A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
CONQUER
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study
3 other identifiers
interventional
463
13 countries
69
Brief Summary
The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2018
Shorter than P25 for phase_3
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedStudy Start
First participant enrolled
July 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedResults Posted
Study results publicly available
July 8, 2020
CompletedJuly 8, 2020
October 1, 2019
11 months
June 6, 2018
June 19, 2020
June 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
Baseline, Month 1 through Month 3
Secondary Outcomes (18)
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine
Baseline, Month 1 through Month 3
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
Baseline, Month 1 through Month 3
Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
Baseline, Month 1 through Month 3
Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Baseline, Month 3
Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants With Episodic Migraine
Baseline, Month 3
- +13 more secondary outcomes
Study Arms (2)
Galcanezumab
EXPERIMENTALGalcanezumab administered subcutaneously (SC).
Placebo
PLACEBO COMPARATORPlacebo administered SC.
Interventions
Eligibility Criteria
You may qualify if:
- Have a diagnosis of migraine or chronic migraine.
- History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.
- History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.
- Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.
You may not qualify if:
- Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
- Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
- History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine).
- Pregnant or nursing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
21st Century Neurology
Phoenix, Arizona, 85004, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
University of South Florida
Tampa, Florida, 33612, United States
Renstar Medical Research
Wesley Chapel, Florida, 33544, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Healthy Perspectives Innovative Mental Health Services, PL
Nashua, New Hampshire, 03060, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
Health Research of Hampton Roads Inc
Newport News, Virginia, 23606, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209, United States
Algemeen Ziekenhuis St Jan Brugge
Bruges, 8000, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Universitair Ziekenhuis Gent
Ghent, B-9000, Belgium
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
Aggarwal and Associates Ltd
Brampton, Ontario, L6T 0G1, Canada
DIEX Recherche Sherbrooke, Inc
Sherbrooke, Quebec, J1H 1Z1, Canada
Clintrial, s.r.o.
Prague, Hl. M. Praha, 100 00, Czechia
Neurologicka ambulance, Neurologie Brno s.r.o.
Brno, 616 00, Czechia
Brain-Soultherapy s.r.o
Kladno, 27201, Czechia
DADO MEDICAL, s.r.o.
Prague, 120 00, Czechia
Neurologicka ordinace
Prague, 160 00, Czechia
Institut Neuropsychiatricke Pece
Prague, 18600, Czechia
CHRU de Lille- Hôpital Roger Salengro
Lille, Cedex, 59037, France
Hôpital de Cimiez
Nice, 06000, France
CHU St Etienne Hopital Nord
Saint-Etienne, 42000, France
DRK-Kliniken Nordhessen
Kassel, Hesse, 34121, Germany
Praxis Dr. Philipp Stude
Bochum, North Rhine-Westphalia, 44787, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Valeomed Kft.
Esztergom, Komárom-Esztergom, 2500, Hungary
SE Neurologiai Klinika
Budapest, 1083, Hungary
Orszagos Idegtudomanyi Intezet
Budapest, 1145, Hungary
Higashi Sapporo Neurology and Neurosurgery Clinic
Sapporo, Hokkaido, 003-0003, Japan
Medical corporation Shinmatsudakai Atago Hospital
Kochi, Kochi, 780-0051, Japan
Sendai Headache and Neurology Clinic
Sendai, Miyagi, 982-0014, Japan
Takase internal medicine clinic
Toyonaka-shi, Osaka, 560-0012, Japan
Dokkyo Medical University Hospital
Shimotsuga-Gun, Tochigi, 321 0293, Japan
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo, 160-0017, Japan
Shimoda Neurology Clinic
Tottori-shi, Tottori, 680-0045, Japan
Doi Clinic Internal Medicine Neurology
Hiroshima, 730-0031, Japan
Tanaka neurosurgical clinic
Kagoshima, 892-0844, Japan
Tatsuoka Neurology Clinic
Kyoto, 600-8811, Japan
Tominaga Hospital
Osaka, 5560017, Japan
Ooba Clinic for Neurosurgery & Headache
Ōita, 870-0831, Japan
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
Instituto de Neurologia Dra. Ivonne Fraga
San Juan, PR, 00918, Puerto Rico
Nowon Eulji Medical Center, Eulji University
Seoul, 01830, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hosp
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 120-792, South Korea
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marques De Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47010, Spain
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ, United Kingdom
Kings College Hospital
London, Greater London, SE5 9RS, United Kingdom
St Thomas's Hospital
London, SE1 7EH, United Kingdom
Related Publications (10)
Ford JH, Ye W, Ayer DW, Mi X, Bhandari S, Buse DC, Lipton RB. Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine. J Patient Rep Outcomes. 2023 Apr 4;7(1):34. doi: 10.1186/s41687-023-00552-4.
PMID: 37016181DERIVEDAilani J, Andrews JS, Tockhorn-Heidenreich A, Wenzel R, Rettiganti M. Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis. Adv Ther. 2022 Oct;39(10):4544-4555. doi: 10.1007/s12325-022-02233-y. Epub 2022 Aug 5.
PMID: 35930126DERIVEDAilani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.
PMID: 35076090DERIVEDTepper SJ, Ailani J, Ford JH, Nichols RM, Li LQ, Kemmer P, Hand AL, Tockhorn-Heidenreich A. Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER). Clin Drug Investig. 2022 Mar;42(3):263-275. doi: 10.1007/s40261-021-01115-5. Epub 2022 Jan 18.
PMID: 35041159DERIVEDOkonkwo R, Tockhorn-Heidenreich A, Stroud C, Paget MA, Matharu MS, Tassorelli C. Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study. J Headache Pain. 2021 Sep 30;22(1):113. doi: 10.1186/s10194-021-01322-7.
PMID: 34592919DERIVEDReuter U, Lucas C, Dolezil D, Hand AL, Port MD, Nichols RM, Stroud C, Tockhorn-Heidenreich A, Detke HC. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Adv Ther. 2021 Nov;38(11):5465-5483. doi: 10.1007/s12325-021-01911-7. Epub 2021 Sep 20.
PMID: 34542830DERIVEDCitrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.
PMID: 34264500DERIVEDKuruppu DK, Tobin J, Dong Y, Aurora SK, Yunes-Medina L, Green AL. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021 Apr 23;21(1):175. doi: 10.1186/s12883-021-02196-7.
PMID: 33892641DERIVEDSchwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021 Mar 25;22(1):15. doi: 10.1186/s10194-021-01230-w.
PMID: 33765912DERIVEDMulleners WM, Kim BK, Lainez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S, Tockhorn-Heidenreich A, Aurora SK, Nichols RM, Yunes-Medina L, Detke HC. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020 Oct;19(10):814-825. doi: 10.1016/S1474-4422(20)30279-9. Epub 2020 Sep 16.
PMID: 32949542DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
June 18, 2018
Study Start
July 31, 2018
Primary Completion
June 19, 2019
Study Completion
September 19, 2019
Last Updated
July 8, 2020
Results First Posted
July 8, 2020
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.