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Purpose

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018 - Age of the participant at the time of migraine onset < 50 years - Confirmation of headache/migraine headache day frequency as follows: - History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND - >=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND - >=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary - Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion Criteria

  • Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine - Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy - History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine - Woman 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 at Visit 1 and Visit 2.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.
  • Drug: Placebo
    30 mg/60 mg tablets containing atogepant-matching placebo
Active Comparator
Atogepant 30 mg BID 		Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.
  • Drug: Atogepant 30 mg
    Tablets containing 30 mg atogepant
  • Drug: Placebo
    30 mg/60 mg tablets containing atogepant-matching placebo
Active Comparator
Atogepant 60 mg QD 		Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.
  • Drug: Atogepant 60 mg
    Tablets containing 60 mg atogepant
  • Drug: Placebo
    30 mg/60 mg tablets containing atogepant-matching placebo

More Details

Status
Completed
Sponsor
Allergan

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.