To Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine



Status:Active, not recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:3/27/2019
Start Date:October 8, 2018
End Date:November 9, 2020

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine.

Safety and tolerability of treatment with atogepant for the prevention of episodic migraine
over the course of one year


Inclusion Criteria:

- Written informed consent and participant privacy information (eg, written
authorization for use and release of health and research study information) obtained
from the participant prior to initiation of any study-specific procedures.

- Participant is a candidate to be prescribed at least one of the protocol-defined
acceptable oral SOC (Standard of Care) migraine prevention medications and the
participant is willing to accept SOC (Standard of Care) treatment.

- Participants must be using a medically acceptable and effective method of birth
control during the course of the entire study,

- At least a 1-year history of migraine with or without aura consistent with a diagnosis

- Age of the participant at the time of migraine onset < 50 years

- History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Exclusion Criteria:

- Difficulty distinguishing migraine headaches from tension-type or other headaches

- Has a history of migraine accompanied by diplopia or decreased level of consciousness
or retinal migraine

- Has a current diagnosis of CM, new persistent daily headache, trigeminal autonomic
cephalgia (eg, cluster headache), or painful cranial neuropathy

- ≥ 15 headache days per month on average across the 3 months prior to Visit 1

- Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month,
or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month in the 3
months prior to Visit 1 per investigator's judgment, or during the baseline period.
For all participants, barbiturates are excluded 30 days prior to screening and during
the baseline period. For participants randomized to atogepant, barbiturates are
excluded through the duration of the study as well

- Female participant 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

- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, GI, or
neurologic disease

- Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP >
100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may
be repeated only once.

- At Visit 1, a user of recreational or illicit drugs or has had a history within the
past year of drug or alcohol abuse or dependence

- History of any GI prior procedures or GI conditions (eg, diarrhea syndromes,
inflammatory bowel disease) that may affect the absorption or metabolism of atogepant;
participants with prior gastric bariatric interventions (eg, Lap Band) which have been
reversed are not excluded.
We found this trial at
112
sites
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
17
mi
from 91732
Anaheim, CA
Click here to add this to my saved trials
2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
1787
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
1100 Lake Hearn Dr
Atlanta, Georgia 30342
404-255-6005
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
2319
mi
from 91732
Hallandale Beach, FL
Click here to add this to my saved trials
2417 Marshall Ave.
Imperial, California 92251
760-355-0176
165
mi
from 91732
Imperial, CA
Click here to add this to my saved trials
7000 SW 62 Ave.
Miami, Florida 33143
305-284-8483
2318
mi
from 91732
Miami, FL
Click here to add this to my saved trials
400 Gresham Dr
Norfolk, Virginia 23507
757-627-7446
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
8122 Datapoint Drive
San Antonio, Texas 78229
210-614-7483
1182
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
2302
mi
from 91732
West Palm Beach, FL
Click here to add this to my saved trials
Akron, Ohio 44311
?
mi
from 91732
Akron, OH
Click here to add this to my saved trials
Albuquerque, New Mexico
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
Allentown, Pennsylvania 18104
2353
mi
from 91732
Allentown, PA
Click here to add this to my saved trials
Amherst, New York 14226
2185
mi
from 91732
Amherst, NY
Click here to add this to my saved trials
Anderson, South Carolina 29621
2008
mi
from 91732
Anderson, SC
Click here to add this to my saved trials
Ann Arbor, Michigan 48104
1933
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30342
1918
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78745
1212
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78703
1210
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Bardstown, Kentucky 40004
1829
mi
from 91732
Bardstown, KY
Click here to add this to my saved trials
Bellevue, Washington 98007
959
mi
from 91732
Bellevue, WA
Click here to add this to my saved trials
Berlin, New Jersey 08009
?
mi
from 91732
Berlin, NJ
Click here to add this to my saved trials
Birmingham, Alabama 35211
1782
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boise, Idaho 83704
666
mi
from 91732
Boise, ID
Click here to add this to my saved trials
Bryan, Texas 77802
1285
mi
from 91732
Bryan, TX
Click here to add this to my saved trials
Canoga Park, California 91303
?
mi
from 91732
Canoga Park, CA
Click here to add this to my saved trials
Chandler, Arizona 85224
358
mi
from 91732
Chandler, AZ
Click here to add this to my saved trials
Charlottesville, Virginia 22911
2211
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45249
1882
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44122
2041
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80918
807
mi
from 91732
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Georgia 31904
1901
mi
from 91732
Columbus, GA
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
1299
mi
from 91732
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas 75231
1226
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30030
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
Draper, Utah 84020
?
mi
from 91732
Draper, UT
Click here to add this to my saved trials
Encino, California 91316
29
mi
from 91732
Encino, CA
Click here to add this to my saved trials
Endwell, New York 13760
2324
mi
from 91732
Endwell, NY
Click here to add this to my saved trials
Evanston, Illinois 60201
1728
mi
from 91732
Evanston, IL
Click here to add this to my saved trials
Fargo, North Dakota 58104
1415
mi
from 91732
Fargo, ND
Click here to add this to my saved trials
2121 East Harmony Road
Fort Collins, Colorado 80528
839
mi
from 91732
Fort Collins, CO
Click here to add this to my saved trials
Hollywood, Florida 33021
2317
mi
from 91732
Hollywood, FL
Click here to add this to my saved trials
1002 Gemini Avenue
Houston, Texas 77058
1377
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Humble, Texas 77338
1358
mi
from 91732
Humble, TX
Click here to add this to my saved trials
Irvine, California 92618
32
mi
from 91732
Irvine, CA
Click here to add this to my saved trials
Jacksonville, Florida 32216
2135
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Jupiter, Florida 33458
2295
mi
from 91732
Jupiter, FL
Click here to add this to my saved trials
Kalamazoo, Michigan 49009
1833
mi
from 91732
Kalamazoo, MI
Click here to add this to my saved trials
Knoxville, Tennessee 37920
1925
mi
from 91732
Knoxville, TN
Click here to add this to my saved trials
La Mesa, California 91942
105
mi
from 91732
La Mesa, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Lemon Grove, California 91945
?
mi
from 91732
Lemon Grove, CA
Click here to add this to my saved trials
Lenexa, Kansas 66214
1331
mi
from 91732
Lenexa, KS
Click here to add this to my saved trials
Long Beach, California 90808
?
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Alamitos, California 90720
18
mi
from 91732
Los Alamitos, CA
Click here to add this to my saved trials
Louisville, Kentucky 40213
1815
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
Lyndhurst, Ohio 44124
2042
mi
from 91732
Lyndhurst, OH
Click here to add this to my saved trials
Madison, Wisconsin 53715
?
mi
from 91732
Madison, WI
Click here to add this to my saved trials
Manlius, New York 13104
2327
mi
from 91732
Manlius, NY
Click here to add this to my saved trials
Marlborough, Massachusetts 01752
2553
mi
from 91732
Marlborough, MA
Click here to add this to my saved trials
Martinsville, New Jersey 08836
2404
mi
from 91732
Martinsville, NJ
Click here to add this to my saved trials
Media, Pennsylvania 19063
2363
mi
from 91732
Media, PA
Click here to add this to my saved trials
Memphis, Tennessee 38119
1598
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
Meridian, Idaho 83642
664
mi
from 91732
Meridian, ID
Click here to add this to my saved trials
Mesa, Arizona 85201
357
mi
from 91732
Mesa, AZ
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
1509
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
2188
mi
from 91732
Mount Pleasant, SC
Click here to add this to my saved trials
New Orleans, Louisiana 70119
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10019
2433
mi
from 91732
New York, NY
Click here to add this to my saved trials
1410 North 13th Street
Norfolk, Nebraska 68701
1243
mi
from 91732
Norfolk, NE
Click here to add this to my saved trials
Oakland, California 94612
351
mi
from 91732
Oakland, CA
Click here to add this to my saved trials
Oceanside, California 92056
73
mi
from 91732
Oceanside, CA
Click here to add this to my saved trials
Ocoee, Florida 34761
2174
mi
from 91732
Ocoee, FL
Click here to add this to my saved trials
Ogden, Utah 84405
590
mi
from 91732
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
1165
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Olive Branch, Mississippi 38654
1600
mi
from 91732
Olive Branch, MS
Click here to add this to my saved trials
10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
1295
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
Omaha, Nebraska 68134
1295
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
Omaha, Nebraska 68130
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32806
2185
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
?
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
5151 Adanson Street
Orlando, Florida 32810
2181
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66211
1337
mi
from 91732
Overland Park, KS
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19114
2383
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85020
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Portland, Oregon 97210
829
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Prairie Village, Kansas 66206
1337
mi
from 91732
Prairie Village, KS
Click here to add this to my saved trials
Rancho Mirage, California 92270
94
mi
from 91732
Rancho Mirage, CA
Click here to add this to my saved trials
Rochester, New York 14609
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
796
mi
from 91732
Salem, OR
Click here to add this to my saved trials
San Diego, California 92108
103
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92103
103
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
San Marcos, California 92078
80
mi
from 91732
San Marcos, CA
Click here to add this to my saved trials
Santa Monica, California 90404
26
mi
from 91732
Santa Monica, CA
Click here to add this to my saved trials
109 Crossroads Road
Scottdale, Pennsylvania 15683
2142
mi
from 91732
Scottdale, PA
Click here to add this to my saved trials
Seattle, Washington 98105
964
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
Skillman, New Jersey 08558
2397
mi
from 91732
Skillman, NJ
Click here to add this to my saved trials
Smithfield, Pennsylvania 15478
2130
mi
from 91732
Smithfield, PA
Click here to add this to my saved trials
Spring Valley, California 91978
109
mi
from 91732
Spring Valley, CA
Click here to add this to my saved trials
Springfield, Missouri 65807
1399
mi
from 91732
Springfield, MO
Click here to add this to my saved trials
Stockbridge, Georgia 30281
1930
mi
from 91732
Stockbridge, GA
Click here to add this to my saved trials