Evaluation of Galcanezumab in the Prevention of Chronic Migraine

Last updated: April 25, 2022
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Migraine (Pediatric)

Migraine And Cluster Headaches

Migraine (Adult)

Treatment

N/A

Clinical Study ID

NCT02614261
15769
I5Q-MC-CGAI
2015-001883-21
  • Ages 18-65
  • All Genders

Study Summary

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.

Eligibility Criteria

Inclusion

Inclusion Criteria: Main Study:

  • Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior toscreening, and migraine onset prior to age 50. Israel addendum:
  • Participants must have completed all phases of main study, including the 4-monthpost-treatment follow-up phase, during which no investigational product wasadministered.
  • Participants also must be considered by the investigator to have benefited fromgalcanezumab treatment and must have exhausted alternative therapies for theprevention of migraine.

Exclusion

Exclusion Criteria:

  • Are currently enrolled in or have participated within the last 30 days or within 5half-lives (whichever is longer) in a clinical trial involving an investigationalproduct.
  • Current use or prior exposure to galcanezumab or another calcitonin gene-relatedpeptide (CGRP) antibody.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeuticproteins, or to galcanezumab.
  • History of persistent daily headache, cluster headache or migraine subtypes includinghemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migrainewith brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

Study Design

Total Participants: 1117
Study Start date:
November 30, 2015
Estimated Completion Date:
July 14, 2021

Connect with a study center

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    Buenos Aires, C1056ABJ
    Argentina

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    Caba, C1425BWO
    Argentina

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    Ciudad Autonoma de Buenos Aire, C1012AAR
    Argentina

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    Cordoba, X5021FPQ
    Argentina

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    Porto Alegre, 90020-990
    Brazil

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    Tel Aviv Jaffa, 6423906
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    Amsterdam, 1078 VV
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  • Northwest Clinical Research Center

    Bellevue, Washington 98007-4209
    United States

    Site Not Available

  • Premier Clinical Research

    Spokane, Washington 99202
    United States

    Site Not Available

  • Dean Foundation for Health Research and Education

    Middleton, Wisconsin 53562
    United States

    Site Not Available

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