Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks

Study Identifier
P25-590
CT.gov Identifier
NCT07310290
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Migraine - General
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 --a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study * Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication * Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3
    Exclusion Criteria:
    * Currently participating in a concurrent clinical or non-interventional study. * Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor. * Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3

    Protocol Summary

    Migraine is a neurological disease characterized by moderate or severe headaches, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess changes in migraine attack severity for adult participants treating with oral ubrogepant across migraine attacks.

    Ubrogepant is a drug that is approved for the acute treatment of migraine in adults. Approximately 189 participants will be enrolled in approximately 15 sites across the US.

    Participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 13 weeks.

    There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

    Study Locations

    Location
    Status
    Location
    Neurology and Pain Specialty Center /ID# 278508
    Aliso Viejo, California, United States, 92656
    Status
    Recruiting
    Location
    Chicago Headache Center & Research Inst /ID# 272345
    Naperville, Illinois, United States, 60563
    Status
    Recruiting
    Location
    Tri City Research Center, LLC /ID# 278800
    Grand Island, Nebraska, United States, 68803
    Status
    Recruiting