Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

NCT06806293 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: M24-8592024-512946-41-00
• Study Type: interventional
• Target: 468
• Locations: 13 countries
• Sites: 95

Brief Summary

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often throbbing or pulsating. The headache is often accompanied by sensitivity to light, sensitivity to sound, nausea, or other symptoms. Menstrual migraine (MM) attacks are migraine attacks that occur in individuals before or during their menstrual period. The main goals of the study are to evaluate the efficacy (how well the medicine works), safety, and tolerability (the degree to which any adverse symptoms can be handled by the patients during the study) of atogepant, compared to placebo (looks like the study treatment but has no medicine in it), for the prevention of MM. Atogepant is an investigational drug being developed for the preventive treatment of menstrual migraine. Participants are randomly assigned to one of the 2 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 2 chance for the participant to receive placebo. 468 adult female participants with menstrual migraine are enrolled in approximately 92 sites across the world. Participants will receive oral atogepant or matching placebo for 3 menstrual cycles during the double-blind period. During the open-label treatment period, participants will receive atogepant during each menstrual cycle. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Conditions

Menstrual Migraine (MM)

Keywords

Menstrual Migraine; Atogepant; QULIPTA; AQUIPTA

Outcome Measures

Primary Outcomes (1)

• Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP) Averaged Across 3 Menstrual Cycles During the Double-Blind Period

  A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

  Up to approximately 120 days

Secondary Outcomes (8)

• Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

  Up to approximately 120 days

• Change in Number of Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

  Up to approximately 120 days

• Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs During the Double-Blind Period

  Up to approximately 120 days

• Change in Number of Acute Medication Use Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

  Up to approximately 120 days

• Change in Number of Moderate or Severe Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

  Up to approximately 120 days

Study Arms (2)

Atogepant

EXPERIMENTAL

Participant will receive atogepant during Double-Blind period and Open-Label period.

Drug: Atogepant

Placebo for Atogepant

PLACEBO COMPARATOR

Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.

Drug: Atogepant; Drug: Placebo for Atogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: Qulipta, Aquipta

Atogepant; Placebo for Atogepant

Placebo for Atogepant DRUG

Oral Tablet

Placebo for Atogepant

Eligibility Criteria

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

You may qualify if:

• History and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses).
• History of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) for \>= 12 months prior to Visit 1/Screening.
• Migraine onset before age 50 years.
• By history at Visit 1/Screening, participant meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day -2 to Day +3 relative to menses onset) in the opinion of the investigator.
• Participant records 3 perimenstrual periods (PMP) in the eDiary during the screening period, and in at least 2 of 3 PMPs the participant experiences and records a migraine attack in the eDiary with at least 1 migraine day.

You may not qualify if:

• History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by International Classification of Headache Disorders, 3rd Edition (ICHD-3).
• An average of 15 or more headache days per month recorded in the eDiary during the screening period.
• History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
• Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3.
• Required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening.
• Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment.
• Has a condition or situation, which the investigator feels will compromise the safety of the participant or the quality of the data and renders the subject an unsuitable candidate for the study.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (95)

Premier Health - Centerville /ID# 267023

Centerville, Ohio, 45459, United States

Location

Chinese PLA General Hospital /ID# 267141

Beijing, Beijing Municipality, 100039, China

Location

Nanfang Hospital - Southern Medical University /ID# 268510

Guangzhou, Guangdong, 510000, China

Location

Hebei General Hospital /ID# 267663

Shijiazhuang, Hebei, 500051, China

Location

Renmin Hospital of Wuhan University /ID# 267671

Wuhan, Hubei, 430060, China

Location

The First Affiliated Hospital of Soochow University /ID# 267885

Suzhou, Jiangsu, 215006, China

Location

Shaanxi Provincial PeopleS Hospital /ID# 267827

Xi'an, Shaanxi, 710054, China

Location

First Affiliated Hospital of Shanxi Medical University /ID# 267680

Taiyuan, Shanxi, 030001, China

Location

Tianjin Medical University General Hospital /ID# 268846

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin People's Hospital /ID# 268511

Tianjin, Tianjin Municipality, 300120, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994

Hangzhou, Zhejiang, 310009, China

Location

Minksneuro /ID# 267651

Brno, Brno-mesto, 603 00, Czechia

Location

A-Shine s.r.o. /ID# 266048

Pilsen, Plzeň Region, 301 00, Czechia

Location

Vseobecna Fakultni nemocnice v Praze /ID# 268100

Prague, Praha 17, 128 00, Czechia

Location

DADO MEDICAL s.r.o. /ID# 267629

Prague, Praha 2, 120 00, Czechia

Location

Neurologie Brno /ID# 266050

Brno, 616 00, Czechia

Location

NeuroHK s.r.o. /ID# 266051

Hradec Králové, 500 09, Czechia

Location

Neuro plus s.r.o. /ID# 266052

Olomouc, 775 00, Czechia

Location

Clintrial s.r.o. /ID# 266047

Prague, 100 00, Czechia

Location

Pratia Prague s.r.o. /ID# 268252

Prague, 130 00, Czechia

Location

Fakultni Thomayerova nemocnice /ID# 266049

Prague, 140 59, Czechia

Location

Neuro Centrum Odenwald - Praxis Erbach /ID# 276171

Erbach im Odenwald, Hesse, 64711, Germany

Location

Studienzentrum Nord-West /ID# 267311

Westerstede, Lower Saxony, 26655, Germany

Location

Universitaetsmedizin Greifswald /ID# 267277

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

Location

Neurozentrum Bielefeld /ID# 276170

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

Klinikum Ibbenbueren /ID# 267393

Ibbenbueren, North Rhine-Westphalia, 49477, Germany

Location

ZNS Siegen /ID# 268247

Siegen, North Rhine-Westphalia, 57076, Germany

Location

Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285

Chemnitz, Saxony, 09111, Germany

Location

Ambenet Hausarztpraxis /ID# 267309

Leipzig, Saxony, 04107, Germany

Location

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267310

Berlin, 10117, Germany

Location

MIND Clinic /ID# 267652

Budapest, 1024, Hungary

Location

Cortex Study Center /ID# 266639

Budapest, 1026, Hungary

Location

Clinexpert Kft /ID# 266644

Budapest, 1033, Hungary

Location

Semmelweis Egyetem /ID# 266636

Budapest, 1085, Hungary

Location

Semmelweis Egyetem /ID# 266752

Budapest, 1085, Hungary

Location

UNO Medical Trials /ID# 266643

Budapest, 1135, Hungary

Location

S-Medicon Kft /ID# 266637

Budapest, 1138, Hungary

Location

Uzsoki Utcai Kórház /ID# 266641

Budapest, 1145, Hungary

Location

Azienda Ospedaliero Universitaria Careggi /ID# 276163

Florence, Firenze, 50134, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 267062

Milan, Milano, 20133, Italy

Location

Istituto Auxologico Italiano - Ospedale San Luca /ID# 276161

Milan, Milano, 20149, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 266859

Rome, Roma, 00168, Italy

Location

ICOT Istituto Marco Pasquali /ID# 267288

Latina, 04100, Italy

Location

Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 267922

Pavia, 27100, Italy

Location

Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 267926

Perugia, 06156, Italy

Location

ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 267019

Udine, 33100, Italy

Location

Konan Medical Center /ID# 266867

Kobe, Hyōgo, 658-0064, Japan

Location

Fujitsu Clinic /ID# 266877

Kawasaki-shi, Kanagawa, 211-8588, Japan

Location

Umenotsuji Clinic /ID# 266834

Kochi, Kochi, 780-8011, Japan

Location

Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864

Sendai, Miyagi, 982-0014, Japan

Location

Ooba Clinic For Neurosurgery & Headache /ID# 266866

Ōita, Oita Prefecture, 870-0831, Japan

Location

Chibune General Hospital /ID# 266874

Osaka, Osaka, 555-0034, Japan

Location

Tominaga Clinic - Osaka /ID# 268228

Osaka, Osaka, 556-0015, Japan

Location

Usuda Clinic Of Internal Medicine /ID# 266870

Setagaya-ku, Tokyo, 156-0043, Japan

Location

Tokyo Headache Clinic /ID# 266863

Shibuya-ku, Tokyo, 151-0051, Japan

Location

Nagaseki Headache Clinic /ID# 266865

Kai, Yamanashi, 400-0124, Japan

Location

Solumed Centrum Medyczne /ID# 267220

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

Athleticomed Sp. z o.o /ID# 266434

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland

Location

SPZOZ Szpital Uniwersytecki w Krakowie /ID# 266443

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

Penta Hospitals Badania Kliniczne /ID# 266732

Wroclaw, Lower Silesian Voivodeship, 54-429, Poland

Location

Novo-Med Zielinski i wspolnicy SP. J. /ID# 266433

Katowice, Silesian Voivodeship, 40-584, Poland

Location

Neuro-Care Sp. z o.o. sp.k /ID# 267883

Katowice, Silesian Voivodeship, 40-749, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 266437

Wroclaw, 52-210, Poland

Location

Unidade Local de Saude do Alto Ave, EPE /ID# 266168

Guimarães, Braga District, 4835-044, Portugal

Location

Hospital da Luz /ID# 266182

Lisbon, Lisbon District, 1500-650, Portugal

Location

Unidade Local de Saude de Loures-Odivelas /ID# 266190

Loures, Lisbon District, 2674-514, Portugal

Location

Unidade Local de Saude de Matosinhos EPE /ID# 266170

Senhora da Hora, Porto District, 4464-513, Portugal

Location

Unidade Local de Saude de Almada-Seixal, EPE /ID# 276215

Almada, Setúbal District, 2805-267, Portugal

Location

Unidade Local de Saude da Regiao de Aveiro, EPE /ID# 266187

Aveiro, 3814-501, Portugal

Location

2CA-Braga, Hospital de Braga /ID# 276218

Braga, 4710-243, Portugal

Location

Unidade Local de Saude de Santa Maria /ID# 275932

Lisbon, 1649-035, Portugal

Location

Unidade Local de Saude Sao Joao /ID# 266185

Porto, 4200-319, Portugal

Location

Unidade Local de Saude da Arrabida, EPE /ID# 266183

Setúbal, 2910-446, Portugal

Location

Hallym University Dongtan Sacred Heart Hospital /ID# 267473

Hwaseong, Gyeonggido, 18450, South Korea

Location

Nowon Eulji Medical Center, Eulji University /ID# 267474

Seoul, Seoul Teugbyeolsi, 01830, South Korea

Location

Seoul National University Hospital /ID# 267477

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Kangbuk Samsung Hospital /ID# 267475

Seoul, Seoul Teugbyeolsi, 03181, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 267476

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Hospital Universitari Vall d Hebron /ID# 276467

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona /ID# 276468

Barcelona, 08036, Spain

Location

Hospital Clinico San Carlos /ID# 275896

Madrid, 28040, Spain

Location

Hospital Universitario La Paz /ID# 276332

Madrid, 28046, Spain

Location

Hospital Clinico Universitario de Valladolid /ID# 275899

Valladolid, 47003, Spain

Location

China Medical University Hospital /ID# 266423

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital /ID# 267754

Tainan, 704, Taiwan

Location

Mackay Memorial Hospital /ID# 266421

Taipei, 104, Taiwan

Location

Taipei Veterans General Hospital /ID# 266418

Taipei, 112, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 266424

Taoyuan City, 333, Taiwan

Location

The Adam Practice - Upton Cross /ID# 268116

Poole, Dorset, BH16 5PW, United Kingdom

Location

Royal Sussex County Hospital /ID# 268362

Brighton, East Sussex, BN2 5BE, United Kingdom

Location

St Pancras Clinical Research - London /ID# 268653

London, Greater London, EC2Y 8EA, United Kingdom

Location

Guy's Hospital /ID# 267587

London, Greater London, SE1 9RT, United Kingdom

Location

Breckland Alliance /ID# 268772

Thetford, Norfolk, IP24 1JD, United Kingdom

Location

Oxford University Hospitals - John Radcliffe Hospital /ID# 267659

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Interventions

atogepant

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: February 10, 2025
• Primary Completion: June 29, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

HU (8); CZ (10); GB (6); IT (8); PL (8); TW (5); CN (10); DE (9); ES (5); JP (10); PT (10); KR (5); US (1)