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

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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)

• Have a history of 4 to 14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months.

• During the prospective baseline period, have a frequency of 4 to 14 migraine headache days and at least 2 migraine attacks

Exclusion Criteria:

• Have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, or to multiple drugs, 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 active or unstable psychiatric disease by medical history, such as bipolar disorder, schizophrenia, personality disorders, or other serious mood or anxiety disorders.

• Women who are pregnant or nursing

• Participants currently on monoclonal antibodies (mAb) calcitonin gene-related peptide (CGRP) antagonists or have prior exposure to a mAb CGRP antagonist