A Study Of Galcanezumab In Participants With Episodic Cluster Headache

Last updated: August 26, 2019
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Chronic Pain

Migraine (Pediatric)

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT02397473
15780
I5Q-MC-CGAL
2015-000149-22
  • Ages 18-65
  • All Genders

Study Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of cluster headache as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines witha history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1month.

  • Participants are able to distinguish cluster headache attacks from other headaches.

Exclusion

Exclusion Criteria:

  • Current enrollment in or discontinuation within the last 30 days from, a clinicaltrial involving any investigational drug or device.

  • 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 trigeminalautonomic cephalalgia.

  • A history of migraine variants that could implicate or could be confused withischemia.

  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeuticproteins.

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

  • Evidence of significant active or unstable psychiatric disease, in the opinion of theinvestigator.

  • Women who are pregnant or nursing.

Study Design

Total Participants: 109
Study Start date:
May 22, 2015
Estimated Completion Date:
June 04, 2018

Connect with a study center

  • 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.

    Gent, 9000
    Belgium

    Site Not Available

  • 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.

    Liege, 4000
    Belgium

    Site Not Available

  • 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.

    Hamilton, L8N IY2
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Montreal, H2L 4M1
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Ottawa, K2G 6E2
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Toronto, M4S IY2
    Canada

    Site Not Available

  • 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.

    Glostrup, 2600
    Denmark

    Site Not Available

  • 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.

    Helsinki, 00930
    Finland

    Site Not Available

  • 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.

    Jyvaskyla, 40100
    Finland

    Site Not Available

  • 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.

    Jyväskylä, 40100
    Finland

    Site Not Available

  • 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.

    Turku, 20100
    Finland

    Site Not Available

  • 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.

    Lille, 59037
    France

    Site Not Available

  • 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.

    Nice, 06003
    France

    Site Not Available

  • "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, 75475
    France

    Site Not Available

  • 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.

    Paris, 75010
    France

    Site Not Available

  • 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.

    Saint Etienne Cedex 2, 42055
    France

    Site Not Available

  • Uniklinikum Essen AöR

    Essen, 45147
    Germany

    Site Not Available

  • 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.

    Hamburg, 20246
    Germany

    Site Not Available

  • Migräne- und Kopfschmerzklinik GmbH & Co. KG

    Konigstein, 61462
    Germany

    Site Not Available

  • Klinikum der Universität München Campus Großhadern

    Munchen, 81377
    Germany

    Site Not Available

  • 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.

    Athens, 11525
    Greece

    Site Not Available

  • 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.

    Firenze, 50134
    Italy

    Site Not Available

  • 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.

    Milano, 20133
    Italy

    Site Not Available

  • 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.

    Pavia, 27100
    Italy

    Site Not Available

  • 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.

    Amsterdam, 1078 VV
    Netherlands

    Site Not Available

  • 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.

    Nijmegen, 6532 SZ
    Netherlands

    Site Not Available

  • 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.

    Barcelona, 08035
    Spain

    Site Not Available

  • 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.

    La Coruna, 15706
    Spain

    Site Not Available

  • 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.

    Valencia, 46010
    Spain

    Site Not Available

  • 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.

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • 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.

    Liverpool, L9 7LJ
    United Kingdom

    Site Not Available

  • 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.

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford University Hospital

    Palo Alto, California 94304
    United States

    Site Not Available

  • California Medical Clinic for Headache

    Santa Monica, California 90404
    United States

    Site Not Available

  • Colorado Neurological Institute

    Englewood, Colorado 80113
    United States

    Site Not Available

  • New England Institute for Clinical Research

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Florida Center for Headache and Sports Neurology

    Port St. Lucie, Florida 34952
    United States

    Site Not Available

  • St. Anthony's Hospital

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • St Anthonys Hospital

    St. Petersburg, Florida 33705
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Atlanta Center of Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Robbins Headache Clinic

    Riverwoods, Illinois 60015
    United States

    Site Not Available

  • New England Regional Headache Center

    Worcester, Massachusetts 01601
    United States

    Site Not Available

  • Michigan Head, Pain, and Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota 55422
    United States

    Site Not Available

  • Mercy Health Reseach

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • ClinVest

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Mercy Health Reseach

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Renown Institute for Neurosciences

    Reno, Nevada 89502
    United States

    Site Not Available

  • Dent Neurological Institute

    Amherst, New York 14226
    United States

    Site Not Available

  • Island Neurological Associates

    Plainview, New York 11803
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Clinical Trials of South Carolina

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007-4209
    United States

    Site Not Available

  • West Virginia University Hospital

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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