12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

Study Identifier
3101-301-002
CT.gov Identifier
NCT03777059
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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Plain Language Summary
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Scientific Result Summary
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Study Details

Medical Condition
  • Migraine - Episodic
    • Study Drug
  • Atogepant
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * At least a 1-year history of migraine with or without aura consistent with a diagnosis. * Age of the participant at the time of migraine onset \<50 years.
    Exclusion Criteria:
    * Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine. * Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy. * History of an inadequate response to \>4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine. * Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

    Protocol Summary

    To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.

    Study Locations

    Location
    Status
    Location
    Synexus Clinical Research US, Inc.
    Chandler, Arizona, United States, 85224
    Status
    Not applicable
    Location
    Advanced Research Associates
    Glendale, Arizona, United States, 85308
    Status
    Not applicable
    Location
    Alea Research Institute
    Phoenix, Arizona, United States, 85012
    Status
    Not applicable
    Location
    Barrow Neurological Institute
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    Orange Grove Family Practice
    Tucson, Arizona, United States, 85741
    Status
    Not applicable
    Location
    Principals Research Group
    Hot Springs, Arkansas, United States, 71901
    Status
    Not applicable
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