A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:6 - 17
Updated:2/21/2019
Start Date:March 14, 2018
End Date:November 30, 2022
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD Study

The main purpose of this study is to determine the safety and efficacy of the study drug
galcanezumab in participants 6 to 17 years of age with episodic migraine.


Inclusion Criteria:

- Have a diagnosis of migraine as defined by the International Headache Society
International Classification of Headache Disorders (IHS ICHD-3) beta guidelines (1.1
or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 6 months prior
to screening.

Exclusion Criteria:

- Participants who are taking, or are expected to take, therapeutic antibodies during
the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.).
Prior use of therapeutic antibodies, other than antibodies to calcitonin gene-related
peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior
to baseline.

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

- Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor
antibody, including those who have previously completed or withdrawn from this study
or any other study investigating a CGRP antibody.

- History of persistent daily headache, cluster headache or migraine subtypes including
hemiplegic (sporadic or familial) migraine and migraine with brainstem aura
(previously basilar-type migraine) as defined by IHS ICHD-3 beta.

- History of any type of headache except for migraine, tension type headache, or
medication overuse headache, as defined by IHS ICHD-3 beta, in the 3 months prior to
randomization. For example, a history of post-traumatic headache in this 3-month
period would not be allowed.

- History of traumatic head injury, associated with significant change in the quality or
frequency of their headaches, including new onset of migraine following traumatic head
injury.

- Participants with a known history of intracranial tumors or developmental
malformations including Chiari malformations.
We found this trial at
16
sites
Amherst, New York 14226
Principal Investigator: Jennifer Williams McVige
Phone: 7162502000
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Marielle Kabbouche-Samaha
Phone: 513-636-4222
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Eric Remster
Phone: 214-867-6906
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Christina L Szperka
Phone: 215-590-1419
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Kavita Kalidas
Phone: 321-331-6768
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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5673 Ptree Dun Rd NE # 440
Atlanta, Georgia 30342
Principal Investigator: Frank Berenson
Phone: 678-705-7341
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Bellevue, Washington 98007
Principal Investigator: Arifulla Khan
Phone: 425-453-0404
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Caguas, 00727
Principal Investigator: Karen Cruz
Phone: 7877463136
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1555 North Barrington Road
Hoffman Estates, Illinois 60169
Principal Investigator: Hossam AbdelSalam
Phone: 847-593-8553
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Jacksonville, Florida 32216
Principal Investigator: Nandita M Jones
Phone: 904-281-5757
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Minneapolis, Minnesota 55402
Principal Investigator: Gary D. Berman
Phone: 612-333-2200
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Ocoee, Florida 34761
Principal Investigator: Kelly Taylor
Phone: 407-654-2724
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Orlando, Florida 32801
Principal Investigator: Linda S Harper
Phone: 407-425-5100
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Pittsburgh, Pennsylvania 15243
Principal Investigator: Nathan L Bennett
Phone: 412-650-6155
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San Diego, California 92108
Principal Investigator: Dane M. Shipp
Phone: 619-521-2830
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West Palm Beach, Florida 33407
Principal Investigator: Paul K Winner
Phone: 561-845-0500
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