Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study

Last updated: June 10, 2020
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT02614183
15767
I5Q-MC-CGAG
  • 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 episodic migraine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year priorto screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 MigraineHeadache Days (MHD).

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 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: 862
Study Start date:
November 30, 2015
Estimated Completion Date:
August 09, 2018

Connect with a study center

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Brampton, L6T 0G1
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Kelowna, V1Y 1Z9
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Mississauga, L4Y 2N8
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Montreal, H3A 2B4
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Ottawa, K2G 6E2
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Sherbrooke, J1H1Z1
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Toronto, M9W 4L6
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Vancouver, V6Z 2E8
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Waterloo, N2J 1C4
    Canada

    Site Not Available

  • Office of Dr. Ruddy Guerra

    Manati, 00674
    Puerto Rico

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  • NuFrontiers Clinical Research LLC

    Rio Piedras, 00923
    Puerto Rico

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    San Juan, 00909
    Puerto Rico

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    San Juan, 00909
    Puerto Rico

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  • Instituto de Neurologia Dra. Ivonne Fraga

    San Juan, 00918
    Puerto Rico

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    Encino, California 91316
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    Encino, California 91436
    United States

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    Fullerton, California 92835
    United States

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    Imperial, California 92251
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    Irvine, California 92618
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    Los Alamitos, California 90720
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    Denver, Colorado 80218
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    Englewood, Colorado 80113
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    Fort Collins, Colorado 80528
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    Waterbury, Connecticut 06708
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    Bradenton, Florida 34201
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    New Port Richey, Florida 34652
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    Ocala, Florida 34471
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    Ocoee, Florida 34761
    United States

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    Orlando, Florida 32801
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    Oviedo, Florida 32765
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    Port Orange, Florida 32129
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    Sarasota, Florida 34243
    United States

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    Sunrise, Florida 33351
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    West Palm Beach, Florida 33407
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    Boise, Idaho 83642
    United States

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    Meridian, Idaho 83642
    United States

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  • Healthcare Research Network - Blue Island

    Blue Island, Illinois 60406
    United States

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  • Robbins Headache Clinic

    Riverwoods, Illinois 60015
    United States

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    Anderson, Indiana 46011
    United States

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  • Investigative Clinical Research of Indiana, LLC

    Elwood, Indiana 46036
    United States

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  • Midwest Institute for Clinical Research

    Indianapolis, Indiana 46260
    United States

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    Newburgh, Indiana 47630
    United States

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    West Des Moines, Iowa 50265
    United States

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    Prairie Village, Kansas 66206
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    Edgewood, Kentucky 41017
    United States

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    Louisville, Kentucky 40213
    United States

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    Baltimore, Maryland 21208
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    Boston, Massachusetts 02131
    United States

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  • Michigan Head, Pain and Neurological Institute

    Ann Arbor, Michigan 48104
    United States

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  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

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    Springfield, Missouri 65807
    United States

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  • Healthy Perspectives Innovative Mental Health Services, PL

    Nashua, New Hampshire 03060
    United States

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    Albuquerque, New Mexico 87102
    United States

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  • Dent Neurological Institute

    Amherst, New York 14226
    United States

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  • Central New York Clinical Research

    Manlius, New York 13104
    United States

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  • Fieve Clincial Services

    New York, New York 10168
    United States

    Site Not Available

  • NYU Langone

    New York, New York 10016
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Site Not Available

  • Metrolina Neurological Associates, PA

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Headache Wellness Center

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • Rapid Medical Research Inc

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Medical College of Ohio at Toledo

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Healthcare Research Consultant

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Summit Research Network Inc

    Portland, Oregon 97210
    United States

    Site Not Available

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Abington Neurological Associates

    Willow Grove, Pennsylvania 19090
    United States

    Site Not Available

  • Omega Medical Research

    Warwick, Rhode Island 02886
    United States

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  • Clinical Trials of South Carolina

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • 8 Medical Park

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • ClinSearch

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

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  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

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    Austin, Texas 78731
    United States

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  • Protenium Clinical Research

    Hurst, Texas 76054
    United States

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  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

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    San Antonio, Texas 78229
    United States

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  • Advanced Clinical Research

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

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  • Clinical Research Associates of Tidewater

    Norfolk, Virginia 23507
    United States

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  • National Clinical Research - Richmond

    Richmond, Virginia 23294
    United States

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  • Premier Clinical Research

    Spokane, Washington 99202
    United States

    Site Not Available

  • Vancouver Clinic

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Clinical Investigation Specialists Inc

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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