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MigrainePhase 4CHALLENGE-MIGNCT05127486

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

A Phase 4 study testing Galcanezumab and Rimegepant in people with Migraine and Episodic Migraine, run by Eli Lilly and Company at 77 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine, Episodic Migraine
What is being tested?
Galcanezumab and Rimegepant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
580 participants
Where
77 sitesUnited States
Study dates
6 Dec 2021to 23 May 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Dent Neurosciences Research Center (Research Facility)

    Amherst, New York, 14226

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, 48104

  • DelRicht Research

    Atlanta, Georgia, 30329

  • Tekton Research (Research Facility)

    Austin, Texas, 78705

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • ACRC Trials

    Austin, Texas, 78735

  • American Health Network of Indiana, LLC - Avon

    Avon, Indiana, 46123

  • Velocity Clinical Research, Banning

    Banning, California, 99202

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718

  • ACRC Trials

    Carrollton, Texas, 75010

  • Velocity Clinical Research, Austin

    Cedar Park, Texas, 78613

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459

  • Chicago Headache Center

    Chicago, Illinois, 60657

  • Velocity Clinical Research, Chula Vista

    Chula Vista, California, 91911

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Alpine Research Organization

    Clinton, Utah, 84015

  • AMR Miami

    Coral Gables, Florida, 33134

  • DelRicht Research

    Covington, Louisiana, 70433

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • Accel Research Sites- Clinical Research Unit

    DeLand, Florida, 32720

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • Tekton Research

    Edmond, Oklahoma, 73013

  • Alliance for Multispecialty Research, LLC El Dorado

    El Dorado, Kansas, 67042

  • Wr- Pri, Llc

    Encino, California, 91316

  • Deaconess Clinic

    Evansville, Indiana, 47713

  • Ventavia Research Group

    Fort Worth, Texas, 76104

  • Gilbert Neurology

    Gilbert, Arizona, 85297

  • Velocity Clinical Research, Grants Pass (Research Facility)

    Grants Pass, Oregon, 97527

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Premier Neurology Research, P.C.

    Greer, South Carolina, 29650

  • MedPharmics, LLC

    Gulfport, Mississippi, 39503

  • Velocity Clinical Research, Hallandale Beach

    Hallandale, Florida, 33009

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut, 06517

  • Healthcare Research Network - St. Louis

    Hazelwood, Missouri, 63042

  • Accurate Clinical Management - Houston

    Houston, Texas, 77065

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Humble, Texas, 77064

  • Ventavia Research Group - Keller

    Keller, Texas, 76248

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • Accel Research Sites-LKD CRU

    Lakeland, Florida, 33803

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119

  • Alliance for Multispecialty Research, LLC Lexington

    Lexington, Kentucky, 40509

  • California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)

    Los Angeles, California, 90067

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504

  • Visionary Investigators Network

    Miami, Florida, 33176

  • Visionary Investigators Network

    Miami, Florida, 33180

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Better Health Clinical Research

    Newnan, Georgia, 30265

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Alliance for Multispecialty Research, LLC - AMR Norfolk

    Norfolk, Virginia, 23502

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Foothills Research Center / CCT Research

    Phoenix, Arizona, 85044

  • ACRC Trials

    Plano, Texas, 75024

  • DelRicht Research

    Prairieville, Louisiana, 70769

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Anderson Clinical Research

    Redlands, California, 92374

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Center for Clinical Trials of Sacramento

    Sacramento, California, 95823

  • Velocity Clinical Research, Huntington Park

    Santa Ana, California, 92704

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • University of South Florida

    Tampa, Florida, 33612

  • Alliance for Multispecialty Research, LLC Tempe

    Tempe, Arizona, 85281

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • DelRicht Research

    Tulsa, Oklahoma, 74133

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Tekton Research

    Yukon, Oklahoma, 73099

Other trials in United States

About this study

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

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.

Being tested
Galcanezumab, Rimegepant, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalcanezumabDrug

    Also called LY2951742

    Administered SC.

  • RimegepantDrug

    Administered orally.

  • PlaceboDrug

    Administered orally.

  • PlaceboDrug

    Administered SC.

Study groups in NCT05127486
Study groupRoleWhat they receive
GalcanezumabExperimentalParticipants 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.
Receives: Drug: Galcanezumab; Drug: Placebo
RimegepantActive 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.
Receives: Drug: Rimegepant; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Month 1 through Month 3

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, Month 1 through Month 3

  2. 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.

    Measured: Baseline, Month 1 through Month 3

  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.

    Measured: Baseline, Month 1 through Month 3

  4. 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.

    Measured: Baseline, Month 1

  5. 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.

    Measured: Baseline, Month 2

  6. 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.

    Measured: Baseline, Month 3

  7. 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.

    Measured: Baseline, Month 1 through Month 3

  8. 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.

    Measured: Baseline, Month 3

  9. 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.

    Measured: Baseline, Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start6 Dec 2021
  3. Primary completion23 May 2023
  4. Study completion23 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05127486
Sponsor's protocol ID
18256
Other IDs
I5Q-MC-CGBD
Acronym
CHALLENGE-MIG
Status last verified
Jun 2024
First submitted
3 Nov 2021
Last updated
28 Jun 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 37948006

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Galcanezumab and Rimegepant in people with Migraine and Episodic Migraine, run by Eli Lilly and Company at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. (time frame: Baseline, Month 1 through Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05127486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.

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