Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
A Phase 3, Multicenter, Open-Label 40-week Extension 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
685
1 country
113
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2019
113 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
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 6, 2019
CompletedStudy Start
First participant enrolled
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
May 12, 2022
CompletedMay 12, 2022
April 1, 2022
1.9 years
May 3, 2019
March 15, 2022
April 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Secondary Outcomes (4)
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator
Up to Week 44
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator
Up to Week 40
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
Up to Week 44
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS)
OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44
Study Arms (1)
Atogepant 60 mg
EXPERIMENTALParticipants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Participants must be using a medically acceptable and effective method of birth control during the course of the entire study.
- Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).
You may not qualify if:
- 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 at Visit 1.
- Hypertension as defined by sitting systolic BP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg at Visit 1.
- Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (113)
Synexus Clinical Research US, Inc.
Chandler, Arizona, 85224, United States
Alea Research
Phoenix, Arizona, 85012, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Principals Research Group
Hot Springs, Arkansas, 71901, United States
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Med Center Medical Clinic
Carmichael, California, 95608, United States
Neuro Pain Medical Center
Fresno, California, 93710, United States
California Headache and Balance Center
Fresno, California, 93720, United States
Grossmont Center for Clinical Research
La Mesa, California, 91942, United States
Paradigm Clinical Research Centers, Inc
La Mesa, California, 91942, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, 90731, United States
Long Beach Clinical Trials Services
Long Beach, California, 90806, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Newport Beach Clinical Research Associates
Newport Beach, California, 92663, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, 91730, United States
Desert Valley Research
Redlands, California, 92374, United States
George J. Rederich, M.D. Inc.
Redondo Beach, California, 90277, United States
Optimus Medical Group
San Francisco, California, 94102, United States
California Neuroscience Research
Sherman Oaks, California, 91403, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Aventura Neurological Associates
Aventura, Florida, 33180, United States
Neurology Offices of South Florida
Boca Raton, Florida, 33428, United States
Sarkis Clinical Trials- Gainesville
Gainesville, Florida, 32607, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Well Pharma Medical Research, Corp
Miami, Florida, 33173, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Sarasota Memorial Hospital Clinical Research Center
Sarasota, Florida, 34239, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
University of South Florida
Tampa, Florida, 33612, United States
Neurotrials Research
Atlanta, Georgia, 30328, United States
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
Atlanta, Georgia, 30328, United States
Synexus Clinical Research, Inc
Atlanta, Georgia, 30328, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Diamond Headache Clinic Ltd
Chicago, Illinois, 60642, United States
JWM Neurology
Indianapolis, Indiana, 46256, United States
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, 47630, United States
PMG Research, Inc. d/b/a PMG Research of McFarland Clinic
Ames, Iowa, 50010, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
College Park Family Care Center
Overland Park, Kansas, 66212, United States
Collective Medical Research
Prairie Village, Kansas, 66208, United States
Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, 67205, United States
Heartland Research Associates, LLC - An AMR Company
Wichita, Kansas, 67207, United States
DelRicht Research
New Orleans, Louisiana, 70124, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
John R. Graham Headache Center Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02103, United States
BTC of New Bedford
New Bedford, Massachusetts, 02740, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
The Headache Center
Ridgeland, Mississippi, 39157, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65810, United States
Synexus Clinical Research US, Inc.
Omaha, Nebraska, 68144, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
Wilmington Health, PLLC
Wilmington, North Carolina, 28401, United States
Piedmont Medical Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Synexus Clinical Research US, Inc.
Akron, Ohio, 44311, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, 45215, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Aventiv Research Inc
Columbus, Ohio, 43212, United States
Ohio Clinical Research, LLC
Lyndhurst, Ohio, 44124, United States
OK Clinical Research, LLC
Edmond, Oklahoma, 73034, United States
Lynn Institute of Norman
Norman, Oklahoma, 72069, United States
Tulsa Clinical Research
Tulsa, Oklahoma, 74136, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
Preferred Primary Care Physicians, Jacob Murphy
Uniontown, Pennsylvania, 15401, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090, United States
Partners in Clinical Research, LLC
Cumberland, Rhode Island, 02864, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, 02865, United States
Primary Care Associates/Synexus Clinical
Anderson, South Carolina, 29621, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
Hillcrest Family Practice
Simpsonville, South Carolina, 29681, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
Holston Medical Group
Kingsport, Tennessee, 37760, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Psychiatry & Psychotherapy Partners Austin
Austin, Texas, 78737, United States
Tekton Research
Austin, Texas, 78745, United States
Synexus-US
Dallas, Texas, 75234, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Ventavia Research Group
Fort Worth, Texas, 76104, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Synexus Clinical Research, Inc
San Antonio, Texas, 78229, United States
ClinPoint Trials
Waxahachie, Texas, 75165, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Synexus-US
Salt Lake City, Utah, 84123, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
J. Lewis Research, Inc.
South Jordan, Utah, 84095, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Health Research of Hampton Roads
Newport News, Virginia, 23606, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
Sentara Neruology Specialists
Virginia Beach, Virginia, 23456, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Eastside Therapeutic Resource and Core Clinical Research
Everett, Washington, 98201, United States
Puget Sound Neurology
Tacoma, Washington, 98409, United States
Related Publications (4)
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: 39648629DERIVEDRizzoli 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: 38462625DERIVEDBoinpally 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 6, 2019
Study Start
May 6, 2019
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
May 12, 2022
Results First Posted
May 12, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.