A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 65
Updated:1/9/2019
Start Date:November 30, 2015
End Date:August 14, 2018

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A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine

The main purpose of this study is to evaluate the longer term safety of the study drug known
as galcanezumab in participants with episodic or chronic migraine.


Inclusion Criteria:

- Have a diagnosis of episodic or chronic migraine as defined by International Headache
Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta
guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at
least 1 year prior to screening, and migraine onset prior to age 50.

- Prior to baseline, a history of 4 or more migraine headache days per month on average
for the past 3 months.

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
14
sites
Clinton, Utah 84015
Principal Investigator: Corey Ericksen
Phone: 801-614-5501
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Clinton, UT
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4085 University Blvd S # 1
Jacksonville, Florida 32216
Principal Investigator: Erin Doty
Phone: 904-730-0101
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Jacksonville, FL
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Albuquerque, New Mexico 87109
Principal Investigator: Paula Lane
Phone: 505-848-3773
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Albuquerque, NM
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from
Brugge,
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Greensboro, North Carolina 27408
Principal Investigator: Randal Von Seggern
Phone: 336-574-8020
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from
Greensboro, NC
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Hollywood, Florida 33021
Principal Investigator: Harvey Schwartz
Phone: 954-366-0277
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Hollywood, FL
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Media, Pennsylvania 19063
Principal Investigator: Shivkumar Hatti
Phone: 610-891-9024
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Media, PA
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Roanoke, Virginia 24018
Principal Investigator: John Burch
Phone: 540-342-2929
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Roanoke, VA
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Saint Louis, Missouri 63141
Principal Investigator: Jo Jaeger Bonner
Phone: 314-251-8890
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Saint Louis, MO
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Santa Monica, California 90404
Principal Investigator: David Kudrow
Phone: 310-315-1456
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from
Santa Monica, CA
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Spring Valley, California 91978
Principal Investigator: Hanid Audish
Phone: 619-660-9068
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Spring Valley, CA
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Stamford, Connecticut 06905
Principal Investigator: Peter McAllister
Phone: 203-914-1903
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Stamford, CT
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Waxahachie, Texas 75165
Principal Investigator: Thomas Ledbetter
Phone: 972-961-3949
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Waxahachie, TX
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Wilmington, North Carolina 28401
Principal Investigator: Brian Averell
Phone: 910-799-5500
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Wilmington, NC
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