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

Study Identifier
M23-072
CT.gov Identifier
NCT05264129
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
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Study Details

Medical Condition
  • Migraine - Episodic
    • Study Drug
  • Atogepant
  • Ubrogepant
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * At least 1-year history of migraine with or without aura consistent with a diagnosis according 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 to Screening (Visit 1) in the investigator's judgment.
    Exclusion Criteria:
    \- Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Achieve Clinical Research, LLC /ID# 244912
    Birmingham, Alabama, United States, 35216
    Status
    Not applicable
    Location
    Xenoscience, Inc /ID# 243506
    Phoenix, Arizona, United States, 85004
    Status
    Not applicable
    Location
    Excell Research, Inc /ID# 242590
    Oceanside, California, United States, 92056
    Status
    Not applicable
    Location
    Neurological Research Institute /ID# 244161
    Santa Monica, California, United States, 90404
    Status
    Not applicable
    Location
    George J. Rederich M.D. Inc. /ID# 242589
    Torrance, California, United States, 90505
    Status
    Not applicable
    Location
    Diablo Clinical Research /ID# 242592
    Walnut Creek, California, United States, 94598
    Status
    Not applicable
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