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Migraine, With or Without AuraPhase 2/3NCT02848326

Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

A Phase 2/3 study testing Atogepant in people with Migraine, With or Without Aura, run by Allergan at 75 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

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine, With or Without Aura
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
834 participants
Where
75 sitesUnited States
Study dates
6 Sep 2016to 23 Apr 2018
Phase
Phase 2/3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has at least a 1-year history of migraine with or without aura
  • Age of the patient at the time of migraine onset < 50 years
  • History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment
  • Demonstrated compliance with e-diary

Who cannot join

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine
  • Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
  • Difficulty distinguishing migraine headache from other headaches
  • Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption
  • Has a history of hepatitis within previous 6 months
  • Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
  • Pregnant or nursing females

Trial locations and contacts

75 sites in 1 country.

75 sites in 1 country

United States75 sites

  • Lehigh Center For Clinical Research

    Allentown, Pennsylvania, 18104

  • Institute for Advanced Medical Research

    Alpharetta, Georgia, 30005

  • DENT Neurosciences Research Center

    Amherst, New York, 14226

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • Radiant Research

    Atlanta, Georgia, 30328

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Tekton Research

    Austin, Texas, 78745

  • DermResearch Inc

    Austin, Texas, 78759

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Hassman Research Institute - NJ

    Berlin, New Jersey, 08009

  • Achieve Clinical Research

    Birmingham, Alabama, 35216

  • Healthcare Research Network II, LLC

    Blue Island, Illinois, 60406

  • Northwest Clinical Trials, Inc.

    Boise, Idaho, 83704

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 02131

  • DiscoveResearch, Inc.

    Bryan, Texas, 77802

  • The Research Center of Southern California, LLC

    Carlsbad, California, 92011

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Clinical Research South Florida

    Coral Gables, Florida, 33134

  • Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America

    Dallas, Texas, 75234

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Carolina Headache Institute

    Durham, North Carolina, 27713

  • Hartford Headache Center

    East Hartford, Connecticut, 06118

  • Associated Neurologists of Southern Connecticut, P. C.

    Fairfield, Connecticut, 06824

  • Advanced Neurosciences Research

    Fort Collins, Colorado, 80528

  • Neuro-Pain Medical Center, Inc

    Fresno, California, 93710

  • Infinity Clinical Research

    Hollywood, Florida, 33021

  • Irvine Center for Clinical Research

    Irvine, California, 92618

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida, 32256

  • Radiant Research, Inc.

    Jamaica, New York, 11432

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Rowe Neurology Institute

    Lenexa, Kansas, 66214

  • Downtown LA Research Center, Inc.

    Los Angeles, California, 90017

  • Meridien Research

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Cns Healthcare

    Memphis, Tennessee, 38119

  • Suncoast Research

    Miami, Florida, 33135

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Nashville Neuroscience Group

    Nashville, Tennessee, 37203

  • Northeast Medical Research Associates, Inc.

    North Dartmouth, Massachusetts, 02747

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Excell Research

    Oceanside, California, 92056

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research, Inc

    Omaha, Nebraska, 68114

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801

  • Palm Beach Neurological Center / Advanced Research Consultants, Inc.

    Palm Beach Gardens, Florida, 33410

  • Wake Research Associates LLC

    Raleigh, North Carolina, 27612

  • Renown Institute for Neuroscience

    Reno, Nevada, 89502

  • Central Texas Neurology Consultant

    Round Rock, Texas, 78681

  • Oregon Center for Clinical Investigations, Inc.

    Salem, Oregon, 97301

  • Radiant Research, San Antonio Center for Clinical Research

    San Antonio, Texas, 78229

  • Road Runner Research LTD

    San Antonio, Texas, 78258

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078

  • Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology

    Sandy Springs, Georgia, 30328

  • Women's Clinical Research Center

    Seattle, Washington, 98105

  • Kingfisher Cooperative, LLC

    Spokane, Washington, 99202

  • Mercy Research

    Springfield, Missouri, 65806

  • Clinvest

    Springfield, Missouri, 65807

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33713

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Infinity Clinical Research LLC

    Sunrise, Florida, 33351

  • Meridien Research

    Tampa, Florida, 33634

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Diablo Clinical Research Inc

    Walnut Creek, California, 94598

  • Amici Clinical Research

    Warren Township, New Jersey, 07059

  • The George Washington University

    Washington D.C., District of Columbia, 20037

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Medvadis Research Corporation

    Watertown, Massachusetts, 02472

  • ClinPoint Trials, LLC

    Waxahachie, Texas, 75165

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Neurology Research Institute Palm Beach

    West Palm Beach, Florida, 33407

  • Ohio Clinical Research, LLC

    Willoughby Hills, Ohio, 44094

  • New England Regional Headache Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.

Being tested
Atogepant, Placebo-matching Atogepant
Medical subject headings
Migraine Disorders

What participants receive

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

  • AtogepantDrug

    Also called AGN-241689

    Atogepant capsule.

  • Placebo-matching AtogepantDrug

    Placebo-matching atogepant capsule.

Study groups in NCT02848326
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
Receives: Drug: Placebo-matching Atogepant
Atogepant 10 mg QDExperimentalAtogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
Receives: Drug: Atogepant; Drug: Placebo-matching Atogepant
Atogepant 30 mg QDExperimentalAtogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
Receives: Drug: Atogepant; Drug: Placebo-matching Atogepant
Atogepant 30 mg BIDExperimentalAtogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Receives: Drug: Atogepant
Atogepant 60 mg QDExperimentalAtogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
Receives: Drug: Atogepant; Drug: Placebo-matching Atogepant
Atogepant 60 mg BIDExperimentalAtogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Receives: Drug: Atogepant

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 (Migraine/Probable Migraine Headache 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 and acute symptomatic medication use. The 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. Negative change from Baseline indicates improvement.

    Measured: Baseline (First 28 Days of Screening/Baseline Period) to Week 12

Secondary outcomes (3)

  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 and acute symptomatic medication use. The 4-week (monthly) headache days was 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. Negative change from Baseline indicates improvement.

    Measured: Baseline (First 28 Days of Screening/Baseline Period) to Week 12

  2. Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache 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 and acute symptomatic medication use. The 4-week migraine days=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 (First 28 Days of Screening/Baseline Period) to Week 12

  3. 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 4-week (monthly) 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. A negative change from Baseline indicates improvement.

    Measured: Baseline (First 28 Days of Screening/Baseline Period) 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 posted28 Jul 2016 (estimated)
  2. Study start6 Sep 2016
  3. Primary completion2 Apr 2018
  4. Study completion23 Apr 2018

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
834 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02848326
Sponsor's protocol ID
CGP-MD-01
Status last verified
Nov 2018
First submitted
26 Jul 2016
Last updated
6 Dec 2018
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

  • 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

  • Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9.

    PubMed 32822633

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Atogepant in people with Migraine, With or Without Aura, run by Allergan at 75 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 4 inclusion and 8 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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Dec 2018). 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 (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period (time frame: Baseline (First 28 Days of Screening/Baseline Period) 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 NCT02848326, 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 6 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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