A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
NCT ID: NCT02797951
Last Updated: 2022-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2016-07-13
2021-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Galcanezumab
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
Galcanezumab
Administered SC
Interventions
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Galcanezumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.
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) (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.
18 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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Mayo Clinic Hospital
Phoenix, Arizona, 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
University of South Florida
Tampa, Florida, United States
Atlanta Center of Medical Research
Atlanta, Georgia, United States
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, 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
Universitair Ziekenhuis Gent
Ghent, , Belgium
Centre Hospitalier Regional de la Citadelle
Liège, , Belgium
Stroyan Research
Toronto, Ontario, Canada
Centre de Traitement Neurologique
Montreal, , Canada
Glostrup Hospital
Glostrup Municipality, , Denmark
Suomen Terveystalo
Jyväskylä, , Finland
Terveystalo Pulssi
Turku, , Finland
CHRU de Lille - Hôpital Roger Salengro
Lille, Cedex, France
APHM Hôpital de la Timone
Marseille, , France
Hôpital de Cimiez
Nice, , France
Hopital Lariboisière
Paris, , France
CHU St Etienne Hopital Nord
Saint-Etienne, , France
Klinikum der Universität München
München, Bavaria, Germany
Migräne- und Kopfschmerzklinik GmbH & Co. KG
Königstein im Taunus, Hesse, Germany
Praxis Dr. Philipp Stude
Bochum, North Rhine-Westphalia, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Universitaetsklinikum Essen
Essen, , Germany
401 Army General Hospital of Athens
Athens, Attica, Greece
Eginition Hospital of Athens
Athens, , Greece
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Istituto Neurologico Carlo Besta
Milan, , Italy
Fondazione Istituto Neurologico Nationale C. Mondino
Pavia, , Italy
Boerhaave Medisch Centrum
Amsterdam, , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hull Royal Infirmary
Hull, East Yorkshire, United Kingdom
Walton Centre for Neurology and Neurosurgery
Liverpool, Lancashire, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
Countries
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References
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Riesenberg R, Gaul C, Stroud CE, Dong Y, Bangs ME, Wenzel R, Martinez JM, Oakes TM. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. 2022 Oct;42(11-12):1225-1235. doi: 10.1177/03331024221103509. Epub 2022 May 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Other Identifiers
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I5Q-MC-CGAR
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005234-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16351
Identifier Type: -
Identifier Source: org_study_id
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