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Episodic MigrainePhase 3NCT03777059

12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

A Phase 3 study testing Atogepant in people with Episodic Migraine, run by Allergan at 138 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

To evaluate the safety and tolerability of atogepant 30 mg and 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?
Yes, some participants may receive a placebo
How many people
910 participants
Where
138 sitesUnited States
Study dates
14 Dec 2018to 19 Jun 2020
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

  • 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.

Who cannot join

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine.
  • 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.

Trial locations and contacts

138 sites in 1 country.

138 sites in 1 country

United States138 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 Neurologic Institute

    Amherst, New York, 14226

  • Primary Care Associates/Synexus Clinical

    Anderson, South Carolina, 29621

  • Synexus Clinical Research US, Inc

    Anderson, South Carolina, 29621

  • Neurotrials Research

    Atlanta, Georgia, 30328

  • Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology

    Atlanta, Georgia, 30328

  • Synexus Clinical Research US, 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

  • Synexus Usa

    Bay Saint Louis, Mississippi, 63141

  • 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, 02130

  • 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

  • Sentral Clinical Research Services

    Cincinnati, Ohio, 45242

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Delta Waves, Inc.

    Colorado Springs, Colorado, 80918

  • Aventiv Research Inc

    Columbus, Ohio, 43213

  • Ochsner Clinic Foundation

    Covington, Louisiana, 70433

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Synexus-US

    Dallas, Texas, 75234

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • OK Clinical Research, LLC

    Edmond, Oklahoma, 73034

  • Triwest Research Associates

    El Cajon, California, 92020

  • 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

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Sarkis Clinical Trials- Gainesville

    Gainesville, Florida, 32607

  • Advanced Research Associates

    Glendale, Arizona, 85308

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Northwell Health

    Great Neck, New York, 11021

  • Guilford Neurologic Associates, Inc

    Greensboro, North Carolina, 27405

  • Clinical Investigation Specialists

    Gurnee, Illinois, 60031

  • Principals Research Group

    Hot Springs, Arkansas, 71901

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • JWM Neurology

    Indianapolis, Indiana, 46256

  • NervePro Research Bruce Cleeremans

    Irvine, California, 92618

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • Mid-Atlantic Permanente Medical Group, PC

    Largo, Maryland, 20774

  • Nevada Headache Institute

    Las Vegas, Nevada, 89113

  • 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

  • Keck Medicine of USC

    Los Angeles, California, 90033

  • Family Physicians Associates

    Lyndhurst, Ohio, 44124

  • Neurology Associates, P.A.

    Maitland, Florida, 32751

  • CNS Healthcare - Memphis

    Memphis, Tennessee, 38119

  • Well Pharma Medical Research, Corp.

    Miami, Florida, 33143

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Synexus-US

    Murray, Utah, 84123

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • 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, Inc.

    Newport News, Virginia, 23606

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • Lynn Institute of Norman

    Norman, Oklahoma, 73069

  • Excell Research, Inc.

    Oceanside, California, 92056

  • Centennial Health-Synexus

    Oklahoma City, Oklahoma, 73111

  • 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

  • Stanford

    Palo Alto, California, 94304

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Alea Research Institute

    Phoenix, Arizona, 85012

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • Oregon Center for Clinical Investigations

    Portland, Oregon, 97214

  • Phoenix 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 Research

    Rancho Cucamonga, California, 91730

  • Desert Valley Research

    Redlands, California, 92374

  • George J. Rederich, M.D. Inc.

    Redondo Beach, California, 90277

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • 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

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas, 78229

  • Paradigm Clinical Research Centers, Inc

    San Diego, California, 92117

  • Optimus Medical Group

    San Francisco, California, 94102

  • Sarasota Memorial Hospital Clinical Research Center

    Sarasota, Florida, 34239

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • The Polyclinic

    Seattle, Washington, 98104

  • 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, 25328

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • University of South Florida

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Orange Grove Family Practice

    Tucson, Arizona, 85741

  • Tulsa Clinical Research

    Tulsa, Oklahoma, 74104

  • Preferred Primary Care Physicians, Jacob Murphy

    Uniontown, Pennsylvania, 15401

  • Sentara Family Medicine Physicians

    Virginia Beach, Virginia, 23456

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083

  • 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, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)

To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Being tested
Atogepant, Placebo
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 tablet

  • PlaceboDrug

    Placebo-matching atogepant tablets

Study groups in NCT03777059
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo-matching atogepant tablets orally once daily for 12 weeks.
Receives: Drug: Placebo
Atogepant 10 mgExperimentalAtogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Receives: Drug: Atogepant; Drug: Placebo
Atogepant 30 mgExperimentalAtogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Receives: Drug: Atogepant; Drug: Placebo
Atogepant 60 mgExperimentalAtogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Receives: Drug: Atogepant; Drug: Placebo

What is being measured

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

  1. Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period

    Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.

    Measured: Baseline (Day -28 to Day -1) to Week 12

Secondary outcomes (6)

  1. Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period

    Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.

    Measured: Baseline (Day-28 to Day -1) to Week 12

  2. Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period

    Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.

    Measured: Baseline (Day-28 to Day -1) to Week 12

  3. Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days

    Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days is equal to total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.

    Measured: Baseline (Day -28 to Day -1) to Week 12

  4. Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12

    MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.

    Measured: Baseline (Day 1) to Week 12

  5. Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period

    The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.

    Measured: Baseline (Day -28 to Day -1) to Week 12

  6. Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period

    The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.

    Measured: Baseline (Day -28 to Day -1) to Week 12

Timeline

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

  1. First posted17 Dec 2018
  2. Study start14 Dec 2018
  3. Primary completion19 Jun 2020
  4. Study completion19 Jun 2020

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
910 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777059
Sponsor's protocol ID
3101-301-002
Status last verified
Jun 2021
First submitted
13 Dec 2018
Last updated
9 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39982105

  • 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.

    PubMed 39715475

  • 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

  • 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.

    PubMed 39648617

  • 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.

    PubMed 38773375

  • 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

  • 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.

    PubMed 36396451

  • 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.

    PubMed 35675076

  • 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.

    PubMed 34521260

  • 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.

    PubMed 34407343

  • 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 138 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 2 inclusion and 4 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 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 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. Some participants in this study may receive a placebo. 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 9 Jul 2021). 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?

Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period (time frame: Baseline (Day -28 to Day -1) to Week 12). 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 NCT03777059, which also lists 12 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 9 Jul 2021.

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