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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

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

Key facts

Study ID

NCT03855137

Run by

Allergan

People needed

778

Starts

2019-03-11

Expected to finish

2022-01-20

Last updated by the study team

2023-02-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Baptist Health Center for Clinical Research /ID# 237361 — Little Rock, Arkansas, United States
• California Headache and Balance Center /ID# 236246 — Fresno, California, United States
• Wr-Pri Llc /Id# 236008 — Los Alamitos, California, United States
• Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237692 — Newport Beach, California, United States
• Schuster Medical Research Institute /ID# 236447 — Sherman Oaks, California, United States
• Alpine Clinical Research Center /ID# 234346 — Boulder, Colorado, United States
• George Washington University Medical Faculty Associates /ID# 238011 — Washington D.C., District of Columbia, United States
• Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161 — St. Petersburg, Florida, United States
• Accel Research Sites - Tampa Clinical Research Unit /ID# 237485 — Tampa, Florida, United States
• Premiere Research Institute - Palm Beach /ID# 238192 — West Palm Beach, Florida, United States
• NeuroTrials Research Inc. /ID# 237364 — Atlanta, Georgia, United States
• Josephson-Wallack-Munshower Neurology - NE /ID# 238234 — Indianapolis, Indiana, United States
• Collective Medical Research /ID# 236400 — Prairie Village, Kansas, United States
• Ochsner Clinic Foundation /ID# 236543 — Covington, Louisiana, United States
• Beth Israel Deaconess Medical Center /ID# 237540 — Boston, Massachusetts, United States
• BTC of New Bedford /ID# 236384 — New Bedford, Massachusetts, United States
• Clinical Research Institute, Inc /ID# 238299 — Minneapolis, Minnesota, United States
• Headache Neurology Research Institute /ID# 236464 — Ridgeland, Mississippi, United States
• Nevada Headache Institute /ID# 236420 — Las Vegas, Nevada, United States
• Dartmouth-Hitchcock Medical Center /ID# 237444 — Lebanon, New Hampshire, United States
• Albuquerque Clinical Trials, Inc /ID# 236853 — Albuquerque, New Mexico, United States
• Albany Medical Center Rheumatology /ID# 236540 — Albany, New York, United States
• Dent Neurosciences Research Center, Inc. /ID# 237040 — Amherst, New York, United States
• Headache Wellness Center /ID# 236431 — Greensboro, North Carolina, United States
• Barrow Neuro Institute /ID# 236776 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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