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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine

Conditions
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Migraine, Episodic Migraine

Intervention / Treatment
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* Drug: Galcanezumab
* Drug: Placebo
* Drug: Rimegepant
* Drug: Placebo


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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galcanezumab<br>Galcanezumab administered subcutaneously (SC). Placebo for rimegepant will be used for blinding. | Drug: Galcanezumab<br>* Administered SC<br>* Other names: LY2951742;Drug: Placebo<br>* Administered ODT<br>|
| Active Comparator: Rimegepant<br>Rimegepant administered oral disintegrating tablets (ODT). Placebo for galcanezumab will be used for blinding. | Drug: Rimegepant<br>* Administered ODT<br>Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change from Baseline in MIDAS (Migraine Disability Assessment) Total Score | Change from baseline in MIDAS total score | Baseline, 3 Months |