Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

NCT04740827 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 3101-304-0022019-003448-58
• Study Type: interventional
• Target: 315
• Locations: 15 countries
• Sites: 114

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.

Conditions

Episodic Migraine

Keywords

Episodic migraine

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population

  Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis.

  Baseline to Week 12

• Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population

  Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis.

  Baseline to Week 12

Secondary Outcomes (12)

• 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

  Baseline to Week 12

• 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

  Baseline to Week 12

• Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population

  Baseline to Week 12

• Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population

  Baseline to Week 12

• Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population

  Baseline to Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period.

Drug: Placebo

Atogepant 60 mg

ACTIVE COMPARATOR

Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.

Drug: Atogepant 60 mg

Interventions

Atogepant 60 mg DRUG

Atogepant tablets.

Atogepant 60 mg

Placebo DRUG

Atogepant matching placebo tablets.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• to 14 migraine days in the 28-day baseline period per eDiary
• Failed oral migraine prophylaxis medications from 2 to 4 medication classes

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (114)

Axiom Research /ID# 226379

Colton, California, 92324, United States

Location

Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434

Encino, California, 91316, United States

Location

Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388

Los Alamitos, California, 90720-3500, United States

Location

Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405

Los Alamitos, California, 90720-3500, United States

Location

Excell Research, Inc /ID# 228386

Oceanside, California, 92056, United States

Location

Alpine Clinical Research Center /ID# 226201

Boulder, Colorado, 80301-1880, United States

Location

Sensible Healthcare /ID# 226197

Ocoee, Florida, 34761, United States

Location

Meridien Research /ID# 226224

St. Petersburg, Florida, 33709, United States

Location

Meridien Research /ID# 226302

St. Petersburg, Florida, 33709, United States

Location

Velocity Clinical Research - Boise /ID# 226320

Meridian, Idaho, 83642, United States

Location

Allied Physicians - Fort Wayne Neurological Center /ID# 226350

Fort Wayne, Indiana, 46804, United States

Location

Deaconess Clinic - Gateway Health Center /ID# 226481

Newburgh, Indiana, 47630, United States

Location

Pharmasite Research, Inc. /ID# 226445

Baltimore, Maryland, 21208, United States

Location

StudyMetrix Research /ID# 226297

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research LLC /ID# 226273

Springfield, Missouri, 65807, United States

Location

Methodist Physicians Clinic /ID# 226470

Fremont, Nebraska, 68025, United States

Location

Amici Clinical Research - Raritan /ID# 226282

Raritan, New Jersey, 08869, United States

Location

Albuquerque Clinical Trials, Inc /ID# 233445

Albuquerque, New Mexico, 87102, United States

Location

CTI Clinical Trial and Consulting /ID# 226281

Cincinnati, Ohio, 45212, United States

Location

FutureSearch Trials of Neurology /ID# 226423

Austin, Texas, 78731, United States

Location

Austin Clinical Trial Partners /ID# 228387

Austin, Texas, 78737, United States

Location

DiscoveResearch, Inc /ID# 226491

Bryan, Texas, 77802, United States

Location

FutureSearch Trials of Dallas, LP /ID# 226493

Dallas, Texas, 75231, United States

Location

LinQ Research, LLC /ID# 226227

Pearland, Texas, 77584, United States

Location

Highland Clinical Research /ID# 226288

Salt Lake City, Utah, 84124, United States

Location

Northwest Clinical Research Center /ID# 226228

Bellevue, Washington, 98007, United States

Location

Alfred Health /ID# 226341

Melbourne, Victoria, 3004, Australia

Location

The Royal Melbourne Hospital /ID# 226402

Parkville, Victoria, 3050, Australia

Location

Aggarwal and Associates Limited /ID# 226321

Brampton, Ontario, L6T 0G1, Canada

Location

Ottawa Headache Centre Research Inc /ID# 226257

Ottawa, Ontario, K2G 6E2, Canada

Location

Diex Recherche Sherbrooke Inc. /ID# 226375

Sherbrooke, Quebec, J1L 0H8, Canada

Location

POLIKLINIKA CHOCEN, a.s. /ID# 226510

Choceň, 565 01, Czechia

Location

BRAIN-SOULTHERAPY s.r.o. /ID# 226489

Kladno, 272 01, Czechia

Location

CCR Ostrava, s.r.o. /ID# 226279

Ostrava, 702 00, Czechia

Location

A-SHINE s.r.o. /ID# 226208

Pilsen, 301 00, Czechia

Location

CLINTRIAL s.r.o. /ID# 226192

Prague, 100 00, Czechia

Location

DADO MEDICAL s.r.o. /ID# 226548

Prague, 120 00, Czechia

Location

CCR Prague s.r.o. /ID# 226214

Prague, 130 00, Czechia

Location

CCR Czech a.s /ID# 226270

Prague, 140 00, Czechia

Location

FORBELI s.r.o. /ID# 226396

Prague, 160 00, Czechia

Location

INEP medical s.r.o. /ID# 226531

Prague, 186 00, Czechia

Location

Vestra Clinics s.r.o. /ID# 226547

Rychnov nad Kněžnou, 516 01, Czechia

Location

NeuroMed Zlin s.r.o. /ID# 226487

Zlín, 760 01, Czechia

Location

Rigshospitalet Glostrup /ID# 226271

Glostrup Municipality, Capital Region, 2600, Denmark

Location

CHU Nice - Hopital de Cimiez /ID# 226401

Nice, Alpes-Maritimes, 06000, France

Location

CHU Lille /ID# 226501

Lille, Nord, 59000, France

Location

CHU de SAINT ETIENNE - Hopital Nord /ID# 226397

Saint Priest EN Jarez, Pays de la Loire Region, 42270, France

Location

CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226438

Clermont-Ferrand, 63000, France

Location

AP-HP - Hopital Lariboisière /ID# 226221

Paris, 75010, France

Location

Universitaetsklinikum Tuebingen /ID# 226529

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441

Berlin, 10117, Germany

Location

Klinische Forschung Dresden GmbH /ID# 226194

Dresden, 01069, Germany

Location

Praxis Dr. Gendolla /ID# 226497

Essen, 45133, Germany

Location

Universitaetsklinikum Essen /ID# 226527

Essen, 45147, Germany

Location

Klinische Forschung Hannover-Mitte GmbH /ID# 226195

Hanover, 30159, Germany

Location

Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439

Jena, 07747, Germany

Location

Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767

Kassel, 34131, Germany

Location

Schmerzklinik Kiel /ID# 226499

Kiel, 24149, Germany

Location

AmBeNet GmbH /ID# 226213

Leipzig, 04107, Germany

Location

Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202

Mittweida, 09648, Germany

Location

Universitaetsmedizin Rostock /ID# 226517

Rostock, 18057, Germany

Location

Neuropoint GmbH /ID# 226377

Ulm, 89073, Germany

Location

Neuropraxis Muenchen Sued /ID# 226216

Unterhaching, 82008, Germany

Location

Studienzentrum Nord-West /ID# 226360

Westerstede, 26655, Germany

Location

Intermed GmbH /ID# 226376

Wiesbaden, 65189, Germany

Location

DKD Helios Klinik Wiesbaden /ID# 226534

Wiesbaden, 65191, Germany

Location

Bugat Pal Korhaz /ID# 226357

Gyöngyös, Heves County, 3200, Hungary

Location

Valeomed Kft /ID# 226535

Esztergom, Komárom-Esztergom, 2500, Hungary

Location

Szent Borbala Korhaz /ID# 226400

Tatabánya, Komárom-Esztergom, 2800, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485

Kaposvár, Somogy County, 7400, Hungary

Location

Mind Klinika Kft. /ID# 233438

Budapest, 1024, Hungary

Location

Clinexpert Kft /ID# 226467

Budapest, 1033, Hungary

Location

Department of Neurology, University of Szeged /ID# 226442

Szeged, 6725, Hungary

Location

Ospedale Ss. Filippo e Nicola /ID# 226530

Avezzano, L Aquila, 67051, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 226361

Rome, Lazio, 00128, Italy

Location

Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475

Bologna, 40126, Italy

Location

Azienda Ospedaliero Universitaria Careggi /ID# 226502

Florence, 50134, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399

Milan, 20133, Italy

Location

AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503

Napoli, 80138, Italy

Location

Universita di Pavia /ID# 226536

Pavia, 27100, Italy

Location

Martini Ziekenhuis /ID# 226343

Groningen, 9728 NT, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis /ID# 226488

Nijmegen, 6532 SZ, Netherlands

Location

ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317

Terneuzen, 4535 PA, Netherlands

Location

Solumed Centrum Medyczne /ID# 226299

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

NZOZ Vitamed /ID# 226293

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland

Location

Specjalistyczne Gabinety Sp. z o.o. /ID# 226266

Krakow, Lesser Poland Voivodeship, 30-539, Poland

Location

Centrum Leczenia Padaczki i Migreny /ID# 226543

Krakow, Lesser Poland Voivodeship, 31-209, Poland

Location

Centrum Medyczne Oporow /ID# 226469

Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

Location

Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235

Lublin, Lublin Voivodeship, 20-582, Poland

Location

Duplicate_RCMed Oddzial Sochaczew /ID# 226369

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

Centrum Medyczne Pratia Gdynia /ID# 226437

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Silmedic Sp. z o.o. /ID# 226267

Katowice, Silesian Voivodeship, 40-282, Poland

Location

EuroMedis sp. z o.o. /ID# 226268

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

Location

Gabinet Lekarski Jacek Rozniecki /ID# 226323

Lodz, Łódź Voivodeship, 90-338, Poland

Location

Bashkir State Medical University /ID# 226552

Ufa, Bashkortostan Republic, 450005, Russia

Location

Kazan State Medical University /ID# 226498

Kazan', Tatarstan, Respublika, 420012, Russia

Location

Sbhi Cp 2 Hdm /Id# 226494

Moscow, 117556, Russia

Location

University Headache Clinic /ID# 226435

Moscow, 119221, Russia

Location

Cephalgolog /ID# 226541

Moscow, 125040, Russia

Location

Hospital Unversitario Marques de Valdecilla /ID# 226239

Santander, Cantabria, 39008, Spain

Location

University Clinical Hospital of Valladolid /ID# 226528

Valledolid, Castellon, 47005, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 226230

Barcelona, 08035, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 226550

Barcelona, 08041, Spain

Location

Hospital Clinico Universitario San Carlos /ID# 226483

Madrid, 28040, Spain

Location

Hospital Clinico Universitario de Valencia /ID# 226472

Valencia, 46010, Spain

Location

Hospital Clinico Universitario Lozano Blesa /ID# 226395

Zaragoza, 50009, Spain

Location

Karolinska university hospital, Huddinge /ID# 226215

Huddinge, Stockholm County, 141 86, Sweden

Location

Queen Elizabeth University Hospital /ID# 226492

Glasgow, G51 4TF, United Kingdom

Location

Re:Cognition Health - Guildford /ID# 226539

Guildford, GU2 7YD, United Kingdom

Location

NHS Highland /ID# 226542

Inverness, IV2 3UJ, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust /ID# 226538

Leeds, LS9 7TF, United Kingdom

Location

St Pancras Clinical Research /ID# 226551

London, EC2Y 8EA, United Kingdom

Location

King's College Hospital NHS Foundation Trust /ID# 226525

London, SE5 9RS, United Kingdom

Location

Re:Cognition Health - London /ID# 226540

London, W1G 9JF, United Kingdom

Location

Related Publications (4)

• Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.

  PMID: 39982105 DERIVED

• Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23.

  PMID: 39715475 DERIVED

• Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305.

  PMID: 39648617 DERIVED

• Tassorelli C, Nagy K, Pozo-Rosich P, Lanteri-Minet M, Sacco S, Nezadal T, Guo H, De Abreu Ferreira R, Forero G, Trugman JM. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Apr;23(4):382-392. doi: 10.1016/S1474-4422(24)00025-5. Epub 2024 Feb 13.

  PMID: 38364831 DERIVED

MeSH Terms

Interventions

atogepant

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: March 5, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

NL (3); AU (2); CZ (12); US (26); FR (5); SE (1); RU (5); PL (11); HU (7); CA (3); ES (7); GB (7); DE (17); DK (1); IT (7)