A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments (DELIVER)

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Eptinezumab

Detailed Description

The total study duration from the screening visit to the completion visit is approximately 76 weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24 weeks) and a treatment extension period (48 weeks).

The participant will start treatment at the baseline visit and follow a 12-week dosing schedule with either eptinezumab (100 or 300 milligrams [mg]) or placebo by intraveneous (IV) infusion. Participants who were assigned to placebo in the placebo-controlled treatment period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or eptinezumab 100 mg.

• Study Type: Interventional
• Enrollment (Actual): 892
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-Capitale
    • Brussels, Bruxelles-Capitale, Belgium, 1090
      • Universitair Ziekenhuis Brussel
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis - Campus Virga Jesse
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Universitair Ziekenhuis Gent
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8000
      • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
• Bulgaria
  • Pleven, Bulgaria, 5804
    • Multiprofile Hospital for Active Treatment Heart and Brain EAD
  • Ruse, Bulgaria, 7012
    • Medical Center - Teodora EOOD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital
  • Veliko Tarnovo, Bulgaria, 5006
    • Medical Center Medica Plus
  • Sofia City
    • Sofia, Sofia City, Bulgaria, 1113
      • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
    • Sofia, Sofia City, Bulgaria, 1142
      • First Multiprofile Hospital for Active Treatment - Sofia
• Czechia
  • Jihlava, Czechia, 586 01
    • Nemocnice Jihlava
  • Litomyshl, Czechia, 57001
    • Neurosanatio s.r.o
  • Slezska Ostrava, Czechia, 710 00
    • Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon
  • Zlín, Czechia, 760 01
    • NeuroMed Zlín s.r.o.
  • Hradec Kralové
    • Hradec Kralove, Hradec Kralové, Czechia, 500 03
      • MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance
    • Rychnov nad Kneznou, Hradec Kralové, Czechia, 516 01
      • Vestra Clinics
  • Jihormoravsky Kraj
    • Brno, Jihormoravsky Kraj, Czechia, 602 00
      • CCR Brno
  • Moravian-Silesian
    • Ostrava-Poruba-Poruba, Moravian-Silesian, Czechia, 708 52
      • Fakultni nemocnice Ostrava
  • Prague
    • Praha 4, Prague, Czechia, 140 59
      • Fakultni Thomayerova nemocnice
    • Praha 6, Prague, Czechia, 160 00
      • Neurologická Ambulance - Forbeli
    • Praha 6, Prague, Czechia, 160 00
      • Neuropsychiatrie s.r.o.
    • Praha 8, Prague, Czechia, 186 00
      • Institut Neuropsychiatricke pece
  • Praha
    • Praha 3, Praha, Czechia, 130 00
      • CCR Prague
  • Severomoravsky Kraj
    • Ostrava, Severomoravsky Kraj, Czechia, 702 00
      • CCR Ostrava
  • South Moravian
    • Brno, South Moravian, Czechia, 656 91
      • Fakultni Nemocnice u sv. Anny v Brne
• Denmark
  • Esbjerg, Denmark, 6700
    • Sydvestjysk sygehus - Esbjerg
  • Hovedstaden
    • Glostrup, Hovedstaden, Denmark, 2600
      • Rigshospitalet Glostrup
  • Syddanmark
    • Odense, Syddanmark, Denmark, 5000
      • Odense Universitetshospital
• Finland
  • Kuopio, Finland, 70210
    • Itä-Suomen Yliopisto - Kuopion Kampus
  • Tampere, Finland, 33100
    • Terveystalo Tampere
  • Länsi-Suomen Lääni
    • Tampere, Länsi-Suomen Lääni, Finland, 33520
      • Tampereen yliopistollinen sairaala
  • Southern Finland
    • Helsinki, Southern Finland, Finland, 00180
      • Terveystalo Ruoholahti
  • Western Finland
    • Turku, Western Finland, Finland, 20100
      • Terveystalo Turku Pulssi
• France
  • Côte-d'Or
    • Nice Cedex 1, Côte-d'Or, France, 91179 - 06003
      • Hôpital Cimiez
  • Haute-Normandie
    • Rouen, Haute-Normandie, France, 76000
      • Hôpital Charles-Nicolle
  • Nord
    • Lille Cedex, Nord, France, 59037
      • Hôpital Roger Salengro
  • Pays De La Loire
    • Angers, Pays De La Loire, France, 49 933
      • Centre Hosptitalier Universitaire d'Angers
  • Provence Alpes Cote D'Azure
    • Marseille cedex 5, Provence Alpes Cote D'Azure, France, 13 354
      • Assistance Publique Hopitaux de Marseille
  • Rhone-Alps
    • Bron, Rhone-Alps, France, 69500
      • Hôpital Pierre Wertheimer
• Georgia
  • Tbilisi, Georgia, 0167
    • Jerarsi Clinic
  • Tbilisi, Georgia, 0114
    • Pineo Medical Ecosystem
  • Tbilisi, Georgia, 0159
    • Archangel Saint Michael Multiprofile Clinical Hospital
  • Tbilisi, Georgia, 0160
    • Aversi Clinic - Central Branch
  • Tbilisi, Georgia, 0160
    • Mediclub Georgia Medical
  • Tbilisi, Georgia, 0172
    • Malkhaz Katsiashvili Multiprofile Emergency Center
  • Tbilisi, Georgia, 0179
    • Simon Khechinashvili University Hospital
  • Tbilisi, Georgia, 0186
    • Consilium Medulla Multiprofile Clinic
  • Tbilisi
    • T'bilisi, Tbilisi, Georgia, 0112
      • Helsicore - Israeli-Georgian Medical Research Clinic
    • T'bilisi, Tbilisi, Georgia, 0112
      • LLC Todua Clinic
• Germany
  • Berlin, Germany, 12627
    • Synexus Clinical Research - Berlin
  • Unterhaching, Germany, 82008
    • Neuropraxis München Süd
  • Baden-Wuerttemberg
    • Ostfildern, Baden-Wuerttemberg, Germany, 73760
      • MVZ Dr. Roth & Kollegen GbR
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68163
      • Neuroplus
    • Stuttgart, Baden-Württemberg, Germany, 70182
      • NeuroConcept AG
  • Bayern
    • Nürnberg, Bayern, Germany, 90402
      • Praxis Dr. Steinwachs
  • Hamburg (Hansestadt)
    • Hamburg, Hamburg (Hansestadt), Germany, 20251
      • CTC North
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60313
      • Synexus - Prüfzentrum Frankfurt/Main
  • Hessen
    • Königstein Im Taunus, Hessen, Germany, 61462
      • Migräne- und Kopfschmerzklinik Königstein
  • Niedersachsen
    • Westerstede, Niedersachsen, Germany, 26655
      • Studienzentrum Nord West
  • Nordrhein-Westfalen
    • Bielefeld, Nordrhein-Westfalen, Germany, 33647
      • Neurozentrum Bielefeld
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • Neurologische Praxis Dr. Stude
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitätsklinikum Essen
    • Essen, Nordrhein-Westfalen, Germany, 45133
      • Praxis Astrid Gendolla
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Synexus - Leipzig
• Hungary
  • Budapest, Hungary, 1152
    • UNO Medical Trials Kft.
  • Komarom-Esztergom County
    • Esztergom, Komarom-Esztergom County, Hungary, 2500
      • VALEOMED Diagnosztikai Központ
  • Pest
    • Kistarcsa, Pest, Hungary, 2143
      • Pest Megyei Flor Ferenc Korhaz
• Italy
  • Bologna, Italy, 40139
    • IRCCS Istituto delle Scienze Neurologiche di Bologna
  • Florence, Italy, 50139
    • Azienda Ospedaliero - Universitaria Careggi
  • Pavia, Italy, 27100
    • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
  • Roma
    • Rome, Roma, Italy, 00163
      • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
  • Rome
    • Roma, Rome, Italy, 00128
      • Università Campus Bio-Medico di Roma
    • Roma, Rome, Italy, 00189
      • Azienda Ospedaliera - Universitaria Sant' Andrea
• Poland
  • Czestochowa, Poland, 42-200
    • Centrum Medyczne Pratia - Czestochowa
  • Lodz, Poland, 90-368
    • SOMED CR - Lodz
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 52-416
      • Centrum Medyczne OPOROW
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
      • Centrum Medyczne Pratia - Bydgoszcz
  • Lubelskie
    • Lublin, Lubelskie, Poland, 20-093
      • Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
    • Lublin, Lubelskie, Poland, 20-582
      • Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-510
      • Pratia McM Kraków
    • Krakow, Malopolskie, Poland, 30-539
      • Specjalistyczne Gabinety Sp. z o.o.
    • Oswiecim, Malopolskie, Poland, 32-600
      • Instytut Zdrowia Dr Boczarska-Jedynak
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-773
      • Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz
    • Warszawa, Mazowieckie, Poland, 01-737
      • SOMED CR - Warsaw
    • Warszawa, Mazowieckie, Poland, 01-868
      • MTZ Clinical Research powered by Pratia
  • Pomorskie
    • Gdynia, Pomorskie, Poland, 81-537
      • Synexus - Gdynia
  • Silesia
    • Siemianowice Slaskie, Silesia, Poland, 41-100
      • Neuro-Care Katowice
  • Slaskie
    • Czestochowa, Slaskie, Poland, 42-202
      • Synexus - Częstochowa
    • Katowice, Slaskie, Poland, 40-040
      • Synexus - Katowice
  • Warminsko-Mazurskie
    • Elblag, Warminsko-Mazurskie, Poland, 82-300
      • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-529
      • Centrum Medyczne Solumed
    • Poznan, Wielkopolskie, Poland, 60-702
      • Synexus - Poznań
• Russian Federation
  • Moscow, Russian Federation, 121467
    • University Headache Clinic
• Slovakia
  • Banska Bystrica, Slovakia, 97404
    • Neurologicka ambulancia MUDr. Dupejova s.r.o.
  • Bardejov, Slovakia, 8501
    • In Medic
  • Dolny Kubin, Slovakia, 026 01
    • MEDBAJ s.r.o.
  • Dubnica nad Vahom, Slovakia, 01841
    • Medicínske Centrum Konzílium - Dubnica nad Vahom
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen Del Rocio
  • Valladolid, Spain, 47003
    • Hospital Clínico Universitario de Valladolid
  • València, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa
  • Biscay
    • Bilbao, Biscay, Spain, 48013
      • Hospital Universitario de Basurto
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Hospital Universitario Quironsalud Madrid
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36213
      • Hospital Alvaro Cunqueiro - Clinico Universitario Vigo
• Sweden
  • Kronoborgs Län
    • Värnamo, Kronoborgs Län, Sweden, 331 50
      • Migränkliniken Europa AB
  • Skåne Län
    • Helsingborg, Skåne Län, Sweden, 25220
      • Stortorgets neurologmottagning
    • Kristianstad, Skåne Län, Sweden, 291 85
      • Centralsjukhuset Kristianstad
  • Östergötlands Län
    • Linkoeping, Östergötlands Län, Sweden, 581 85
      • Universitetssjukhuset i Linköping
• United Kingdom
  • England
    • Bellshill, England, United Kingdom, ML4 3NJ
      • Synexus - Scotland Clinical Research Centre
    • Chorley, England, United Kingdom, PR7 7NA
      • Synexus - The Lancashire Clinic
    • Edgbaston, England, United Kingdom, B15 2SQ
      • Synexus Midlands Clinical Research Centre
    • Hexham, England, United Kingdom, NE46 1QJ
      • Synexus - The Hexham Clinic
    • Liverpool, England, United Kingdom, L22 0LG
      • Synexus - Merseyside Clinical Research Centre
    • London, England, United Kingdom, EN3 4GS
      • Panthera Biopartners - North London
    • Manchester, England, United Kingdom, M15 6SE
      • Synexus - Manchester Clinical Research Centre
    • Manchester, England, United Kingdom, OL11 4AU
      • Panthera Biopartners - Manchester
    • Preston, England, United Kingdom, PR2 9QB
      • Panthera Biopartners - Preston
    • Reading, England, United Kingdom, RG2 0TG
      • Synexus - Thames Valley Clinical Research Centre
    • Salford, England, United Kingdom, M6 8HD
      • Northern Care Alliance NHS Foundation Trust
  • Wales
    • Cardiff, Wales, United Kingdom, CF15 9SS
      • Synexus - Wales
• United States
  • California
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials - Gainesville
    • Maitland, Florida, United States, 32751
      • Accel Research Sites - Maitland
  • Michigan
    • Ann Arbor, Michigan, United States, 48104-5131
      • Michigan Headache and Neurological Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute Inc. - Minneapolis
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuqerque Clinical Trials
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute - Amherst
    • Brooklyn, New York, United States, 11229
      • Integrative Clinical Trials
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute - Oklahoma City
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions - Memphis
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center (NWCRC)
    • Spokane, Washington, United States, 99202
      • Northwest Neurological

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
• The participant has a migraine onset of ≤50 years of age.
• The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
• The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
• For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
• For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
• The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
• The participant has a history of either previous or active use of triptans for migraine.

Exclusion Criteria:

• The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
• The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
• The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
• The participant has a diagnosis of acute or active temporomandibular disorder.
• The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
• The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
• The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other in- and exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.	Drug: Placebo; concentrate for solution for infusion, intravenously
Experimental: Eptinezumab 100 mg; Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.	Drug: Eptinezumab; Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)
Experimental: Eptinezumab 300 mg; Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.	Drug: Eptinezumab; Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline, Weeks 1 - 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline to Weeks 1 - 12
Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline, Weeks 13 - 24
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline to Weeks 1 - 12
Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12	The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).	Baseline, Week 12
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline to Weeks 13 - 24
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline to Weeks 13 - 24
Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline to Weeks 1 - 12
Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12	A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).	Baseline to Weeks 1 - 12
Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12	A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).	Baseline to Weeks 1 - 12
Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12	A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).	Baseline to Weeks 1 - 12
Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12	A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).	Baseline, Weeks 1 - 12
Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12	A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).	Baseline, Weeks 1 - 12
Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12	A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).	Baseline, Weeks 1 - 12
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12	In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.	Baseline, Weeks 1 - 12
Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24	In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.	Baseline, Weeks 13- 24
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12	Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".	Baseline, Weeks 1 - 12
Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24	Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".	Baseline, Weeks 13 - 24
Patient Global Impression of Change (PGIC) Score at Week 12	The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.	Week 12
PGIC Score at Week 24	The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.	Week 24
Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12		Baseline, Weeks 1 - 12
Percentage of Participants With Migraine on the Day After First Dosing		Day 1
Most Bothersome Symptom (MBS) Score at Week 12	Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.	Week 12
Change From Baseline in the HIT-6 Score at Week 24	The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).	Baseline, Week 24
Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12	The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.	Baseline, Week 12
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12	The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline, Week 12
Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24	The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.	Baseline, Week 24
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24	The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline, Week 24
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12	The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.	Baseline, Week 12
Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24	The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.	Baseline, Week 24
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score	The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).	Baseline to Week 12
Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score	The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).	Baseline to Week 24
Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner	Number of participants who visited to a family doctor/general practitioner has been reported.	Week 12
HCRU: Visits to a Specialist	Number of participants who visited to a specialist has been reported.	Week 12
HCRU: Number of Emergency Department Visits Due to Your Migraine	Number of participants who visited to emergency department due to your migraine has been reported.	Week 12
HCRU: Number of Hospital Admissions Due to Migraine	Number of participants who admitted in the hospital due to migraine has been reported.	Week 12
HCRU: Total Number of Overnight Hospital Stays Due to Migraine	Number of participants who had total number of overnight hospital stays due to migraine has been reported.	Week 12
Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72	A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.	Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72	The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).	Baseline, Weeks 36, 48, 60, and 72

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Publications and helpful links

General Publications

• Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 18898A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No