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

• Status: Active, not recruiting
• Trial end date: 2022-01-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan; Peking University Third Hospital
• Collaborator: Allergan Limited 1st Floor Marlow International, The Parkway Marlow, Buckinghamshire SL7 lYL

Criteria

Inclusion Criteria:

• At least a 1-year history of CM consistent with a diagnosis according to the 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.