Migraine Clinical Trial
— CHALLENGE-MIGOfficial 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
| Verified date | May 2024 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 587 |
| Est. completion date | May 23, 2023 |
| Est. primary completion date | May 23, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico |
| United States | Dent Neurosciences Research Center (Research Facility) | Amherst | New York |
| United States | Michigan Headache & Neurological Institute | Ann Arbor | Michigan |
| United States | DelRicht Research | Atlanta | Georgia |
| United States | ACRC Trials | Austin | Texas |
| United States | FutureSearch Trials of Neurology | Austin | Texas |
| United States | Tekton Research (Research Facility) | Austin | Texas |
| United States | American Health Network of Indiana, LLC - Avon | Avon | Indiana |
| United States | Velocity Clinical Research, Banning | Banning | California |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Boston Clinical Trials | Boston | Massachusetts |
| United States | NeuroScience Research Center, LLC | Canton | Ohio |
| United States | ACRC Trials | Carrollton | Texas |
| United States | Velocity Clinical Research, Austin | Cedar Park | Texas |
| United States | Dayton Center for Neurological Disorders | Centerville | Ohio |
| United States | Chicago Headache Center | Chicago | Illinois |
| United States | Velocity Clinical Research, Chula Vista | Chula Vista | California |
| United States | Innovative Research of West Florida | Clearwater | Florida |
| United States | Alpine Research Organization | Clinton | Utah |
| United States | AMR Miami | Coral Gables | Florida |
| United States | DelRicht Research | Covington | Louisiana |
| United States | Neurology Diagnostics, Inc. | Dayton | Ohio |
| United States | Accel Research Sites- Clinical Research Unit | DeLand | Florida |
| United States | Velocity Clinical Research, Providence | East Greenwich | Rhode Island |
| United States | Tekton Research | Edmond | Oklahoma |
| United States | Alliance for Multispecialty Research, LLC El Dorado | El Dorado | Kansas |
| United States | Wr- Pri, Llc | Encino | California |
| United States | Deaconess Clinic | Evansville | Indiana |
| United States | Ventavia Research Group | Fort Worth | Texas |
| United States | Gilbert Neurology | Gilbert | Arizona |
| United States | Velocity Clinical Research, Grants Pass (Research Facility) | Grants Pass | Oregon |
| United States | Tribe Clinical Research, LLC | Greenville | South Carolina |
| United States | Premier Neurology Research, P.C. | Greer | South Carolina |
| United States | MedPharmics, LLC | Gulfport | Mississippi |
| United States | Velocity Clinical Research, Hallandale Beach | Hallandale Beach | Florida |
| United States | CMR of Greater New Haven, LLC | Hamden | Connecticut |
| United States | Healthcare Research Network - St. Louis | Hazelwood | Missouri |
| 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 | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee |
| United States | Velocity Clinical Research, San Diego | La Mesa | California |
| United States | Accel Research Sites-LKD CRU | Lakeland | Florida |
| United States | Alliance for Multispecialty Research, LLC | Las Vegas | Nevada |
| United States | Alliance for Multispecialty Research, LLC Lexington | Lexington | Kentucky |
| United States | California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility) | Los Angeles | California |
| United States | L-MARC Research Center | Louisville | Kentucky |
| United States | Velocity Clinical Research - Medford | Medford | Oregon |
| United States | Visionary Investigators Network | Miami | Florida |
| United States | Visionary Investigators Network | Miami | Florida |
| United States | Clinical Research Associates | Nashville | Tennessee |
| United States | DelRicht Research | New Orleans | Louisiana |
| United States | Better Health Clinical Research | Newnan | Georgia |
| United States | Pharmacology Research Institute | Newport Beach | California |
| United States | Alliance for Multispecialty Research, LLC - AMR Norfolk | Norfolk | Virginia |
| United States | Lynn Institute of Norman | Norman | Oklahoma |
| United States | Coastal Carolina Research Center | North Charleston | South Carolina |
| United States | Velocity Clinical Research, North Hollywood | North Hollywood | California |
| United States | Sensible Healthcare, LLC | Ocoee | Florida |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Foothills Research Center / CCT Research | Phoenix | Arizona |
| United States | ACRC Trials | Plano | Texas |
| United States | DelRicht Research | Prairieville | Louisiana |
| United States | North Carolina Clinical Research | Raleigh | North Carolina |
| United States | Anderson Clinical Research | Redlands | California |
| United States | Rochester Clinical Research, Inc. | Rochester | New York |
| United States | Center for Clinical Trials of Sacramento | Sacramento | California |
| United States | Velocity Clinical Research, Huntington Park | Santa Ana | California |
| United States | Meridian Clinical Research | Savannah | Georgia |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | University of South Florida | Tampa | Florida |
| United States | Alliance for Multispecialty Research, LLC Tempe | Tempe | Arizona |
| United States | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan |
| United States | DelRicht Research | Tulsa | Oklahoma |
| United States | Advanced Clinical Research | West Jordan | Utah |
| United States | Palm Beach Research Center | West Palm Beach | Florida |
| United States | Tekton Research | Yukon | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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