Clinical trial NCT04740827: Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: Episodic migraine
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.


Eligibility criteria: Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
* Age of the participant at the time of migraine onset \< 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
* 4 to 14 migraine days in the 28-day baseline period per eDiary
* Failed oral migraine prophylaxis medications from 2 to 4 medication classes

Exclusion Criteria:

* Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
* Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
* In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
* Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
* Has ≥ 15 headache days in the 28-day baseline period per eDiary
* Clinically significant cardiovascular or cerebrovascular disease
* Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
* Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018

Primary outcomes:
measure: Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population
timeFrame: Baseline to Week 12
measure: Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population
timeFrame: Baseline to Week 12
measure: Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population
timeFrame: Baseline to Week 12
measure: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug until 30 days after last dose of study drug (up to Week 12)
Other outcomes:
Locations:
city: Colton
country: United States
facility: Axiom Research /ID# 226379
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 228386
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center /ID# 226201
state: Colorado
city: Ocoee
country: United States
facility: Sensible Healthcare /ID# 226197
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research /ID# 226224
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research /ID# 226302
state: Florida
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise /ID# 226320
state: Idaho
city: Fort Wayne
country: United States
facility: Allied Physicians - Fort Wayne Neurological Center /ID# 226350
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic - Gateway Health Center /ID# 226481
state: Indiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc. /ID# 226445
state: Maryland
city: Saint Peters
country: United States
facility: StudyMetrix Research /ID# 226297
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 226273
state: Missouri
city: Fremont
country: United States
facility: Methodist Physicians Clinic /ID# 226470
state: Nebraska
city: Raritan
country: United States
facility: Amici Clinical Research - Raritan /ID# 226282
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc /ID# 233445
state: New Mexico
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting /ID# 226281
state: Ohio
city: Austin
country: United States
facility: FutureSearch Trials of Neurology /ID# 226423
state: Texas
city: Austin
country: United States
facility: Austin Clinical Trial Partners /ID# 228387
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc /ID# 226491
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP /ID# 226493
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC /ID# 226227
state: Texas
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 226288
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center /ID# 226228
state: Washington
city: Melbourne
country: Australia
facility: Alfred Health /ID# 226341
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 226402
state: Victoria
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited /ID# 226321
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Headache Centre Research Inc /ID# 226257
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc. /ID# 226375
state: Quebec
city: Chocen
country: Czechia
facility: POLIKLINIKA CHOCEN, a.s. /ID# 226510
city: Kladno
country: Czechia
facility: BRAIN-SOULTHERAPY s.r.o. /ID# 226489
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o. /ID# 226279
city: Plzen
country: Czechia
facility: A-SHINE s.r.o. /ID# 226208
city: Prague 10
country: Czechia
facility: CLINTRIAL s.r.o. /ID# 226192
city: Prague 4
country: Czechia
facility: CCR Czech a.s /ID# 226270
city: Prague
country: Czechia
facility: FORBELI s.r.o. /ID# 226396
city: Praha
country: Czechia
facility: DADO MEDICAL s.r.o. /ID# 226548
city: Praha
country: Czechia
facility: CCR Prague s.r.o. /ID# 226214
city: Praha
country: Czechia
facility: INEP medical s.r.o. /ID# 226531
city: Rychnov nad Kneznou
country: Czechia
facility: Vestra Clinics s.r.o. /ID# 226547
city: Zlin
country: Czechia
facility: NeuroMed Zlin s.r.o. /ID# 226487
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup /ID# 226271
state: Hovedstaden
city: Nice
country: France
facility: CHU Nice - Hopital de Cimiez /ID# 226401
state: Alpes-Maritimes
city: St. Priest En Jarez
country: France
facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 226397
state: Loire
city: Lille
country: France
facility: CHU Lille /ID# 226501
state: Nord
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226438
city: Paris
country: France
facility: AP-HP - Hopital Lariboisière /ID# 226221
city: Tubingen
country: Germany
facility: Universitaetsklinikum Tuebingen /ID# 226529
state: Baden-Wuerttemberg
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH /ID# 226194
city: Essen
country: Germany
facility: Praxis Dr. Gendolla /ID# 226497
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 226527
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH /ID# 226195
city: Jena
country: Germany
facility: Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439
city: Kassel
country: Germany
facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767
city: Kiel
country: Germany
facility: Schmerzklinik Kiel /ID# 226499
city: Leipzig
country: Germany
facility: AmBeNet GmbH /ID# 226213
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock /ID# 226517
city: Ulm
country: Germany
facility: Neuropoint GmbH /ID# 226377
city: Unterhaching
country: Germany
facility: Neuropraxis Muenchen Sued /ID# 226216
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West /ID# 226360
city: Wiesbaden
country: Germany
facility: Intermed GmbH /ID# 226376
city: Wiesbaden
country: Germany
facility: DKD Helios Klinik Wiesbaden /ID# 226534
city: Gyöngyös
country: Hungary
facility: Bugat Pal Korhaz /ID# 226357
state: Heves
city: Esztergom
country: Hungary
facility: Valeomed Kft /ID# 226535
state: Komarom-Esztergom
city: Tatabanya
country: Hungary
facility: Szent Borbala Korhaz /ID# 226400
state: Komarom-Esztergom
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485
state: Somogy
city: Budapest
country: Hungary
facility: Mind Klinika Kft. /ID# 233438
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 226467
city: Szeged
country: Hungary
facility: Department of Neurology, University of Szeged /ID# 226442
city: Avezzano
country: Italy
facility: Ospedale Ss. Filippo e Nicola /ID# 226530
state: L Aquila
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 226361
state: Lazio
city: Bologna
country: Italy
facility: Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi /ID# 226502
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399
city: Napoli
country: Italy
facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503
city: Pavia
country: Italy
facility: Universita di Pavia /ID# 226536
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis /ID# 226343
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis /ID# 226488
city: Terneuzen
country: Netherlands
facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow /ID# 226469
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed /ID# 226293
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Gabinet Lekarski Jacek Rozniecki /ID# 226323
state: Lodzkie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235
state: Lubelskie
city: Krakow
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 226266
state: Malopolskie
city: Krakow
country: Poland
facility: Centrum Leczenia Padaczki i Migreny /ID# 226543
state: Malopolskie
city: Sochaczew
country: Poland
facility: Duplicate_RCMed Oddzial Sochaczew /ID# 226369
state: Mazowieckie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia /ID# 226437
state: Pomorskie
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o. /ID# 226267
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne /ID# 226299
state: Wielkopolskie
city: Szczecin
country: Poland
facility: EuroMedis sp. z o.o. /ID# 226268
state: Zachodniopomorskie
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University /ID# 226552
state: Bashkortostan, Respublika
city: Kazan
country: Russian Federation
facility: Kazan State Medical University /ID# 226498
state: Tatarstan, Respublika
city: Moscow
country: Russian Federation
facility: Sbhi Cp 2 Hdm /Id# 226494
city: Moscow
country: Russian Federation
facility: University Headache Clinic /ID# 226435
city: Moscow
country: Russian Federation
facility: Cephalgolog /ID# 226541
city: Santander
country: Spain
facility: Hospital Unversitario Marques de Valdecilla /ID# 226239
state: Cantabria
city: Valledolid
country: Spain
facility: University Clinical Hospital of Valladolid /ID# 226528
state: Castellon
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 226230
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 226550
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 226483
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 226472
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa /ID# 226395
city: Huddinge
country: Sweden
facility: Karolinska university hospital, Huddinge /ID# 226215
state: Stockholms Lan
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital /ID# 226492
city: Guildford
country: United Kingdom
facility: Re:Cognition Health - Guildford /ID# 226539
city: Inverness
country: United Kingdom
facility: NHS Highland /ID# 226542
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust /ID# 226538
city: London
country: United Kingdom
facility: St Pancras Clinical Research /ID# 226551
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 226525
city: London
country: United Kingdom
facility: Re:Cognition Health - London /ID# 226540
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: