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



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:3/22/2019
Start Date:March 11, 2019
End Date:January 22, 2021
Contact:Clinical Trials Registry Team
Email:IR-CTRegistration@allergan.com
Phone:877-277-8566

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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

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


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:

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

2. ≥ 15 headache days during the 4-week screening/baseline period per the electronic
diary (eDiary) AND

3. ≥ 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.
We found this trial at
27
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Minneapolis, Minnesota 55402
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Albany, New York 12208
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Amherst, New York 14226
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Bellevue, Washington 98007
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Covington, Louisiana 70433
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Dallas, Texas 75214
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Fresno, California 93723
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Greensboro, North Carolina 27405
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Las Vegas, Nevada 89113
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Little Rock, Arkansas 72205
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McLean, Virginia 22101
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Phoenix, Arizona 85013
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Pittsburgh, Pennsylvania 15243
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Raleigh, North Carolina 27607
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Ridgeland, Mississippi 39157
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Salt Lake City, UT
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Sherman Oaks, California 91403
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Tacoma, Washington 98409
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Victoria, British Columbia
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Virginia Beach, Virginia 23456
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Washington, District of Columbia 20037
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West Palm Beach, Florida 33407
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Willow Grove, Pennsylvania 19090
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