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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05127486
Collaborator
(none)
700
Enrollment
83
Locations
2
Arms
12.8
Anticipated Duration (Months)
8.4
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine
Actual Study Start Date :
Dec 6, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Galcanezumab

Galcanezumab administered subcutaneously (SC). Placebo for rimegepant will be used for blinding.

Drug: Galcanezumab
Administered SC
Other Names:
  • LY2951742

    • Drug: Placebo
    Administered ODT
    Active Comparator: Rimegepant

    Rimegepant administered oral disintegrating tablets (ODT). Placebo for galcanezumab will be used for blinding.

    Drug: Rimegepant
    Administered ODT

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Mean Monthly Percentage of Participants with a 50% Response Rate [Month 1 through Month 3]

      The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with ≥50% reduction from baseline in monthly migraine headache days

    Secondary Outcome Measures

    1. Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days [Baseline, Month 1 through Month 3]

      Overall mean change from baseline in the number of monthly migraine headache days

    2. Mean Monthly Percentage of Participants with a 75% Response Rate [Month 1 through Month 3]

      The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with ≥75% reduction from baseline in monthly migraine headache days

    3. Mean Change from Baseline in the Number of Monthly Migraine Headache Days [Baseline, 1 Month]

      Mean change from baseline in the number of monthly migraine headache days

    4. Mean Change from Baseline in the Number of Monthly Migraine Headache Days [Baseline, 2 Months]

      Mean change from baseline in the number of monthly migraine headache days

    5. Mean Change from Baseline in the Number of Monthly Migraine Headache Days [Baseline, 3 Months]

      Mean change from baseline in the number of monthly migraine headache days

    6. Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache [Baseline, Month 1 through 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

    7. Mean Change from Baseline in the Role Function-Restrictive (RF-R) Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) [Baseline, 3 Months]

      Mean Change from Baseline in the Role Function-Restrictive (RF-R) domain score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)

    8. Mean Monthly Percentage of Participants with a 100% Response Rate [Month 1 through Month 3]

      The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with 100% reduction from baseline in monthly migraine headache days

    9. Change from Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Total Score [Baseline, 3 Months]

      Change from baseline in MSQ v2.1 total score

    10. Change from baseline in Role Function-Preventive (RF-P) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) [Baseline, 3 Months]

      Change from baseline in RF-P Domain Score of MSQ v2.1

    11. Change from Baseline in Emotional Function (EF) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) [Baseline, 3 Months]

      Change from baseline in EF domain score of MSQ v2.1

    12. Change from Baseline in MIDAS (Migraine Disability Assessment) Total Score [Baseline, 3 Months]

      Change from baseline in MIDAS total score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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, or to multiple drugs, 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gilbert Neurology Gilbert Arizona United States 85297
    2 Foothills Research Center / CCT Research Phoenix Arizona United States 85044
    3 Alliance for Multispecialty Research, LLC Tempe Tempe Arizona United States 85281
    4 Velocity Clinical Research, Banning Banning California United States 99202
    5 Velocity Clinical Research, Chula Vista Chula Vista California United States 91911
    6 Wr- Pri, Llc Encino California United States 91316
    7 Paradigm Clinical Research La Mesa California United States 91942
    8 Velocity Clinical Research, San Diego La Mesa California United States 91942
    9 California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility) Los Angeles California United States 90067
    10 Pharmacology Research Institute Newport Beach California United States 92660
    11 Velocity Clinical Research - North Hollywood North Hollywood California United States 91606
    12 Anderson Clinical Research Redlands California United States 92374
    13 Center for Clinical Trials of Sacramento Sacramento California United States 95823
    14 Velocity Clinical Research, Huntington Park Santa Ana California United States 92704
    15 Encompass Clinical Research Spring Valley California United States 91978
    16 CMR of Greater New Haven Hamden Connecticut United States 06517
    17 SFM Clinical Research Boca Raton Florida United States 33487
    18 Innovative Research of West Florida Clearwater Florida United States 33756
    19 AMR Miami Coral Gables Florida United States 33134
    20 Accel Research Sites- Clinical Research Unit DeLand Florida United States 32720
    21 Velocity Clinical Research, Hallandale Beach Hallandale Beach Florida United States 33009
    22 Health Awareness, Inc Jupiter Florida United States 33458
    23 Accel Research Sites-LKD CRU Lakeland Florida United States 33803
    24 Visionary Investigators Network Miami Florida United States 33176
    25 Visionary Investigators Network Miami Florida United States 33180
    26 Sensible Healthcare, LLC Ocoee Florida United States 34761
    27 Advanced Research Consultants Palm Beach Gardens Florida United States 33410
    28 University of South Florida Tampa Florida United States 33612
    29 Palm Beach Research Center West Palm Beach Florida United States 33409
    30 Better Health Clinical Research Newnan Georgia United States 30265
    31 Meridian Clinical Research Savannah Georgia United States 31406
    32 Chicago Headache Center Chicago Illinois United States 60657
    33 American Health Network of Indiana, LLC - Avon Avon Indiana United States 46123
    34 Deaconess Clinic Evansville Indiana United States 47713
    35 Alliance for Multispecialty Research, LLC El Dorado El Dorado Kansas United States 67042
    36 Alliance for Multispecialty Research, LLC Lexington Lexington Kentucky United States 40509
    37 L-MARC Research Center Louisville Kentucky United States 40213
    38 MedPharmics, LLC Metairie Louisiana United States 70006
    39 DelRicht Research New Orleans Louisiana United States 70124
    40 DelRicht Research Prairieville Louisiana United States 70769
    41 Boston Clinical Trials Boston Massachusetts United States 02131
    42 Michigan Headache & Neurological Institute Ann Arbor Michigan United States 48104
    43 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy Michigan United States 48098
    44 MedPharmics, LLC Gulfport Mississippi United States 39503
    45 Citizens Memorial Hospital District Bolivar Missouri United States 65613
    46 Healthcare Research Network - St. Louis Hazelwood Missouri United States 63042
    47 Alliance for Multispecialty Research, LLC Las Vegas Nevada United States 89119
    48 Albuquerque Clinical Trials, Inc. Albuquerque New Mexico United States 87102
    49 MedPharmics, LLC Albuquerque New Mexico United States 87102
    50 Dent Neurosciences Research Center (Research Facility) Amherst New York United States 14226
    51 Rochester Clinical Research, Inc. Rochester New York United States 14609
    52 North Carolina Clinical Research Raleigh North Carolina United States 27607
    53 NeuroScience Research Center, LLC Canton Ohio United States 44718
    54 Rapid Medical Research Cleveland Ohio United States 44122
    55 Neurology Diagnostics, Inc. Dayton Ohio United States 45459
    56 Tekton Research Edmond Oklahoma United States 73013
    57 Lynn Institute of Norman Norman Oklahoma United States 73072
    58 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    59 DelRicht Research Tulsa Oklahoma United States 74133
    60 Tekton Research Yukon Oklahoma United States 73099
    61 Velocity Clinical Research, Grants Pass (Research Facility) Grants Pass Oregon United States 97527
    62 Velocity Clinical Research - Medford Medford Oregon United States 97504
    63 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    64 Premier Neurology Research, P.C. Greer South Carolina United States 29650
    65 Coastal Carolina Research Center North Charleston South Carolina United States 29405
    66 Alliance for Multispecialty Research, LLC Knoxville Tennessee United States 37920
    67 Clinical Research Associates Nashville Tennessee United States 37203
    68 Tekton Research (Research Facility) Austin Texas United States 78705
    69 FutureSearch Trials of Neurology Austin Texas United States 78731
    70 ACRC Trials Austin Texas United States 78735
    71 ACRC Trials Carrollton Texas United States 75010
    72 Velocity Clinical Research, Austin Cedar Park Texas United States 78613
    73 FutureSearch Trials of Dallas Dallas Texas United States 75231
    74 Ventavia Research Group Fort Worth Texas United States 76104
    75 Accurate Clinical Management - Houston Houston Texas United States 77065
    76 Ventavia Research Group - Keller Keller Texas United States 76248
    77 ACRC Trials Plano Texas United States 75024
    78 Dynamed Clinical Research, LP d/b/a DM Clinical Research Tomball Texas United States 77375
    79 Alpine Research Organization Clinton Utah United States 84015
    80 Advanced Clinical Research West Jordan Utah United States 84088
    81 Alliance for Multispecialty Research, LLC - AMR Norfolk Norfolk Virginia United States 23502
    82 Meridian Clinical Research Norfolk Virginia United States 23502
    83 Northwest Clinical Research Center Bellevue Washington United States 98007

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05127486
    Other Study ID Numbers:
    • 18256
    • I5Q-MC-CGBD
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Aug 18, 2022