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

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.

Study Overview

• Status: Completed
• Conditions: Episodic Migraine
• Intervention / Treatment: Drug: Atogepant

• Study Type: Interventional
• Enrollment (Actual): 685
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synexus Clinical Research US, Inc.
    • Phoenix, Arizona, United States, 85012
      • Alea Research
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Medical Clinic
    • Tucson, Arizona, United States, 85741
      • Orange Grove Family Practice
  • Arkansas
    • Hot Springs, Arkansas, United States, 71901
      • Principals Research Group
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Clinical Research
  • California
    • Carmichael, California, United States, 95608
      • Med Center Medical Clinic
    • Fresno, California, United States, 93710
      • Neuro Pain Medical Center
    • Fresno, California, United States, 93720
      • California Headache and Balance Center
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • La Mesa, California, United States, 91942
      • Paradigm Clinical Research Centers, Inc
    • Lomita, California, United States, 90731
      • Torrance Clinical Research Institute, Inc.
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials Services
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92663
      • Newport Beach Clinical Research Associates
    • Oceanside, California, United States, 92056
      • Excell Research, Inc.
    • Rancho Cucamonga, California, United States, 91730
      • Rancho Cucamonga Clinical Trials
    • Redlands, California, United States, 92374
      • Desert Valley Research
    • Redondo Beach, California, United States, 90277
      • George J. Rederich, M.D. Inc.
    • San Francisco, California, United States, 94102
      • Optimus Medical Group
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Clinical Research
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Neurological Associates
    • Boca Raton, Florida, United States, 33428
      • Neurology Offices of South Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials- Gainesville
    • Jacksonville, Florida, United States, 32205
      • Westside Center for Clinical Research
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Miami, Florida, United States, 33173
      • Well Pharma Medical Research, Corp
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates of Ormond Beach
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital Clinical Research Center
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Synexus Clinical Research, Inc
    • Atlanta, Georgia, United States, 30328
      • Neurotrials Research
    • Atlanta, Georgia, United States, 30328
      • Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60642
      • Diamond Headache Clinic Ltd
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • JWM Neurology
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic - Gateway Health Center
  • Iowa
    • Ames, Iowa, United States, 50010
      • PMG Research, Inc. d/b/a PMG Research of McFarland Clinic
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Overland Park, Kansas, United States, 66212
      • College Park Family Care Center
    • Prairie Village, Kansas, United States, 66208
      • Collective Medical Research
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates, LLC - An AMR Company
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC - An AMR Company
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • DelRicht Research
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02103
      • John R. Graham Headache Center Brigham and Women's Faulkner Hospital
    • New Bedford, Massachusetts, United States, 02740
      • BTC of New Bedford
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • The Headache Center
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research
    • Springfield, Missouri, United States, 65810
      • Clinvest Research LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Synexus Clinical Research US, Inc.
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte, LLC
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates, P.A.
    • Rocky Mount, North Carolina, United States, 27804
      • PMG Research of Rocky Mount, LLC
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Health, PLLC
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Medical Research of Winston-Salem
  • Ohio
    • Akron, Ohio, United States, 44311
      • Synexus Clinical Research US, Inc.
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Sites
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Columbus, Ohio, United States, 43212
      • Aventiv Research Inc
    • Lyndhurst, Ohio, United States, 44124
      • Ohio Clinical Research, LLC
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research, LLC
    • Norman, Oklahoma, United States, 72069
      • Lynn Institute of Norman
    • Tulsa, Oklahoma, United States, 74136
      • Tulsa Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
    • Uniontown, Pennsylvania, United States, 15401
      • Preferred Primary Care Physicians, Jacob Murphy
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Neurological Associates
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Partners in Clinical Research, LLC
    • Lincoln, Rhode Island, United States, 02865
      • Ocean State Clinical Research Partners
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Primary Care Associates/Synexus Clinical
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Simpsonville, South Carolina, United States, 29681
      • Hillcrest Family Practice
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Kingsport, Tennessee, United States, 37760
      • Holston Medical Group
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research
    • Austin, Texas, United States, 78737
      • Psychiatry & Psychotherapy Partners Austin
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75234
      • Synexus-US
    • Fort Worth, Texas, United States, 76104
      • Ventavia Research Group
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc.
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas
    • San Antonio, Texas, United States, 78229
      • Synexus Clinical Research, Inc
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
    • Salt Lake City, Utah, United States, 84123
      • Synexus-US
    • South Jordan, Utah, United States, 84095
      • J. Lewis Research, Inc.
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Inc
    • Virginia Beach, Virginia, United States, 23456
      • Sentara Neruology Specialists
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Clinical Research Center
    • Everett, Washington, United States, 98201
      • Eastside Therapeutic Resource and Core Clinical Research
    • Tacoma, Washington, United States, 98409
      • Puget Sound Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Atogepant 60 mg; Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.	Drug: Atogepant; Atogepant Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator	Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.	Up to Week 44
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator	12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.	Up to Week 40
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator	PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.	Up to Week 44
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.	OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2019
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (ACTUAL): May 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Migraine; Aura
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 3101-309-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No