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

Completed · Phase 4 · Has a placebo group

Conditions studied: Migraine, Episodic Migraine

In brief

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.

Key facts

Study ID

NCT05127486

Run by

Eli Lilly and Company

People needed

580

Starts

2021-12-06

Expected to finish

2023-05-23

Last updated by the study team

2024-06-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)

Where it is running

• 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
• Anderson Clinical Research — Redlands, California, United States
• Center for Clinical Trials of Sacramento — Sacramento, California, United States
• Velocity Clinical Research, Huntington Park — Santa Ana, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• CMR of Greater New Haven, LLC — Hamden, Connecticut, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• AMR Miami — Coral Gables, Florida, United States
• Accel Research Sites- Clinical Research Unit — DeLand, Florida, United States
• Velocity Clinical Research, Hallandale Beach — Hallandale, Florida, United States
• Accel Research Sites-LKD CRU — Lakeland, Florida, United States
• Visionary Investigators Network — Miami, Florida, United States
• Visionary Investigators Network — Miami, Florida, United States
• Sensible Healthcare, LLC — Ocoee, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Gilbert Neurology — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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