A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine

Last updated: June 19, 2020
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Pain

Pain (Pediatric)

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT03559257
16670
I5Q-MC-CGAW
2018-000600-42
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of migraine or chronic migraine.

  • History of migraine headaches at least 1 year prior to screening, with onset prior toage 50.

  • History of at least 4 migraine headache days and at, with at least 1 headache-free dayper month on average within the past 3 months.

  • Have documentation of 2 to 4 migraine preventive medication category failures due toinadequate efficacy or tolerability, in the past 10 years.

Exclusion

Exclusion Criteria:

  • Are currently enrolled in or have participated within the last 30 days or within 5half-lives (whichever is longer) in a clinical trial involving an investigationalproduct.

  • Current use or prior exposure to galcanezumab or another calcitonin gene-relatedpeptide (CGRP) antibody.

  • History of persistent daily headache, cluster headache or migraine subtypes includinghemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migrainewith brainstem aura (basilar-type migraine).

  • Pregnant or nursing.

Study Design

Total Participants: 463
Study Start date:
July 31, 2018
Estimated Completion Date:
September 19, 2019

Connect with a study center

  • Algemeen Ziekenhuis St Jan Brugge

    Brugge, 8000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, B-9000
    Belgium

    Site Not Available

  • Okanagan Clinical Trials

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • Aggarwal and Associates Ltd

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • DIEX Recherche Sherbrooke, Inc

    Sherbrooke, Quebec J1H 1Z1
    Canada

    Site Not Available

  • Clintrial, s.r.o.

    Praha 10, Hl. M. Praha 100 00
    Czechia

    Site Not Available

  • Neurologicka ambulance, Neurologie Brno s.r.o.

    Brno, 616 00
    Czechia

    Site Not Available

  • Brain-Soultherapy s.r.o

    Kladno, 27201
    Czechia

    Site Not Available

  • DADO MEDICAL, s.r.o.

    Praha 2, 120 00
    Czechia

    Site Not Available

  • Neurologicka ordinace

    Praha 6, 160 00
    Czechia

    Site Not Available

  • Institut Neuropsychiatricke Pece

    Praha 8, 18600
    Czechia

    Site Not Available

  • Aarhus Universitetshospital, Aarhus Sygehus

    Aarhus C, Jutland 8000
    Denmark

    Site Not Available

  • Glostrup Hospital

    Glostrup, 2600
    Denmark

    Site Not Available

  • CHRU de Lille- Hôpital Roger Salengro

    Lille, Cedex 59037
    France

    Site Not Available

  • Hôpital de Cimiez

    Nice, 06000
    France

    Site Not Available

  • CHU St Etienne Hopital Nord

    Saint Etienne Cedex 2, 42000
    France

    Site Not Available

  • DRK-Kliniken Nordhessen

    Kassel, Hessen 34121
    Germany

    Site Not Available

  • Praxis Dr. Philipp Stude

    Bochum, Nordrhein-Westfalen 44787
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, Thüringen 07747
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, 45147
    Germany

    Site Not Available

  • Valeomed Kft.

    Esztergom, Komarom-Esztergom 2500
    Hungary

    Site Not Available

  • Orszagos Idegtudomanyi Intezet

    Budapest, 1145
    Hungary

    Site Not Available

  • SE Neurologiai Klinika

    Budapest, 1083
    Hungary

    Site Not Available

  • Ospedale Bellaria

    Bologna, 40139
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, 50139
    Italy

    Site Not Available

  • Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico de Modena

    Modena, 41124
    Italy

    Site Not Available

  • Fondazione Istituto Neurologico Nationale C. Mondino

    Pavia, 27100
    Italy

    Site Not Available

  • IRCCS San Raffaele Pisana

    Roma, 00163
    Italy

    Site Not Available

  • Higashi Sapporo Neurology and Neurosurgery Clinic

    Sapporo, Hokkaido 003-0003
    Japan

    Site Not Available

  • Medical corporation Shinmatsudakai Atago Hospital

    Kochi-Shi, Kochi 780-0051
    Japan

    Site Not Available

  • Sendai Headache and Neurology Clinic

    Sendai, Miyagi 982-0014
    Japan

    Site Not Available

  • Takase internal medicine clinic

    Toyonaka-shi, Osaka 560-0012
    Japan

    Site Not Available

  • Dokkyo Medical University Hospital

    Shimotsuga-Gun, Tochigi 321 0293
    Japan

    Site Not Available

  • Fukuuchi Pain Clinic

    Shinjuku-ku, Tokyo 160-0017
    Japan

    Site Not Available

  • Shimoda Neurology Clinic

    Tottori-shi, Tottori 680-0045
    Japan

    Site Not Available

  • Doi Clinic Internal Medicine Neurology

    Hiroshima, 730-0031
    Japan

    Site Not Available

  • Tanaka neurosurgical clinic

    Kagoshima, 892-0844
    Japan

    Site Not Available

  • Tatsuoka Neurology Clinic

    Kyoto, 600-8811
    Japan

    Site Not Available

  • Ooba Clinic for Neurosurgery & Headache

    Oita, 870-0831
    Japan

    Site Not Available

  • Tominaga Hospital

    Osaka, 5560017
    Japan

    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.

    Ōita, 870-0831
    Japan

    Site Not Available

  • Kangbuk Samsung Hosp

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, 120-792
    Korea, Republic of

    Site Not Available

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland 6532 SZ
    Netherlands

    Site Not Available

  • Boerhaave Medisch Centrum

    Amsterdam, 1078 VV
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Isala Klinieken

    Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • Instituto de Neurologia Dra. Ivonne Fraga

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010
    Spain

    Site Not Available

  • Hull Royal Infirmary

    Hull, East Yorkshire HU3 2JZ
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Site Not Available

  • St Thomas's Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • 21st Century Neurology

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Medical Center for Clinical Research

    San Diego, California 92108
    United States

    Site Not Available

  • California Medical Clinic for Headache

    Santa Monica, California 90404
    United States

    Site Not Available

  • Sensible Healthcare

    Ocoee, Florida 34761
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Renstar Medical Research

    Wesley Chapel, Florida 33544
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Michigan Head, Pain and Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Healthy Perspectives Innovative Mental Health Services, PL

    Nashua, New Hampshire 03060
    United States

    Site Not Available

  • Bio Behavioral Health

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Site Not Available

  • PharmQuest

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Coastal Carolina Research Center, Inc.

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Foothill Family Clinic

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • Health Research of Hampton Roads Inc

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007-4209
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Seattle, Washington 98007
    United States

    Site Not Available

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