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
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant
Intervention description: Oral Tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Migraine; Migraine; Atogepant; AGN-241689

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible participants completed the double-blind treatment period, and the safety
             follow-up period, if applicable, depending on the timing of study initiation, of Study
             3101-303-002 without significant protocol deviations and who did not experience an
             adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable
             safety risk.

        Exclusion Criteria:

          -  Participants requiring any medication, diet, or nonpharmacological treatment on the
             list of prohibited concomitant medications or treatments, that cannot be discontinued
             or switched to an allowable alternative. Concomitant medications with demonstrated
             efficacy for the prevention of migraine is exclusionary, except that participants from
             lead-in study 3101-303-002 taking 1 medication with demonstrated efficacy for the
             prevention of migraine may participate in the current study provided that the dose was
             stable prior to the lead-in study and the participant is willing to continue taking
             that medication.

          -  Participants with an electrocardiogram (ECG) indicating clinically significant
             abnormalities at Visit 1.

          -  Participants with hypertension (sitting systolic blood pressure (BP) > 160 mm Hg or
             sitting diastolic BP > 100 mm Hg) at Visit 1.

          -  Participants with a significant risk of self-harm Columbia-Suicide Severity Rating
             Scale (C-SSRS), or of harm to others (investigator opinion); participants who report
             suicidal ideation with intent, with or without a plan, since the last visit, must be
             excluded.

          -  Participants with clinically significant hematologic, endocrine, cardiovascular,
             pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.