12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
NCT ID: NCT03777059
Last Updated: 2021-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
910 participants
INTERVENTIONAL
2018-12-14
2020-06-19
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 tablets orally once daily for 12 weeks.
Placebo
Placebo-matching atogepant tablets
Atogepant 10 mg
Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Atogepant
Atogepant tablet
Placebo
Placebo-matching atogepant tablets
Atogepant 30 mg
Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Atogepant
Atogepant tablet
Placebo
Placebo-matching atogepant tablets
Atogepant 60 mg
Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Atogepant
Atogepant tablet
Placebo
Placebo-matching atogepant tablets
Interventions
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Atogepant
Atogepant tablet
Placebo
Placebo-matching atogepant tablets
Eligibility Criteria
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Inclusion Criteria
* Age of the participant at the time of migraine onset \<50 years.
Exclusion Criteria
* Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (e.g., 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.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
18 Years
80 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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Synexus Clinical Research US, Inc.
Chandler, Arizona, United States
Advanced Research Associates
Glendale, Arizona, United States
Alea Research Institute
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Orange Grove Family Practice
Tucson, Arizona, United States
Principals Research Group
Hot Springs, Arkansas, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Med Center Medical Clinic
Carmichael, California, United States
Triwest Research Associates
El Cajon, California, United States
Neuro Pain Medical Center
Fresno, California, United States
California Headache and Balance Center
Fresno, California, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
NervePro Research Bruce Cleeremans
Irvine, California, United States
Grossmont Center for Clinical Research
La Mesa, California, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, United States
Long Beach Clinical Trials Services
Long Beach, California, United States
Keck Medicine of USC
Los Angeles, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Newport Beach Clinical Research Associates
Newport Beach, California, United States
Excell Research, Inc.
Oceanside, California, United States
Stanford
Palo Alto, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
Desert Valley Research
Redlands, California, United States
George J. Rederich, M.D. Inc.
Redondo Beach, California, United States
Paradigm Clinical Research Centers, Inc
San Diego, California, United States
Optimus Medical Group
San Francisco, California, United States
California Neuroscience Research
Sherman Oaks, California, United States
Synexus Clinical Research US, Inc.
Vista, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Delta Waves, Inc.
Colorado Springs, Colorado, United States
Colorado Neurological Institute
Englewood, Colorado, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Aventura Neurological Associates
Aventura, Florida, United States
Neurology Offices of South Florida
Boca Raton, Florida, United States
Sarkis Clinical Trials- Gainesville
Gainesville, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Neurology Associates, P.A.
Maitland, Florida, United States
Well Pharma Medical Research, Corp.
Miami, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Sarasota Memorial Hospital Clinical Research Center
Sarasota, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Neurotrials Research
Atlanta, Georgia, United States
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
Atlanta, Georgia, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Diamond Headache Clinic Ltd
Chicago, Illinois, United States
Clinical Investigation Specialists
Gurnee, Illinois, United States
JWM Neurology
Indianapolis, Indiana, United States
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, United States
PMG Research, Inc. d/b/a PMG Research of McFarland Clinic
Ames, Iowa, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
College Park Family Care Center
Overland Park, Kansas, United States
Phoenix Medical Research
Prairie Village, Kansas, United States
Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, United States
Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, United States
Ochsner Clinic Foundation
Covington, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Mid-Atlantic Permanente Medical Group, PC
Largo, Maryland, United States
John R. Graham Headache Center Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States
BTC of New Bedford
New Bedford, Massachusetts, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Synexus Usa
Bay Saint Louis, Mississippi, United States
The Headache Center
Ridgeland, Mississippi, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Clinvest Research LLC.
Springfield, Missouri, United States
Synexus Clinical Research US, Inc.
Omaha, Nebraska, United States
Nevada Headache Institute
Las Vegas, Nevada, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Dent Neurologic Institute
Amherst, New York, United States
Northwell Health
Great Neck, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
Guilford Neurologic Associates, Inc
Greensboro, North Carolina, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
Wilmington Health, PLLC
Wilmington, North Carolina, United States
Piedmont Medical Research of Winston-Salem
Winston-Salem, North Carolina, United States
Synexus Clinical Research US, Inc.
Akron, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Sentral Clinical Research Services
Cincinnati, Ohio, United States
Aventiv Research Inc
Columbus, Ohio, United States
Family Physicians Associates
Lyndhurst, Ohio, United States
OK Clinical Research, LLC
Edmond, Oklahoma, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Centennial Health-Synexus
Oklahoma City, Oklahoma, United States
Tulsa Clinical Research
Tulsa, Oklahoma, United States
Oregon Center for Clinical Investigations
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Preferred Primary Care Physicians, Jacob Murphy
Uniontown, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, United States
Primary Care Associates/Synexus Clinical
Anderson, South Carolina, United States
Synexus Clinical Research US, Inc
Anderson, South Carolina, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Hillcrest Family Practice
Simpsonville, South Carolina, United States
ClinSearch
Chattanooga, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
CNS Healthcare - Memphis
Memphis, Tennessee, United States
Psychiatry & Psychotherapy Partners Austin
Austin, Texas, United States
Tekton Research
Austin, Texas, United States
Synexus-US
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Ventavia Research Group
Fort Worth, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Protenium Clinical Research
Hurst, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Synexus Clinical Research US, Inc.
San Antonio, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Synexus-US
Murray, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Highland Clinical Research
Salt Lake City, Utah, United States
J. Lewis Research, Inc.
South Jordan, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
National Clinical Research, Inc
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Sentara Family Medicine Physicians
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Eastside Therapeutic Resource and Core Clinical Research
Everett, Washington, United States
The Polyclinic
Seattle, Washington, United States
Puget Sound Neurology
Tacoma, 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.
Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23.
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.
Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305.
Lipton RB, Nahas SJ, Pozo-Rosich P, Bilchik T, McAllister P, Finnegan M, Liu Y, Chalermpalanupap N, Dabruzzo B, Dodick DW. Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial. J Headache Pain. 2024 May 21;25(1):83. doi: 10.1186/s10194-024-01783-6.
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.
Lipton RB, Pozo-Rosich P, Blumenfeld AM, Li Y, Severt L, Stokes JT, Creutz L, Gandhi P, Dodick D. Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial. Neurology. 2023 Feb 21;100(8):e764-e777. doi: 10.1212/WNL.0000000000201568. Epub 2022 Nov 17.
Lipton RB, Pozo-Rosich P, Blumenfeld AM, Dodick DW, McAllister P, Li Y, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Rates of Response to Atogepant for Migraine Prophylaxis Among Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2215499. doi: 10.1001/jamanetworkopen.2022.15499.
Schwedt TJ, Lipton RB, Ailani J, Silberstein SD, Tassorelli C, Guo H, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. Cephalalgia. 2022 Jan;42(1):3-11. doi: 10.1177/03331024211042385. Epub 2021 Sep 14.
Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, Finnegan M, Trugman JM; ADVANCE Study Group. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706. doi: 10.1056/NEJMoa2035908.
Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.
Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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3101-301-002
Identifier Type: -
Identifier Source: org_study_id
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