Phase 4
Completed N=580
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
Source: ClinicalTrials.gov NCT05127486 ↗Enrolled (actual)
580
Serious AEs
0.2%
Results posted
Jun 2024
Primary outcomePrimary: Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. — 62; 61 percentage of participants — p=0.695
◆ Published Evidence
Established
43citations · ~22 / year
Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial.
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.
Linked Publications
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Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. |
62; 61 | 0.695 |
| SECONDARY Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period. |
37; 33 | — |
| SECONDARY Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period. |
18; 15 | — |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period. |
-4.75; -4.39 | — |
| SECONDARY Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1 |
-4.33; -3.77 | — |
| SECONDARY Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2 |
-4.81; -4.44 | — |
| SECONDARY Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3 |
-5.13; -4.94 | — |
| 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. |
-3.95; -3.47 | — |
| SECONDARY Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3 |
28.92; 24.53; 31.90; 26.66; 24.62; 20.74 | — |
| SECONDARY Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 |
-22.54; -20.11 | — |
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)
Data sourced from ClinicalTrials.gov (NCT05127486) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.