Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

Study Identifier
3101-303-002
CT.gov Identifier
NCT03855137
EudraCT Identifier
2018-004337-32
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
Available Language(s): English, Japanese, Czech, Korean, Polish, Russian
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Study Details

Medical Condition
  • Migraine - Chronic
    • Study Drug
  • Atogepant 30 mg
  • Atogepant 60 mg
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018 * Age of the participant at the time of migraine onset \< 50 years * Confirmation of headache/migraine headache day frequency as follows: * History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND * \>=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND * \>=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary * Participants must be using a medically acceptable and effective method of birth control during the course of the entire study
    Exclusion Criteria:
    * Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine * Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, 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 * Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.

    Protocol Summary

    This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

    Study Locations

    Location
    Status
    Location
    Barrow Neuro Institute /ID# 236776
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable
    Location
    Baptist Health Center for Clinical Research /ID# 237361
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    California Headache and Balance Center /ID# 236246
    Fresno, California, United States, 93720
    Status
    Not applicable
    Location
    Wr-Pri Llc /Id# 236008
    Los Alamitos, California, United States, 90720
    Status
    Not applicable
    Location
    Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692
    Newport Beach, California, United States, 92660
    Status
    Not applicable
    Location
    Schuster Medical Research Institute /ID# 236447
    Sherman Oaks, California, United States, 91403
    Status
    Not applicable
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