Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

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

  • Chronic Migraine

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