Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
NCT ID: NCT02848326
Last Updated: 2018-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
834 participants
INTERVENTIONAL
2016-09-06
2018-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Atogepant 10 mg QD
Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
Atogepant
Atogepant capsule.
Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Atogepant 30 mg QD
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
Atogepant
Atogepant capsule.
Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Atogepant 30 mg BID
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Atogepant
Atogepant capsule.
Atogepant 60 mg QD
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
Atogepant
Atogepant capsule.
Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Atogepant 60 mg BID
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Atogepant
Atogepant capsule.
Interventions
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Atogepant
Atogepant capsule.
Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age of the patient at the time of migraine onset \< 50 years
* History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
* Demonstrated compliance with e-diary
Exclusion Criteria
* Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
* Difficulty distinguishing migraine headache from other headaches
* Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
* Has a history of hepatitis within previous 6 months
* Usage of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs \[NSAIDs\], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
* Pregnant or nursing females
18 Years
75 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Trugman, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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Achieve Clinical Research
Birmingham, Alabama, United States
Radiant Research, Inc.
Chandler, Arizona, United States
The Research Center of Southern California, LLC
Carlsbad, California, United States
Neuro-Pain Medical Center, Inc
Fresno, California, United States
Irvine Center for Clinical Research
Irvine, California, United States
Downtown LA Research Center, Inc.
Los Angeles, California, United States
Excell Research
Oceanside, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
Diablo Clinical Research Inc
Walnut Creek, California, United States
Advanced Neurosciences Research
Fort Collins, Colorado, United States
Hartford Headache Center
East Hartford, Connecticut, United States
Associated Neurologists of Southern Connecticut, P. C.
Fairfield, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
The George Washington University
Washington D.C., District of Columbia, United States
Clinical Research South Florida
Coral Gables, Florida, United States
Infinity Clinical Research
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States
Meridien Research
Maitland, Florida, United States
Suncoast Research
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Palm Beach Neurological Center / Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
Infinity Clinical Research LLC
Sunrise, Florida, United States
Meridien Research
Tampa, Florida, United States
Neurology Research Institute Palm Beach
West Palm Beach, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
Radiant Research
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
Sandy Springs, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, United States
Healthcare Research Network II, LLC
Blue Island, Illinois, United States
Rowe Neurology Institute
Lenexa, Kansas, United States
Boston Clinical Trials Inc
Boston, Massachusetts, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States
Medvadis Research Corporation
Watertown, Massachusetts, United States
New England Regional Headache Center
Worcester, Massachusetts, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Mercy Research
Springfield, Missouri, United States
Clinvest
Springfield, Missouri, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Altea Research Institute
Las Vegas, Nevada, United States
Renown Institute for Neuroscience
Reno, Nevada, United States
Hassman Research Institute - NJ
Berlin, New Jersey, United States
Amici Clinical Research
Warren Township, New Jersey, United States
DENT Neurosciences Research Center
Amherst, New York, United States
Radiant Research, Inc.
Jamaica, New York, United States
Carolina Headache Institute
Durham, North Carolina, United States
Wake Research Associates LLC
Raleigh, North Carolina, United States
Ohio Clinical Research, LLC
Willoughby Hills, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Cns Healthcare
Memphis, Tennessee, United States
Nashville Neuroscience Group
Nashville, Tennessee, United States
Tekton Research
Austin, Texas, United States
DermResearch Inc
Austin, Texas, United States
DiscoveResearch, Inc.
Bryan, Texas, United States
Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America
Dallas, Texas, United States
Central Texas Neurology Consultant
Round Rock, Texas, United States
Radiant Research, San Antonio Center for Clinical Research
San Antonio, Texas, United States
Road Runner Research LTD
San Antonio, Texas, United States
ClinPoint Trials, LLC
Waxahachie, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Women's Clinical Research Center
Seattle, Washington, United States
Kingfisher Cooperative, LLC
Spokane, Washington, United States
Countries
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References
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Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.
Peterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.
Rizzoli P, Marmura MJ, Robblee J, McVige J, Sacco S, Nahas SJ, Ailani J, De Abreu Ferreira R, Ma J, Smith JH, Dabruzzo B, Ashina M. Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials. J Headache Pain. 2024 Mar 11;25(1):35. doi: 10.1186/s10194-024-01736-z.
Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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http://www.allerganclinicaltrials.com
Other Identifiers
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CGP-MD-01
Identifier Type: -
Identifier Source: org_study_id
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