Status:
COMPLETED
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Lead Sponsor:
Allergan
Conditions:
Chronic Migraine
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
778 Patients enrolled
Trial Details
Trial ID
NCT03855137
Start Date
March 11 2019
End Date
January 20 2022
Last Update
February 14 2023
Active Locations (150)
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1
Barrow Neuro Institute /ID# 236776
Phoenix, Arizona, United States, 85013
2
Baptist Health Center for Clinical Research /ID# 237361
Little Rock, Arkansas, United States, 72205
3
California Headache and Balance Center /ID# 236246
Fresno, California, United States, 93720
4
Wr-Pri Llc /Id# 236008
Los Alamitos, California, United States, 90720