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Episodic MigrainePhase 3NCT03939312

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 study testing Atogepant in people with Episodic Migraine, run by Allergan at 113 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Episodic Migraine
What is being tested?
Atogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
685 participants
Where
113 sitesUnited States
Study dates
6 May 2019to 31 Mar 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

113 sites in 1 country.

113 sites in 1 country

United States113 sites

  • Synexus Clinical Research US, Inc.

    Akron, Ohio, 44311

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • PMG Research, Inc. d/b/a PMG Research of McFarland Clinic

    Ames, Iowa, 50010

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Primary Care Associates/Synexus Clinical

    Anderson, South Carolina, 29621

  • Neurotrials Research

    Atlanta, Georgia, 30328

  • Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology

    Atlanta, Georgia, 30328

  • Synexus Clinical Research, Inc

    Atlanta, Georgia, 30328

  • Psychiatry & Psychotherapy Partners Austin

    Austin, Texas, 78737

  • Tekton Research

    Austin, Texas, 78745

  • Aventura Neurological Associates

    Aventura, Florida, 33180

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • Northwest Clinical Research Center

    Bellevue, Washington, 98004

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

  • John R. Graham Headache Center Brigham and Women's Faulkner Hospital

    Boston, Massachusetts, 02103

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • Med Center Medical Clinic

    Carmichael, California, 95608

  • Synexus Clinical Research US, Inc.

    Chandler, Arizona, 85224

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28209

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • ClinSearch

    Chattanooga, Tennessee, 37421

  • Diamond Headache Clinic Ltd

    Chicago, Illinois, 60642

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Patient Priority Clinical Sites

    Cincinnati, Ohio, 45215

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45242

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Aventiv Research Inc

    Columbus, Ohio, 43212

  • Partners in Clinical Research, LLC

    Cumberland, Rhode Island, 02864

  • Synexus-US

    Dallas, Texas, 75234

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Eastside Therapeutic Resource and Core Clinical Research

    Everett, Washington, 98201

  • Ventavia Research Group

    Fort Worth, Texas, 76104

  • Neuro Pain Medical Center

    Fresno, California, 93710

  • California Headache and Balance Center

    Fresno, California, 93720

  • Sarkis Clinical Trials- Gainesville

    Gainesville, Florida, 32607

  • Principals Research Group

    Hot Springs, Arkansas, 71901

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • JWM Neurology

    Indianapolis, Indiana, 46256

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Holston Medical Group

    Kingsport, Tennessee, 37760

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • Paradigm Clinical Research Centers, Inc

    La Mesa, California, 91942

  • Ocean State Clinical Research Partners

    Lincoln, Rhode Island, 02865

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90731

  • Long Beach Clinical Trials Services

    Long Beach, California, 90806

  • Ohio Clinical Research, LLC

    Lyndhurst, Ohio, 44124

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Well Pharma Medical Research, Corp

    Miami, Florida, 33173

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740

  • DelRicht Research

    New Orleans, Louisiana, 70124

  • Deaconess Clinic - Gateway Health Center

    Newburgh, Indiana, 47630

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Newport Beach Clinical Research Associates

    Newport Beach, California, 92663

  • Health Research of Hampton Roads

    Newport News, Virginia, 23606

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • Lynn Institute of Norman

    Norman, Oklahoma, 72069

  • Excell Research, Inc.

    Oceanside, California, 92056

  • Synexus Clinical Research US, Inc.

    Omaha, Nebraska, 68144

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • College Park Family Care Center

    Overland Park, Kansas, 66212

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Alea Research

    Phoenix, Arizona, 85012

  • Central Phoenix Medical Clinic

    Phoenix, Arizona, 85020

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • Collective Medical Research

    Prairie Village, Kansas, 66208

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina, 27607

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • Rancho Cucamonga Clinical Trials

    Rancho Cucamonga, California, 91730

  • Desert Valley Research

    Redlands, California, 92374

  • George J. Rederich, M.D. Inc.

    Redondo Beach, California, 90277

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • The Headache Center

    Ridgeland, Mississippi, 39157

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Synexus-US

    Salt Lake City, Utah, 84123

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Synexus Clinical Research, Inc

    San Antonio, Texas, 78229

  • Optimus Medical Group

    San Francisco, California, 94102

  • Sarasota Memorial Hospital Clinical Research Center

    Sarasota, Florida, 34239

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • California Neuroscience Research

    Sherman Oaks, California, 91403

  • Hillcrest Family Practice

    Simpsonville, South Carolina, 29681

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • J. Lewis Research, Inc.

    South Jordan, Utah, 84095

  • Clinvest Research LLC

    Springfield, Missouri, 65810

  • Meridien Research

    St. Petersburg, Florida, 33709

  • New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Puget Sound Neurology

    Tacoma, Washington, 98409

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • University of South Florida

    Tampa, Florida, 33612

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Orange Grove Family Practice

    Tucson, Arizona, 85741

  • Tulsa Clinical Research

    Tulsa, Oklahoma, 74136

  • Preferred Primary Care Physicians, Jacob Murphy

    Uniontown, Pennsylvania, 15401

  • Sentara Neruology Specialists

    Virginia Beach, Virginia, 23456

  • ClinPoint Trials

    Waxahachie, Texas, 75165

  • Heartland Research Associates, LLC - An AMR Company

    Wichita, Kansas, 67205

  • Heartland Research Associates, LLC - An AMR Company

    Wichita, Kansas, 67207

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

  • Wilmington Health, PLLC

    Wilmington, North Carolina, 28401

  • Piedmont Medical Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Being tested
Atogepant
Keywords
Migraine, Aura
Medical subject headings
Migraine Disorders, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtogepantDrug

    Atogepant Tablets

Study groups in NCT03939312
Study groupRoleWhat they receive
Atogepant 60 mgExperimentalParticipants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.
Receives: Drug: Atogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)

Secondary outcomes (4)

  1. 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.

    Measured: Up to Week 44

  2. 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.

    Measured: Up to Week 40

  3. 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.

    Measured: Up to Week 44

  4. 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.

    Measured: OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start6 May 2019
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
685 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03939312
Sponsor's protocol ID
3101-309-002
Status last verified
Apr 2022
First submitted
3 May 2019
Last updated
12 May 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39648629

  • 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.

    PubMed 38462625

  • 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.

    PubMed 33942560

  • 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.

    PubMed 33142014

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant in people with Episodic Migraine, run by Allergan at 113 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) (time frame: From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03939312, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.

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