A Study Of Galcanezumab In Participants With Episodic Cluster Headache
NCT ID: NCT02397473
Last Updated: 2019-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
109 participants
INTERVENTIONAL
2015-05-22
2018-06-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Galcanezumab 300mg
Galcanezumab 300mg administered subcutaneously (SC) every 30 days during an 8 week treatment period.
Galcanezumab
Administered SC
Placebo
Placebo administered SC every 30 days during an 8 week treatment period.
Placebo
Administered SC
Interventions
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Galcanezumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants are able to distinguish cluster headache attacks from other headaches.
Exclusion Criteria
* 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).
* Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford University Hospital
Palo Alto, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
St. Anthony's Hospital
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Atlanta Center of Medical Research
Atlanta, Georgia, United States
Michigan Head, Pain, and Neurological Institute
Ann Arbor, Michigan, United States
ClinVest
Springfield, Missouri, United States
Dent Neurological Institute
Amherst, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Ghent, , Belgium
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Liège, , Belgium
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Montreal, , Canada
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Toronto, , Canada
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Glostrup Municipality, , Denmark
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Helsinki, , Finland
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Jyväskylä, , Finland
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Turku, , Finland
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Lille, , France
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Nice, , France
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Paris, , France
"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
Paris, , France
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Saint-Etienne, , France
Uniklinikum Essen AöR
Essen, , Germany
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Hamburg, , Germany
Migräne- und Kopfschmerzklinik GmbH & Co. KG
Königstein, , Germany
Klinikum der Universität München Campus Großhadern
München, , Germany
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Athens, , Greece
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Athens, , Greece
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Florence, , Italy
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Milan, , Italy
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Pavia, , Italy
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Amsterdam, , Netherlands
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Nijmegen, , Netherlands
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A Coruña, , Spain
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Barcelona, , Spain
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Valencia, , Spain
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Hull, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
Countries
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References
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Jensen RH, Tassorelli C, Myers Oakes TM, Bardos JN, Zhou C, Dong Y, Aurora SK, Martinez JM. Baseline demographics and disease characteristics of patients with episodic or chronic cluster headache: data from two phase 3 randomized clinical trials in Europe and North America. Front Neurol. 2023 Dec 15;14:1293163. doi: 10.3389/fneur.2023.1293163. eCollection 2023.
Andrews JS, Kudrow D, Rettiganti M, Oakes T, Bardos JN, Wenzel R, Kuruppu DK, Gaul C, Martinez JM. Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache. J Pain Res. 2021 Jul 8;14:2059-2070. doi: 10.2147/JPR.S305066. eCollection 2021.
Goadsby PJ, Dodick DW, Leone M, Bardos JN, Oakes TM, Millen BA, Zhou C, Dowsett SA, Aurora SK, Ahn AH, Yang JY, Conley RR, Martinez JM. Trial of Galcanezumab in Prevention of Episodic Cluster Headache. N Engl J Med. 2019 Jul 11;381(2):132-141. doi: 10.1056/NEJMoa1813440.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Click here for more information about this study: A Study of LY2951742 in Participants With Episodic Cluster Headache
Other Identifiers
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I5Q-MC-CGAL
Identifier Type: OTHER
Identifier Source: secondary_id
2015-000149-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15780
Identifier Type: -
Identifier Source: org_study_id
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