Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: Standard of Care (SOC) Migraine Preventive Medication; Atogepant
Intervention description: Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.; Atogepant tablets taken orally, once daily for 52 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 744.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate safety and tolerability of treatment with atogepant for the
      prevention of episodic migraine over the course of one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and participant privacy information (e.g., written
             authorization for use and release of health and research study information) obtained
             from the participant prior to initiation of any study-specific procedures.

          -  Participant is a candidate to be prescribed at least one of the protocol-defined
             acceptable oral SOC migraine prevention medications and the participant is willing to
             accept SOC treatment.

          -  Participants must be using a medically acceptable and effective method of birth
             control during the course of the entire study,

          -  At least a 1-year history of migraine with or without aura consistent with a diagnosis

          -  Age of the participant at the time of migraine onset < 50 years

          -  History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

        Exclusion Criteria:

          -  Difficulty distinguishing migraine headaches from tension-type or other headaches

          -  Has a history of migraine accompanied by diplopia or decreased level of consciousness
             or retinal migraine

          -  Has a current diagnosis of chronic migraine (CM), new persistent daily headache,
             trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy

          -  ≥ 15 headache days per month on average across the 3 months prior to Visit 1

          -  Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month,
             or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs),
             acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's
             judgment, or during the baseline period. For all participants, barbiturates are
             excluded 30 days prior to screening and during the baseline period. For participants
             randomized to atogepant, barbiturates are excluded through the duration of the study
             as well

          -  Female participant 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

          -  Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic,
             gastrointestinal (GI), or neurologic disease

          -  Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of
             mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign
             measurements that exceed these limits may be repeated only once.

          -  At Visit 1, a user of recreational or illicit drugs or has had a history within the
             past year of drug or alcohol abuse or dependence

          -  History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes,
             inflammatory bowel disease) that may affect the absorption or metabolism of atogepant;
             participants with prior gastric bariatric interventions (e.g., Lap Band) which have
             been reversed are not excluded.