A Study of Galcanezumab in Participants With Chronic Cluster Headache
NCT ID: NCT02438826
Last Updated: 2020-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2015-06-18
2019-08-14
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 300 mg
Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
Galcanezumab 300 mg
Administered SC
Placebo
Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months.
Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
Galcanezumab 300 mg
Administered SC
Placebo
Administered SC
Interventions
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Galcanezumab 300 mg
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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Mayo Clinic Hospital
Phoenix, Arizona, United States
California Medical Clinic for Headache
Santa Monica, California, United States
Stanford University Hospital
Stanford, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Southwestern Medical Center - Dallas
Dallas, Texas, 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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Montreal, , Canada
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Toronto, , Canada
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Glostrup Municipality, , Denmark
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Glostrup Municipality, , Denmark
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Helsinki, , Finland
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Turku, , Finland
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Lille, , France
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Marseille, , France
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Nice, , France
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Paris, , France
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Paris, , France
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Saint-Etienne, , France
Praxis Dr. Stude
Bochum, , Germany
Universtitätsklinikum Essen AöR
Essen, , Germany
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Hamburg, , Germany
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Jena, , 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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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
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Stoke-on-Trent, , 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.
Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of LY2951742 in Participants With Chronic Cluster Headache
Other Identifiers
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I5Q-MC-CGAM
Identifier Type: OTHER
Identifier Source: secondary_id
2014-005429-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15781
Identifier Type: -
Identifier Source: org_study_id
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