Clinical trial NCT03559257: A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: prevention
prophylaxis
headache
treatment-resistant
treatment resistant
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
timeFrame: Baseline, Month 1 through Month 3
Secondary outcomes:
measure: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine
timeFrame: Baseline, Month 1 through Month 3
measure: Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
timeFrame: Baseline, Month 1 through Month 3
measure: Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days
timeFrame: Baseline, Month 1 through Month 3
measure: 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)
timeFrame: Baseline, Month 3
measure: 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
timeFrame: Baseline, Month 3
measure: Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days
timeFrame: Baseline, Month 1 through Month 3
measure: Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days
timeFrame: Baseline, Month 1 through Month 3
measure: Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days
timeFrame: Baseline, Month 1 through Month 3
measure: Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days
timeFrame: Baseline, Month 1 through Month 3
measure: Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use
timeFrame: Baseline, Month 1 through Month 3
measure: Overall Mean Change From Baseline in the Number of Monthly Headache Days
timeFrame: Baseline, Month 1 through Month 3
measure: Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4)
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US)
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK)
timeFrame: Baseline, Month 3
measure: Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 21st Century Neurology
state: Arizona
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Wesley Chapel
country: United States
facility: Renstar Medical Research
state: Florida
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head, Pain and Neurological Institute
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Nashua
country: United States
facility: Healthy Perspectives Innovative Mental Health Services, PL
state: New Hampshire
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
city: Salt Lake City
country: United States
facility: Foothill Family Clinic
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis St Jan Brugge
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal and Associates Ltd
state: Ontario
city: Sherbrooke
country: Canada
facility: DIEX Recherche Sherbrooke, Inc
state: Quebec
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
state: Hl. M. Praha
city: Brno
country: Czechia
facility: Neurologicka ambulance, Neurologie Brno s.r.o.
city: Kladno
country: Czechia
facility: Brain-Soultherapy s.r.o
city: Praha 2
country: Czechia
facility: DADO MEDICAL, s.r.o.
city: Praha 6
country: Czechia
facility: Neurologicka ordinace
city: Praha 8
country: Czechia
facility: Institut Neuropsychiatricke Pece
city: Lille
country: France
facility: CHRU de Lille- Hôpital Roger Salengro
state: Cedex
city: Nice
country: France
facility: Hôpital de Cimiez
city: Saint Etienne Cedex 2
country: France
facility: CHU St Etienne Hopital Nord
city: Kassel
country: Germany
facility: DRK-Kliniken Nordhessen
state: Hessen
city: Bochum
country: Germany
facility: Praxis Dr. Philipp Stude
state: Nordrhein-Westfalen
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Esztergom
country: Hungary
facility: Valeomed Kft.
state: Komarom-Esztergom
city: Budapest
country: Hungary
facility: SE Neurologiai Klinika
city: Budapest
country: Hungary
facility: Orszagos Idegtudomanyi Intezet
city: Sapporo
country: Japan
facility: Higashi Sapporo Neurology and Neurosurgery Clinic
state: Hokkaido
city: Kochi-Shi
country: Japan
facility: Medical corporation Shinmatsudakai Atago Hospital
state: Kochi
city: Sendai
country: Japan
facility: Sendai Headache and Neurology Clinic
state: Miyagi
city: Toyonaka-shi
country: Japan
facility: Takase internal medicine clinic
state: Osaka
city: Shimotsuga-Gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Shinjuku-ku
country: Japan
facility: Fukuuchi Pain Clinic
state: Tokyo
city: Tottori-shi
country: Japan
facility: Shimoda Neurology Clinic
state: Tottori
city: Hiroshima
country: Japan
facility: Doi Clinic Internal Medicine Neurology
city: Kagoshima
country: Japan
facility: Tanaka neurosurgical clinic
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic
city: Oita
country: Japan
facility: Ooba Clinic for Neurosurgery & Headache
city: Osaka
country: Japan
facility: Tominaga Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hosp
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: San Juan
country: Puerto Rico
facility: Instituto de Neurologia Dra. Ivonne Fraga
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques De Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: East Yorkshire
city: London
country: United Kingdom
facility: Kings College Hospital
state: Greater London
city: London
country: United Kingdom
facility: St Thomas's Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: Ailani 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.
citation: Ailani 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.
citation: Tepper 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.
citation: Okonkwo 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.
citation: Reuter 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.
citation: Citrome 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.
citation: Kuruppu 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.
citation: Schwedt 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.
citation: Mulleners 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.