Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

Last updated: September 12, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

4

Condition

Migraine (Pediatric)

Oral Facial Pain

Migraine (Adult)

Treatment

Ubrogepant

Atogepant

Clinical Study ID

NCT05264129
M23-072
  • Ages 18-80
  • All Genders

Study Summary

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine.

Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of migraine. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States.

Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks.

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 effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 1-year history of migraine with or without aura consistent with a diagnosisaccording to the International Classification of Headache Disorders (ICHD)-3, 2018.

  • History of 4 to 14 migraine days per month on average in the 3 months prior toScreening (Visit 1) in the investigator's judgment.

Exclusion

Exclusion Criteria:

  • Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular,pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Study Design

Total Participants: 263
Treatment Group(s): 2
Primary Treatment: Ubrogepant
Phase: 4
Study Start date:
March 07, 2022
Estimated Completion Date:
April 04, 2023

Connect with a study center

  • Achieve Clinical Research, LLC /ID# 244912

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Xenoscience, Inc /ID# 243506

    Phoenix, Arizona 85004
    United States

    Site Not Available

  • Excell Research, Inc /ID# 242590

    Oceanside, California 92056
    United States

    Site Not Available

  • Neurological Research Institute /ID# 244161

    Santa Monica, California 90404
    United States

    Site Not Available

  • George J. Rederich M.D. Inc. /ID# 242589

    Torrance, California 90505
    United States

    Site Not Available

  • Diablo Clinical Research /ID# 242592

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Westside Center for Clinical Research /ID# 243287

    Jacksonville, Florida 32205-4785
    United States

    Site Not Available

  • Suncoast Clinical Research /ID# 242463

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Renstar Medical Research /ID# 243672

    Ocala, Florida 34470
    United States

    Site Not Available

  • Meridien Research /ID# 243508

    Orlando, Florida 32810
    United States

    Site Not Available

  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091

    Saint Petersburg, Florida 33709-3113
    United States

    Site Not Available

  • Meridian Clinical Research (Neurology) - Savannah /ID# 242689

    Savannah, Georgia 31406-2758
    United States

    Site Not Available

  • Clinical Research Atlanta - Headlands LLC /ID# 242661

    Stockbridge, Georgia 30281-9054
    United States

    Site Not Available

  • Allied Physicians - Fort Wayne Neurological Center /ID# 243511

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Pharmasite Research, Inc. /ID# 243505

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Medstar Georgetown Neurology /ID# 243289

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • QUEST Research Institute /ID# 243284

    Farmington Hills, Michigan 48334-2977
    United States

    Site Not Available

  • Clinvest Research LLC /ID# 242597

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Princeton Center for Clinical Research /ID# 242652

    Skillman, New Jersey 08558
    United States

    Site Not Available

  • Bio Behavioral Health, Inc /ID# 242643

    Toms River, New Jersey 08755-6434
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc. /ID# 242641

    Amherst, New York 14226
    United States

    Site Not Available

  • Central New York Clinical Research /ID# 242593

    Manlius, New York 13104
    United States

    Site Not Available

  • Rochester Clinical Research /ID# 242470

    New York, New York 14609
    United States

    Site Not Available

  • North Suffolk Neurology /ID# 244163

    Port Jefferson Station, New York 11776-3387
    United States

    Site Not Available

  • PMG Research of Charlotte /ID# 242588

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • PMG Research of Raleigh LLC /ID# 243286

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • CTI Clinical Trial and Consulting /ID# 242884

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Aventiv Research Columbus /ID# 242462

    Columbus, Ohio 43213
    United States

    Site Not Available

  • The Orthopedic Foundation /ID# 243292

    New Albany, Ohio 43054-8167
    United States

    Site Not Available

  • Summit Research Network /ID# 242467

    Portland, Oregon 97210
    United States

    Site Not Available

  • Abington Neurological Associates - Abington /ID# 243291

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • WR-ClinSearch /ID# 242640

    Chattanooga, Tennessee 37421-1605
    United States

    Site Not Available

  • FutureSearch Trials of Neurology /ID# 242690

    Austin, Texas 78731
    United States

    Site Not Available

  • DiscoveResearch, Inc /ID# 242469

    Bryan, Texas 77802
    United States

    Site Not Available

  • FutureSearch Trials of Dallas, LP /ID# 242658

    Dallas, Texas 75231
    United States

    Site Not Available

  • Centex Studies, Inc. - Houston /ID# 242587

    Houston, Texas 77058
    United States

    Site Not Available

  • Protenium Clinical Research /ID# 244067

    Hurst, Texas 76054
    United States

    Site Not Available

  • ClinPoint Trials /ID# 242660

    Waxahachie, Texas 75165-1430
    United States

    Site Not Available

  • Advanced Research Institute - Ridgeline /ID# 242662

    Ogden, Utah 84405-6779
    United States

    Site Not Available

  • Highland Clinical Research /ID# 245159

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Core Clinical Research /ID# 244436

    Everett, Washington 98201
    United States

    Site Not Available

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