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

  • days left to enroll
  • participants needed
  • sponsor
    Eli Lilly and Company
Updated on 21 October 2022
episodic migraine


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.

Condition Migraine, Episodic Migraine
Treatment Placebo, Galcanezumab, Rimegepant
Clinical Study IdentifierNCT05127486
SponsorEli Lilly and Company
Last Modified on21 October 2022


Yes No Not Sure

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(CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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