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

Phase 4

Completed

Conditions: Migraine
Episodic Migraine

Interventions: Drug: Galcanezumab
Drug: Rimegepant
Drug: Placebo

Registration Number: NCT05127486

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 580

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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Galcanezumab	Placebo	Participants 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.
Rimegepant	Placebo	Participants 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.
Galcanezumab	Galcanezumab	Participants 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.
Rimegepant	Rimegepant	Participants 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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period.	Baseline, Month 1 through Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period.	Baseline, Month 1 through Month 3	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.
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1	Baseline, 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.
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2	Baseline, 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.
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3	Baseline, 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.
Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period.	Baseline, Month 1 through Month 3	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.
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period.	Baseline, Month 1 through Month 3	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.
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.	Baseline, Month 1 through Month 3	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.
Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3	Baseline, 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.
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3	Baseline, 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.

Trial Locations

Locations (68): Gilbert Neurology
🇺🇸
Gilbert, Arizona, United States
Foothills Research Center / CCT Research
🇺🇸
Phoenix, Arizona, United States
Alliance for Multispecialty Research, LLC Tempe
🇺🇸
Tempe, Arizona, United States
Velocity Clinical Research, Banning
🇺🇸
Banning, California, United States
Velocity Clinical Research, Chula Vista
🇺🇸
Chula Vista, California, United States
Wr- Pri, Llc
🇺🇸
Encino, California, United States
Velocity Clinical Research, San Diego
🇺🇸
La Mesa, California, United States
California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)
🇺🇸
Los Angeles, California, United States
Pharmacology Research Institute
🇺🇸
Newport Beach, California, United States
Velocity Clinical Research, North Hollywood
🇺🇸
North Hollywood, California, United States
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Gilbert Neurology
🇺🇸Gilbert, Arizona, United States