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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:12/1/2018
Start Date:November 30, 2015
End Date:August 9, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-1 Study

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


Inclusion Criteria:

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

Exclusion Criteria:

- Are currently enrolled in or have participated within the last 30 days or within 5
half-lives (whichever is longer) in a clinical trial involving an investigational
product.

- Current use or prior exposure to Galcanezumab or another CGRP antibody.

- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
proteins, or to Galcanezumab.

- History of persistent daily headache, cluster headache or migraine subtypes including
hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
We found this trial at
82
sites
Dent Neurological Institute
Amherst, New York 14226
Principal Investigator: Laszlo Mechtler
Phone: 716-558-5670
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Accord Clinical Research
3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
Principal Investigator: Craig Dean
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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Alpine Clinical Research Center
1000 Alpine
Boulder, Colorado 80304
303-443-7229
Principal Investigator: Paul Brownstone
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Boulder, CO
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Sun Valley Research Center
2417 Marshall Ave.
Imperial, California 92251
760-355-0176
Principal Investigator: Bernardo Ng
Phone: 760-545-0123
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Imperial, CA
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Clinical Research Associates of Tidewater
400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
Principal Investigator: Duane Wombolt
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Renstar Medical Research
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
Principal Investigator: Sidney Clevinger
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Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Douglas Denham
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Radiant Research - San Antonio
8122 Datapoint Drive
San Antonio, Texas 78229
210-614-7483
Principal Investigator: William Jennings
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Omega Medical Research
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
Principal Investigator: David Fried
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Warwick, RI
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Chase Medical Research, LLC
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
Principal Investigator: Joseph Soufer
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Albuquerque Clinical Trials
Albuquerque, New Mexico
Principal Investigator: Marigene Salazar Sharma
Phone: 505-224-7407
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Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
Principal Investigator: Paul Gross
Phone: 610-820-0342
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Community Clinical Research Center
Anderson, Indiana 46011
Principal Investigator: Larry Blankenship
Phone: 765-298-2040
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Anderson, IN
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Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan 48104
Principal Investigator: Joel Saper
Phone: 734-677-6000
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Ann Arbor, MI
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FutureSearch Trials
Austin, Texas 78731
Principal Investigator: John Hudson
Phone: 512-380-9925
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Pharmasite Research
Baltimore, Maryland 21208
Principal Investigator: Alan Jonas
Phone: 410-602-1440
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Healthcare Research Network - Blue Island
Blue Island, Illinois 60406
Principal Investigator: Charles Campbell
Phone: 312-731-6128
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Boston Clinical Trials, INC.
Boston, Massachusetts 02135
Principal Investigator: Arkadiy Stolyar Stolyar
Phone: 617-447-4868
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Meridien Research
Bradenton, Florida
Principal Investigator: Louis Chaykin
Phone: 941-756-8680
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Clinical Trial Facility in Brampton
Brampton,
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Advanced Clinical Research
Carmichael, California 95608
Principal Investigator: Nancy Coburn
Phone: 916-514-0163
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Clinical Trials of South Carolina
Charleston, South Carolina 29406
Principal Investigator: David Stickler
Phone: 843-725-5067
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Metrolina Neurological Associates, PA
Charlotte, North Carolina 28210
Principal Investigator: Mark Porter
Phone: 704-542-6698
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Charlottesville Medical Research Inc.
Charlottesville, Virginia 22911
Principal Investigator: James Clark
Phone: 434-817-2442
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ClinSearch, LLC
Chattanooga, Tennessee 37421
Principal Investigator: Richard Krause Krause
Phone: 423-698-4584
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Rapid Medical Research, Inc.
Cleveland, Ohio 44122
Principal Investigator: Mary Manning
Phone: 216-682-0320
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MCB Clinical Research Centers
Colorado Springs, Colorado 80910
Principal Investigator: Joel Dickerman
Phone: 719-634-6576
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8 Medical Park
Columbia, South Carolina 29203
Principal Investigator: Xiao Androulakis
Phone: 803-545-6089
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Mile High Research Center
Denver, Colorado 80218
Principal Investigator: Jack Klapper
Phone: 303-839-9900
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Otri-Med Corporation
Edgewood, Kentucky 41017
Principal Investigator: Pragya Gupta
Phone: 859-757-1359
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Investigative Clinical Research of Indiana, LLC
Elwood, Indiana 46036
Principal Investigator: Robert Helm
Phone: 765-557-8076
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Pharmacology Research Institute, Newport Beach
Encino, California 91316
Principal Investigator: Daniel Grosz
Phone: 818-705-7451
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Tooraj Joseph Raoof M.D., Inc.
Encino, California 91436
Principal Investigator: Tooraj Raoof
Phone: 818-788-5060
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Colorado Neurological Institute
Englewood, Colorado
Principal Investigator: Cori Millen
Phone: 720-336-4300
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Advanced Neurosciences Research, LLC
Fort Collins, Colorado 80528
Principal Investigator: Tamara Miller
Phone: 970-226-6111
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Fullerton Neurology and Headache Center
Fullerton, California 92835
Principal Investigator: Jack Florin
Phone: 714-738-3845
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Sarkis Clinical Trials
Gainesville, Florida 32607
Principal Investigator: Michael Johnson
Phone: 352-333-0094
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Headache Wellness Center
Greensboro, North Carolina 27405
Principal Investigator: Marshall Freeman
Phone: 336-574-8000
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Protenium Clinical Research
Hurst, Texas 76054
Principal Investigator: Robert Strzinek
Phone: 817-281-4156
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Midwest Institute for Clinical Research
Indianapolis, Indiana 46260
Principal Investigator: Phillip Toth
Phone: 317-705-7050
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Irvine Clinical Research Center
Irvine, California 92618
Principal Investigator: Elly Lee
Phone: 949-753-1663
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Clinical Investigation Specialists
Kenosha, Wisconsin 53142
Principal Investigator: John Agaiby
Phone: 262-925-1280
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University of Tennessee Medical Center
Knoxville, Tennessee 37920
Principal Investigator: William Smith
Phone: 865-305-9100
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Arkansas Clinical Research
Little Rock, Arkansas 72205
Principal Investigator: Kevin Roberts
Phone: 501-907-9169
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Pharmacology Research Institute, Newport Beach
Los Alamitos, California 90720
Principal Investigator: Nader Oskooilar
Phone: 714-827-3667
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L-MARC Research Center
Louisville, Kentucky 40213
Principal Investigator: Harold Bays
Phone: 502-515-5672
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Central New York Clinical Research
Manlius, New York 13104
Principal Investigator: Jon Stringer
Phone: 315-682-3263
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Advanced Clinical Research, Inc.
Meridian, Idaho 83642
Principal Investigator: Mark Turner
Phone: 208-377-8653
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Clinical Research Institute Inc.
Minneapolis, Minnesota 55402
Principal Investigator: Gary Berman
Phone: 612-333-2200
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Healthy Perspectives Innovative Mental Health Services, PL
Nashua, New Hampshire 03060
Principal Investigator: Hisham Hafez
Phone: 603-880-9880
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Clinical Research Associates
Nashville, Tennessee 37203
Principal Investigator: Stephan Sharp
Phone: 615-329-0197
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Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652
Principal Investigator: Lisa Cohen
Phone: 727-849-4131
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NYU Langone
New York, New York 10016
Principal Investigator: Sait Ashina
Phone: 212-263-7744
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Fieve Clincial Services
New York, New York 10168
Principal Investigator: Craig McCarthy
Phone: 212-772-3570
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Deaconess Clinic
Newburgh, Indiana 47630
Principal Investigator: Michelle Galen
Phone: 812-492-5011
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Pharmacology Research Institute, Newport Beach
Newport Beach, California 92660
Principal Investigator: Don De Francisco
Phone: 949-752-7910
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Sensible Healthcare
Ocoee, Florida 34761
Principal Investigator: Kelly Taylor
Phone: 407-654-2724
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Psychiatric Inst of Florida-Clinical Neuroscience Solutions
Orlando, Florida 32801
Principal Investigator: Linda Harper
Phone: 407-425-5100
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Compass Research
Oviedo, Florida 32765
Principal Investigator: Bradley Block
Phone: 407-678-6888
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Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania 15243
Principal Investigator: Nathan Bennett
Phone: 412-650-5623
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Summit Research Network
Portland, Oregon 97210
Principal Investigator: MaryAnn Colvard-Conrad
Phone: 503-279-8252
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Phoenix Medical Research
Prairie Village, Kansas 66206
Principal Investigator: Haydn Thomas
Phone: 913-381-7180
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Prairie Village, KS
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Desert Valley Research
Rancho Mirage, California 92270
Principal Investigator: Dennis Anderson
Phone: 760-464-0470
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Anderson Clinical Research
Redlands, California 92374
Principal Investigator: Donald Anderson
Phone: 909-792-9007
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National Clinical Research - Richmond, Inc.
Richmond, Virginia 23294
Principal Investigator: John Scott
Phone: 804-672-2133
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Rochester Clinical Research Inc.
Rochester, New York 14609
Principal Investigator: Matthew Davis
Phone: 585-288-0890
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Artemis Institute for Clinical Research
San Diego, California 92123
Principal Investigator: Vishaal Mehra
Phone: 858-278-3647
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Medical Center for clinical research
San Diego, California 92108
Principal Investigator: William Koltun
Phone: 619-521-2830
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Roskamp Institute
Sarasota, Florida 34243
Principal Investigator: Andrew Keegan
Phone: 941-256-8019
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Premier Clinical Research
Spokane, Washington 99204
Principal Investigator: David Greeley
Phone: 509-343-3710
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Clinvest
Springfield, Missouri 65807
Principal Investigator: Timothy Smith
Phone: 417-883-7889
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Infinity Clinical Reserach . LLC
Sunrise, Florida 33351
Principal Investigator: Barry Cutler
Phone: 954-475-4811
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Medical College of Ohio at Toledo
Toledo, Ohio 43614
Principal Investigator: Gretchen Tietjen
Phone: 419-383-6187
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Orange Grove Family Practice
Tucson, Arizona 85741
Principal Investigator: Kevin Pounds
Phone: 520-333-4515
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Territory Neurology & Research Institute
Tucson, Arizona 85704
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Healthcare Research Consultant
Tulsa, Oklahoma 74135
Principal Investigator: Jay Johnson
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The Vancouver Clinic
Vancouver, Washington 98664
Principal Investigator: Melissa Freeman
Phone: 360-253-3294
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The Vancouver Clinic
Vancouver, Washington 98664
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Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa 50265
Principal Investigator: Kenneth Pollack
Phone: 515-327-4782
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Advanced Clinical Research, Inc.
West Jordan, Utah 84088
Principal Investigator: J Kirsten
Phone: 801-542-8190
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Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida 33407
Principal Investigator: Paul Winner
Phone: 561-845-0500
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Abington Neurological Associates
Willow Grove, Pennsylvania 19090
Principal Investigator: Brad Klein
Phone: 215-957-9250
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