A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache



Status:Enrolling by invitation
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 13, 2016
End Date:August 24, 2021

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A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache

The main purpose of this study is to assess the long-term safety and tolerability of
galcanezumab administered up to once monthly in participants with episodic or chronic cluster
headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM
(NCT02438826).


Inclusion Criteria:

- Participants who participated in and completed either study CGAL or study CGAM.

- Investigator judges the participant as reliable to follow all study procedures, keep
all study visits, and be compliant with study requirements.

Exclusion Criteria:

- Current enrollment in or discontinuation within the last 30 days from, a clinical
trial involving any investigational drug or device (with the exception of Study CGAL
or Study CGAM).

- Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF)
(with the exception of Study CGAL or Study CGAM).

- A history of migraine variants that could implicate or could be confused with
ischemia.

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

- A history or presence of other medical illness that indicates a medical problem that
would preclude study participation.

- Evidence of significant active or unstable psychiatric disease, in the opinion of the
investigator.

- Women who are pregnant or nursing.
We found this trial at
15
sites
Stamford, Connecticut 06905
Principal Investigator: Peter McAllister
Phone: 203-914-1903
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Amherst, New York 14226
Principal Investigator: Laszlo Mechtler
Phone: 716-558-5670
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Ann Arbor, Michigan 48104
Principal Investigator: Joel Saper
Phone: 734-677-6000
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Principal Investigator: Robert Riesenberg
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Bellevue, Washington 98007
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Charleston, South Carolina 29406
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Englewood, Colorado
Principal Investigator: Cori Millen
Phone: 720-336-4300
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Gent,
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Morgantown, West Virginia
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Palo Alto, California 94305
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Stephen Silberstein
Phone: 215-955-2243
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona
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Santa Monica, California 90404
Principal Investigator: David Kudrow
Phone: 310-315-1456
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