Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine

Study Identifier
3101-106-002
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English

Study Details

Medical Condition
  • Migraine - General
  • Study Drug
  • Atogepant
  • Ubrogepant
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years

    Protocol Summary

    Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. This study will assess the drug to drug interaction between atogepant and ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in combination, in adult participants with migraine.

    Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine. Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the study in multiple sites in the United States.

    Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination. The study duration will be 30 days with a 7 day follow period.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, telephone assessments, blood tests, checking for side effects, and clinician-rated assessments.

    Study Locations

    Location
    Status
    Location
    PPD Clinical Research Unit /ID# 227676
    Orlando, Florida, United States, 32806-1044
    Status
    Not applicable
    Location
    Bio-Kinetic Clinical Applications, LLC /ID# 227675
    Springfield, Missouri, United States, 65802-4842
    Status
    Not applicable
    Location
    Spaulding Clinical Research LLC /ID# 229505
    West Bend, Wisconsin, United States, 53095
    Status
    Not applicable