Study to Assess Adverse Events (AEs) When Oral Atogepant Tablet is Given to Adult Chinese Participants Who Completed Study 3101-303-002 to Prevent Chronic Migraine

Study Identifier
3101-311-002
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Chinese (Simplified)

Study Details

Medical Condition
  • Migraine - Chronic
  • Study Drug
  • Atogepant
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years

    Protocol Summary

    Migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The main objective of the study is to evaluate how safe and effective the atogepant is in preventing chronic migraine in adult Chinese participants who completed study 3101-303-002. Adverse events will be monitored.

    Atogepant is an investigational drug being developed to prevent chronic migraine. All participants will receive the same treatment. Approximately 120 adult participants who completed study 3101-303-002 will be enrolled at approximately 25 centers in China.

    All participants will receive atogepant oral tablet once daily for 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
    Chinese PLA General Hospital /ID# 227546
    Beijing, Beijing Municipality, China, 100853
    Status
    Not applicable
    Location
    The Second Hospital of Shanxi Medical University /ID# 227567
    Taiyuan, Shanxi, China, 030000
    Status
    Not applicable
    Location
    The second Affiliated hospital of Zhejiang University school of Medicine /ID# 227558
    Hangzhou, Zhejiang, China, 310009
    Status
    Not applicable