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

Last updated: March 25, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Premenstrual Syndrome

Oral Facial Pain

Migraine (Adult)

Treatment

Placebo for Atogepant

Atogepant

Clinical Study ID

NCT06806293
M24-859
2024-512946-41
  • Ages > 18
  • Female

Study 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. Approximately 430 adult female participants with menstrual migraine will be enrolled in approximately 85 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History and eDiary confirmation have regular menstrual cycles within the range of 21to 35 days in length (Note: menstrual cycle length is calculated as onset of mensesuntil the day before the next onset of menses).

  • History of migraine (with or without aura) according to the InternationalClassification of Headache Disorders, 3rd Edition (ICHD-3) for >= 12 months prior toVisit 1/Screening.

  • Migraine onset before age 50 years.

  • By history at Visit 1/Screening, participant meets ICHD-3 criteria for puremenstrual migraine with or without aura, or menstrually-related migraine with orwithout aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacksstarting during the PMP (Day -2 to Day +3 relative to menses onset) in the opinionof the investigator.

  • Participant records 3 perimenstrual periods (PMP) in the eDiary during the screeningperiod, and in at least 2 of 3 PMPs the participant experiences and records amigraine attack in the eDiary with at least 1 migraine day.

Exclusion

Exclusion Criteria:

  • History of an average of 15 or more headache days per month during the 3 monthsprior to Visit 1/Screening per the investigator's judgment, or a current diagnosisof chronic migraine as defined by International Classification of HeadacheDisorders, 3rd Edition (ICHD-3).

  • An average of 15 or more headache days per month recorded in the eDiary during thescreening period.

  • History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine asdefined 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 timeswithin 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 perinvestigator judgment.

  • Has a condition or situation, which the investigator feels will compromise thesafety of the participant or the quality of the data and renders the subject anunsuitable candidate for the study.

Study Design

Total Participants: 430
Treatment Group(s): 2
Primary Treatment: Placebo for Atogepant
Phase: 3
Study Start date:
February 10, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Chinese PLA General Hospital /ID# 267141

    Beijing, Beijing 100039
    China

    Active - Recruiting

  • Hebei General Hospital /ID# 267663

    Shijiazhuang, Hebei 500051
    China

    Active - Recruiting

  • Pratia Prague s.r.o. /ID# 268252

    Prague, 130 00
    Czechia

    Active - Recruiting

  • ZNS Siegen /ID# 268247

    Siegen, Nordrhein-Westfalen 57076
    Germany

    Active - Recruiting

  • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285

    Chemnitz, Sachsen 09111
    Germany

    Active - Recruiting

  • Ambenet Hausarztpraxis /ID# 267309

    Leipzig, Sachsen 04107
    Germany

    Active - Recruiting

  • S-Medicon Kft /ID# 266637

    Budapest, 1138
    Hungary

    Active - Recruiting

  • ICOT Istituto Marco Pasquali /ID# 267288

    Latina, 04100
    Italy

    Active - Recruiting

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

    Pavia, 27100
    Italy

    Active - Recruiting

  • Konan Medical Center /ID# 266867

    Kobe-shi, Hyogo 658-0064
    Japan

    Active - Recruiting

  • Fujitsu Clinic /ID# 266877

    Kawasaki-shi, Kanagawa 211-8588
    Japan

    Active - Recruiting

  • Umenotsuji Clinic /ID# 266834

    Kochi-shi, Kochi 780-8011
    Japan

    Active - Recruiting

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864

    Sendai-shi, Miyagi 982-0014
    Japan

    Active - Recruiting

  • Ooba Clinic for Neurosurgery & Headache /ID# 266866

    Oita-shi, Oita 870-0831
    Japan

    Active - Recruiting

  • Chibune General Hospital /ID# 266874

    Osaka-shi, Osaka 555-0034
    Japan

    Active - Recruiting

  • Tominaga Clinic /ID# 268228

    Osaka-shi, Osaka 556-0015
    Japan

    Active - Recruiting

  • Usuda Clinic Of Internal Medicine /ID# 266870

    Setagaya-ku, Tokyo 156-0043
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic /ID# 266863

    Shibuya-ku, Tokyo 151-0051
    Japan

    Active - Recruiting

  • Nagaseki Headache Clinic /ID# 266865

    Kai, Yamanashi 400-0124
    Japan

    Active - Recruiting

  • Athleticomed Sp. z o.o /ID# 266434

    Bydgoszcz, Kujawsko-pomorskie 85-752
    Poland

    Active - Recruiting

  • Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073

    Oświęcim, Malopolskie 32-600
    Poland

    Active - Recruiting

  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 266732

    Gdansk, Pomorskie 80-546
    Poland

    Active - Recruiting

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

    Katowice, Slaskie 40-584
    Poland

    Active - Recruiting

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

    Wroclaw, 52-210
    Poland

    Active - Recruiting

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

    Guimaraes, Braga 4835-044
    Portugal

    Active - Recruiting

  • Hospital da Luz /ID# 266182

    Lisbon, Lisboa 1500-650
    Portugal

    Active - Recruiting

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

    Aveiro, 3814-501
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Sao Joao, EPE /ID# 266185

    Porto, 4202-451
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Matosinhos, EPE /ID# 266170

    Senhora da Hora, 4464-513
    Portugal

    Active - Recruiting

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

    Setubal, 2910-446
    Portugal

    Active - Recruiting

  • China Medical University Hospital /ID# 266423

    Taichung, 404
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital /ID# 267754

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital /ID# 266421

    Taipei City, 104
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital /ID# 266418

    Taipei City, 112
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 266424

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • St Pancras Clinical Research /ID# 268653

    London, Greater London EC2Y 8EA
    United Kingdom

    Active - Recruiting

  • The Adam Practice /ID# 268116

    Poole, BH16 5PW
    United Kingdom

    Active - Recruiting

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