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Episodic MigrainePhase 3NCT03700320

Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily 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 112 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 safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year. 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
744 participants
Where
112 sitesUnited States
Study dates
8 Oct 2018to 21 May 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

  • Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
  • Participant is a candidate to be prescribed at least one of the protocol-defined acceptable oral SOC migraine prevention medications and the participant is willing to accept SOC treatment.
  • Participants must be using a medically acceptable and effective method of birth control during the course of the entire study,
  • 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
  • History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1

Who cannot join

  • Difficulty distinguishing migraine headaches from tension-type or other headaches
  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
  • Has a current diagnosis of chronic migraine (CM), new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy
  • ≥ 15 headache days per month on average across the 3 months prior to Visit 1
  • Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (e.g., aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline period. For all participants, barbiturates are excluded 30 days prior to screening and during the baseline period. For participants randomized to atogepant, barbiturates are excluded through the duration of the study as well
  • 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
Show all 10Show fewer
  • Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal (GI), or neurologic disease
  • Hypertension as defined by sitting systolic blood pressure (BP) > 160 millimeter of mercury (mm Hg) or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2. Vital sign measurements that exceed these limits may be repeated only once.
  • At Visit 1, a user of recreational or illicit drugs or has had a history within the past year of drug or alcohol abuse or dependence
  • History of any GI prior procedures or GI conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of atogepant; participants with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed are not excluded.

Trial locations and contacts

112 sites in 1 country.

112 sites in 1 country

United States112 sites

  • Synexus Clinical Research US, Inc.

    Akron, Ohio, 44311

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Dent Neurosciences Research Center

    Amherst, New York, 14226

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Radiant Research, Inc.

    Anderson, South Carolina, 29621

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Synexus Clinical Research US, Inc.

    Atlanta, Georgia, 30328

  • Atlanta Center for Clinical Research

    Atlanta, Georgia, 30331

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Tekton Research, Inc

    Austin, Texas, 78745

  • Kentucky Pediatric Research

    Bardstown, Kentucky, 40004

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Hassman Research Institutes

    Berlin, New Jersey, 08009

  • Clinical Research Advantage, Inc./Simon Williamson Clinic, PC

    Birmingham, Alabama, 35211

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • DiscoveResearch, Inc.

    Bryan, Texas, 77802

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Synexus Clinical Research US, Inc./East Valley Family Physicians PLC

    Chandler, Arizona, 85224

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • Synexus Clinical Research US, Inc.

    Cincinnati, Ohio, 45236

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Delta Waves, Inc.

    Colorado Springs, Colorado, 80918

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Meridian Clinical Research, LLC

    Dakota Dunes, South Dakota, 57049

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • iResearch Atlanta

    Decatur, Georgia, 30030

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

    Draper, Utah, 84020

  • Pharmacology Research Institute

    Encino, California, 91316

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Evanston Premier Healthcare Research LLC

    Evanston, Illinois, 60201

  • Plains Clinical Medical Clinic, LLC

    Fargo, North Dakota, 58104

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado, 80528

  • MD Clinical

    Hallandale, Florida, 33009

  • Infinity Clinical Research

    Hollywood, Florida, 33024

  • Earle Research

    Houston, Texas, 77058

  • Research Trials WorldWide, LLC

    Humble, Texas, 77338

  • Sun Valley Research Center, Inc.

    Imperial, California, 92251

  • Irvine Center for Clinical Research

    Irvine, California, 92614

  • Clinical Neuroscience Solutions

    Jacksonville, Florida, 32256

  • Synexus Clinical Research US, Inc.

    Jamaica, New York, 11432

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Grossmont Center for Clinical Research

    La Mesa, California, 91942

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Synergy San Diego

    Lemon Grove, California, 91945

  • MidAmerica Neuroscience Research Foundation dba Rowe Neurology Institute

    Lenexa, Kansas, 66214

  • Collaborative Neuroscience Network, LLC.

    Long Beach, California, 90806

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • SSM Dean Health Research

    Madison, Wisconsin, 53715

  • Meridien Research

    Maitland, Florida, 32751

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Community Clinical Research Network

    Marlborough, Massachusetts, 01752

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • CNS Healthcare - Memphis

    Memphis, Tennessee, 38119

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Synexus Clinical Research US, Inc./Desert Clinical Research, LLC

    Mesa, Arizona, 85213

  • Well Pharma Medical Research, Corp.

    Miami, Florida, 33173

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska, 68701

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • Excell Research, Inc.

    Oceanside, California, 92056

  • Sensible Healthcare LLC

    Ocoee, Florida, 34761

  • Advanced Research Institute

    Ogden, Utah, 84403

  • IPS Research Company

    Oklahoma City, Oklahoma, 73106

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Synexus Clinical Research US, Inc

    Omaha, Nebraska, 68144

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida, 32801

  • Bioclinica Research

    Orlando, Florida, 32806

  • Kansas Institute of Research

    Overland Park, Kansas, 66211

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC

    Phoenix, Arizona, 85020

  • Summit Research Network

    Portland, Oregon, 97210

  • Phoenix Medical Research, Inc.

    Prairie Village, Kansas, 66208

  • Amici Clinical Research

    Raritan, New Jersey, 08869

  • Desert Valley Research

    Redlands, California, 92374

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Oregon Center for Clinical Investigations, Inc.

    Salem, Oregon, 97301

  • Synexus Clinical Research US, Inc.

    San Antonio, Texas, 78229

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • California Research Foundation

    San Diego, California, 92123-1881

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683

  • Seattle Women's: Health, Research

    Seattle, Washington, 98105

  • Princeton Center for Clinical Research

    Skillman, New Jersey, 08558

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • ClinVest

    Springfield, Missouri, 65810

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Infinity Clinical Research LLC

    Sunrise, Florida, 33351

  • Meridien Research

    Tampa, Florida, 33634

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Trinity Clinical Research

    Tullahoma, Tennessee, 37388

  • Tidewater Integrated Medical Research

    Virginia Beach, Virginia, 23454

  • Synexus Clinical Research US, Inc.

    Vista, California, 92083

  • Diablo Clinical Research, Inc

    Walnut Creek, California, 94598

  • ClinPoint Trials

    Waxahachie, Texas, 75165

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York, 14221

  • Ohio Clinical Research, LLC

    Willoughby Hills, Ohio, 44094

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Open-label Study to Evaluate the Long-term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.

Being tested
Standard of Care (SOC) Migraine Preventive Medication, Atogepant

What participants receive

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

  • Standard of Care (SOC) Migraine Preventive MedicationDrug

    Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.

  • AtogepantDrug

    Atogepant tablets taken orally, once daily for 52 weeks.

Study groups in NCT03700320
Study groupRoleWhat they receive
Oral SOC Migraine Preventive MedicationActive comparatorOral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
Receives: Drug: Standard of Care (SOC) Migraine Preventive Medication
Atogepant 60 mgExperimentalAtogepant 60 mg tablet taken orally, once daily for 52 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 (TEAE)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.

    Measured: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

Secondary outcomes (4)

  1. Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator

    Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.

    Measured: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

  2. Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator

    A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.

    Measured: Up to Week 52

  3. Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator

    Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.

    Measured: From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)

  4. Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior

    The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.

    Measured: Up to Week 52

Timeline

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

  1. First posted9 Oct 2018
  2. Study start8 Oct 2018
  3. Primary completion21 May 2020
  4. Study completion21 May 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
744 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03700320
Sponsor's protocol ID
3101-302-002
Status last verified
May 2021
First submitted
25 Sep 2018
Last updated
15 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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

  • 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, Halker Singh RB, Mechtler L, McVige J, Ma J, Yu SY, Stokes J, Dabruzzo B, Gandhi P, Ashina M. Patient-reported migraine-specific quality of life, activity impairment and headache impact with once-daily atogepant for preventive treatment of migraine in a randomized, 52-week trial. Cephalalgia. 2023 Aug;51(8):3331024231190296. doi: 10.1177/03331024231190296.

    PubMed 37638400

  • 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 112 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 6 inclusion and 10 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 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 15 Jun 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?

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) (time frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up). 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 NCT03700320, which also lists 6 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 15 Jun 2021.

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