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 | August 2023 |
| 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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody) |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,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Monthly Percentage of Participants with a 50% Response Rate | 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 | Month 1 through Month 3 | |
| Secondary | Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days | Overall mean change from baseline in the number of monthly migraine headache days | Baseline, Month 1 through Month 3 | |
| Secondary | Mean Monthly Percentage of Participants with a 75% Response Rate | 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 | Month 1 through Month 3 | |
| Secondary | Mean Change from Baseline in the Number of Monthly Migraine Headache Days | Mean change from baseline in the number of monthly migraine headache days | Baseline, 1 Month | |
| Secondary | Mean Change from Baseline in the Number of Monthly Migraine Headache Days | Mean change from baseline in the number of monthly migraine headache days | Baseline, 2 Months | |
| Secondary | Mean Change from Baseline in the Number of Monthly Migraine Headache Days | Mean change from baseline in the number of monthly migraine headache days | Baseline, 3 Months | |
| Secondary | Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache | 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 | |
| Secondary | 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) | 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 | |
| Secondary | Mean Monthly Percentage of Participants with a 100% Response Rate | 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 | Month 1 through Month 3 | |
| Secondary | Change from Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Total Score | Change from baseline in MSQ v2.1 total score | Baseline, 3 Months | |
| Secondary | Change from baseline in Role Function-Preventive (RF-P) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) | Change from baseline in RF-P Domain Score of MSQ v2.1 | Baseline, 3 Months | |
| Secondary | Change from Baseline in Emotional Function (EF) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) | Change from baseline in EF domain score of MSQ v2.1 | Baseline, 3 Months | |
| Secondary | Change from Baseline in MIDAS (Migraine Disability Assessment) Total Score | Change from baseline in MIDAS total score | Baseline, 3 Months |
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