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

Recruiting in Palo Alto (17 mi)

+302 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Allergan

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 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

History of, on average, ≥ 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator

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Treatment Details

Interventions

Atogepant 30 mg (Calcitonin Gene-Related Peptide (CGRP) Antagonist)
Atogepant 60 mg (Calcitonin Gene-Related Peptide (CGRP) Antagonist)
Placebo (Calcitonin Gene-Related Peptide (CGRP) Antagonist)

Participant Groups

3Treatment groups

Active Control

Placebo Group

Group I: Atogepant 30 mg BIDActive Control2 Interventions

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.

Group II: Atogepant 60 mg QDActive Control2 Interventions

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.

Group III: PlaceboPlacebo Group1 Intervention

Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.