • Santa Ana, California, United States, 92704
      • Velocity Clinical Research, Huntington Park
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • CMR of Greater New Haven, LLC
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
    • Coral Gables, Florida, United States, 33134
      • AMR Miami
    • DeLand, Florida, United States, 32720
      • Accel Research Sites- Clinical Research Unit
    • Hallandale Beach, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach
    • Lakeland, Florida, United States, 33803
      • Accel Research Sites-LKD CRU
    • Miami, Florida, United States, 33180
      • Visionary Investigators Network
    • Miami, Florida, United States, 33176
      • Visionary Investigators Network
    • Ocoee, Florida, United States, 34761
      • Sensible HealthCare, LLC
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • DelRicht Research
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana, LLC - Avon
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • Alliance for Multispecialty Research, LLC El Dorado
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispecialty Research, LLC Lexington
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70124
      • DelRicht Research
    • Prairieville, Louisiana, United States, 70769
      • DelRicht Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Headache & Neurological Institute
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • MedPharmics, LLC
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network - St. Louis
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Research, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center (Research Facility)
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuroscience Research Center, LLC
    • Centerville, Ohio, United States, 45459
      • Dayton Center for Neurological Disorders
    • Dayton, Ohio, United States, 45459
      • Neurology Diagnostics, Inc.
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Tekton Research
    • Norman, Oklahoma, United States, 73072
      • Lynn Institute of Norman
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74133
      • DelRicht Research
    • Yukon, Oklahoma, United States, 73099
      • Tekton Research
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Velocity Clinical Research, Grants Pass (Research Facility)
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research - Medford
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC
    • Greer, South Carolina, United States, 29650
      • Premier Neurology Research, P.C.
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Austin, Texas, United States, 78735
      • ACRC Trials
    • Austin, Texas, United States, 78705
      • Tekton Research (Research Facility)
    • Carrollton, Texas, United States, 75010
      • ACRC Trials
    • Cedar Park, Texas, United States, 78613
      • Velocity Clinical Research, Austin
    • Fort Worth, Texas, United States, 76104
      • Ventavia Research Group
    • Houston, Texas, United States, 77065
      • Accurate Clinical Management - Houston
    • Humble, Texas, United States, 77064
      • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Keller, Texas, United States, 76248
      • Ventavia Research Group - Keller
    • Plano, Texas, United States, 75024
      • ACRC Trials
  • Utah
    • Clinton, Utah, United States, 84015
      • Alpine Research Organization
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Alliance for Multispecialty Research, LLC - AMR Norfolk
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Placebo; Administered SC.; Drug: Placebo; Administered orally.; Drug: Galcanezumab; Administered SC.; Other Names: LY2951742
Active Comparator: 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.	Drug: Placebo; Administered SC.; Drug: Placebo; Administered orally.; Drug: Rimegepant; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With 75% 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 75% reduction in monthly migraine headache days from baseline (75% 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
Percentage of Participants With 100% 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 100% reduction in monthly migraine headache days from baseline (100% 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
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days 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 was derived from the average of month 1 through month 3. Least square (LS) mean was calculated using mixed model for repeated measures (MMRM) model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.	Baseline, Month 1 through Month 3
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1	A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.	Baseline, Month 1
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2	A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.	Baseline, Month 2
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3	A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables.	Baseline, Month 3
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache Across the 3-month Treatment Period.	Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean was derived from the average of month 1 through month 3. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days with acute medications use, and baseline-by-month interaction as continuous variables.	Baseline, Month 1 through Month 3
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3	The MSQ v2.1 is a 14-item questionnaire, participant-rated scale with a 4-week recall period that measures the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains: Role Function-Restrictive (RF-R), items 1-7; Role Function-Preventive (RF-P), items 8-11; Emotional Function (EF), items 12-14 Each item is scored from 1 (none of the time) to 6 (all of the time) and are reverse coded (value 6 to 1). Raw scores for each domain are computed as a sum of item responses, with the collective sum providing a total raw score. These were transformed to a 0-100 scale, with higher scores indicating better quality of life. LS mean was calculated using Analysis of covariance (ANCOVA) with main effects of treatment, the baseline number of migraine headache days category (<8 vs >=8), and the continuous fixed covariate of the baseline endpoint.	Baseline, Month 3
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3	The MIDAS is a participant-rated scale that measures headache-related disability over a 3-month period. It consists of 5 items that measures number of days of work/school missed or days with productivity at work/school reduced to half or more; days with household work missed or days with productivity in household work reduced to half or more, and days of missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean was calculated using ANCOVA model with main effects of treatment, the baseline number of migraine headache days category (<8 vs >=8), and the continuous fixed covariate of the baseline endpoint.	Baseline, Month 3

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine (CHALLENGE-MIG)

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 18256; I5Q-MC-CGBD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No