Clinical trial NCT05127486: A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Episodic Migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)

Primary outcomes:
measure: Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period.
timeFrame: Baseline, Month 1 through Month 3
Secondary outcomes:
measure: Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period.
timeFrame: Baseline, Month 1 through Month 3
measure: Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period.
timeFrame: Baseline, Month 1 through Month 3
measure: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period.
timeFrame: Baseline, Month 1 through Month 3
measure: Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1
timeFrame: Baseline, Month 1
measure: Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2
timeFrame: Baseline, Month 2
measure: Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3
timeFrame: Baseline, Month 3
measure: 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.
timeFrame: Baseline, Month 1 through Month 3
measure: Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Gilbert Neurology
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center / CCT Research
state: Arizona
city: Tempe
country: United States
facility: Alliance for Multispecialty Research, LLC Tempe
state: Arizona
city: Banning
country: United States
facility: Velocity Clinical Research, Banning
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research, Chula Vista
state: California
city: Encino
country: United States
facility: Wr- Pri, Llc
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Los Angeles
country: United States
facility: California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Sacramento
country: United States
facility: Center for Clinical Trials of Sacramento
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Coral Gables
country: United States
facility: AMR Miami
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites- Clinical Research Unit
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites-LKD CRU
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: DelRicht Research
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Chicago Headache Center
state: Illinois
city: Avon
country: United States
facility: American Health Network of Indiana, LLC - Avon
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research, LLC El Dorado
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC Lexington
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Covington
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Hazelwood
country: United States
facility: Healthcare Research Network - St. Louis
state: Missouri
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Nevada
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurosciences Research Center (Research Facility)
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Canton
country: United States
facility: NeuroScience Research Center, LLC
state: Ohio
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics, Inc.
state: Ohio
city: Edmond
country: United States
facility: Tekton Research
state: Oklahoma
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: DelRicht Research
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research, Grants Pass (Research Facility)
state: Oregon
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Greer
country: United States
facility: Premier Neurology Research, P.C.
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: Tekton Research (Research Facility)
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: ACRC Trials
state: Texas
city: Carrollton
country: United States
facility: ACRC Trials
state: Texas
city: Cedar Park
country: United States
facility: Velocity Clinical Research, Austin
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management - Houston
state: Texas
city: Humble
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group - Keller
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC - AMR Norfolk
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.