Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
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
1 other identifier
interventional
744
1 country
112
Brief Summary
This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2018
CompletedStudy Start
First participant enrolled
October 8, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2020
CompletedResults Posted
Study results publicly available
June 15, 2021
CompletedJune 15, 2021
May 1, 2021
1.6 years
September 25, 2018
May 20, 2021
May 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.
From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Secondary Outcomes (4)
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator
From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator
Up to Week 52
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator
From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior
Up to Week 52
Study Arms (2)
Oral SOC Migraine Preventive Medication
ACTIVE COMPARATOROral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
Atogepant 60 mg
EXPERIMENTALAtogepant 60 mg tablet taken orally, once daily for 52 weeks.
Interventions
Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
Eligibility Criteria
You may qualify if:
- Written informed consent and participant privacy information (e.g., 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 migraine prevention medications and the participant is willing to accept SOC 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
You may not qualify if:
- 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 chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., 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 (e.g., aspirin, nonsteroidal anti-inflammatory drugs (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, gastrointestinal (GI), or neurologic disease
- Hypertension as defined by sitting systolic blood pressure (BP) \> 160 millimeter of mercury (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 (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (112)
Clinical Research Advantage, Inc./Simon Williamson Clinic, PC
Birmingham, Alabama, 35211, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Synexus Clinical Research US, Inc./East Valley Family Physicians PLC
Chandler, Arizona, 85224, United States
Synexus Clinical Research US, Inc./Desert Clinical Research, LLC
Mesa, Arizona, 85213, United States
Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, 85020, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Sun Valley Research Center, Inc.
Imperial, California, 92251, United States
Irvine Center for Clinical Research
Irvine, California, 92614, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
Desert Valley Research
Redlands, California, 92374, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
California Research Foundation
San Diego, California, 92123-1881, United States
Artemis Institute for Clinical Research
San Marcos, California, 92078, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Synexus Clinical Research US, Inc.
Vista, California, 92083, United States
Diablo Clinical Research, Inc
Walnut Creek, California, 94598, United States
Delta Waves, Inc.
Colorado Springs, Colorado, 80918, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
MD Clinical
Hallandale, Florida, 33009, United States
Infinity Clinical Research
Hollywood, Florida, 33024, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Meridien Research
Maitland, Florida, 32751, United States
Well Pharma Medical Research, Corp.
Miami, Florida, 33173, United States
Sensible Healthcare LLC
Ocoee, Florida, 34761, United States
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801, United States
Bioclinica Research
Orlando, Florida, 32806, United States
Infinity Clinical Research LLC
Sunrise, Florida, 33351, United States
Meridien Research
Tampa, Florida, 33634, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328, United States
Atlanta Center for Clinical Research
Atlanta, Georgia, 30331, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute
Lenexa, Kansas, 66214, United States
Kansas Institute of Research
Overland Park, Kansas, 66211, United States
Phoenix Medical Research, Inc.
Prairie Village, Kansas, 66208, United States
Kentucky Pediatric Research
Bardstown, Kentucky, 40004, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Community Clinical Research Network
Marlborough, Massachusetts, 01752, United States
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
ClinVest
Springfield, Missouri, 65810, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Synexus Clinical Research US, Inc
Omaha, Nebraska, 68144, United States
Altea Research Institute
Las Vegas, Nevada, 89102, United States
Hassman Research Institutes
Berlin, New Jersey, 08009, United States
Amici Clinical Research
Raritan, New Jersey, 08869, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Synexus Clinical Research US, Inc.
Jamaica, New York, 11432, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221, United States
Plains Clinical Medical Clinic, LLC
Fargo, North Dakota, 58104, United States
Synexus Clinical Research US, Inc.
Akron, Ohio, 44311, United States
Synexus Clinical Research US, Inc.
Cincinnati, Ohio, 45236, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Ohio Clinical Research, LLC
Willoughby Hills, Ohio, 44094, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Summit Research Network
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
Radiant Research, Inc.
Anderson, South Carolina, 29621, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, 57049, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
CNS Healthcare - Memphis
Memphis, Tennessee, 38119, United States
Trinity Clinical Research
Tullahoma, Tennessee, 37388, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Tekton Research, Inc
Austin, Texas, 78745, United States
DiscoveResearch, Inc.
Bryan, Texas, 77802, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Earle Research
Houston, Texas, 77058, United States
Research Trials WorldWide, LLC
Humble, Texas, 77338, United States
Synexus Clinical Research US, Inc.
San Antonio, Texas, 78229, United States
ClinPoint Trials
Waxahachie, Texas, 75165, United States
J. Lewis Research, Inc./Foothill Family Clinic Draper
Draper, Utah, 84020, United States
Advanced Research Institute
Ogden, Utah, 84403, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Seattle Women's: Health, Research
Seattle, Washington, 98105, United States
SSM Dean Health Research
Madison, Wisconsin, 53715, United States
Related Publications (6)
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.
PMID: 39648629DERIVEDLipton 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.
PMID: 38773375DERIVEDRizzoli 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.
PMID: 38462625DERIVEDLipton RB, Halker Singh RB, Mechtler L, McVige J, Ma J, Yu SY, Stokes J, Dabruzzo B, Gandhi P, Ashina M. Patient-reported migraine-specific quality of life, activity impairment and headache impact with once-daily atogepant for preventive treatment of migraine in a randomized, 52-week trial. Cephalalgia. 2023 Aug;51(8):3331024231190296. doi: 10.1177/03331024231190296.
PMID: 37638400DERIVEDBoinpally 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.
PMID: 33942560DERIVEDMin 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.
PMID: 33142014DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Joel Trugman, MD
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2018
First Posted
October 9, 2018
Study Start
October 8, 2018
Primary Completion
May 21, 2020
Study Completion
May 21, 2020
Last Updated
June 15, 2021
Results First Posted
June 15, 2021
Record last verified: 2021-05