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

November 13, 2018 updated by: Allergan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
834

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Radiant Research, Inc.
    • California
      • Carlsbad, California, United States, 92011
        • The Research Center of Southern California, LLC
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center, Inc
      • Irvine, California, United States, 92618
        • Irvine Center for Clinical Research
      • Los Angeles, California, United States, 90017
        • Downtown LA Research Center, Inc.
      • Oceanside, California, United States, 92056
        • Excell Research
      • San Marcos, California, United States, 92078
        • Artemis Institute for Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research Inc
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Advanced Neurosciences Research
    • Connecticut
      • East Hartford, Connecticut, United States, 06118
        • Hartford Headache Center
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern Connecticut, P. C.
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research South Florida
      • Hollywood, Florida, United States, 33021
        • Infinity Clinical Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions Inc
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Miami, Florida, United States, 33135
        • Suncoast Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Center / Advanced Research Consultants, Inc.
      • Saint Petersburg, Florida, United States, 33713
        • Suncoast Neuroscience Associates, Inc.
      • Sunrise, Florida, United States, 33351
        • Infinity Clinical Research LLC
      • Tampa, Florida, United States, 33634
        • Meridien Research
      • West Palm Beach, Florida, United States, 33407
        • Neurology Research Institute Palm Beach
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Institute for Advanced Medical Research
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30328
        • Radiant Research
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Sandy Springs, Georgia, United States, 30328
        • Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials, Inc.
    • Illinois
      • Blue Island, Illinois, United States, 60406
        • Healthcare Research Network II, LLC
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • Rowe Neurology Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials Inc
      • North Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc.
      • Watertown, Massachusetts, United States, 02472
        • MedVadis Research Corporation
      • Worcester, Massachusetts, United States, 01605
        • New England Regional Headache Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain and Neurological Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute, Inc.
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest
      • Springfield, Missouri, United States, 65806
        • Mercy Research
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, Inc
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research Institute
      • Reno, Nevada, United States, 89502
        • Renown Institute for Neuroscience
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute - NJ
      • Warren, New Jersey, United States, 07059
        • Amici Clinical Research
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center
      • Jamaica, New York, United States, 11432
        • Radiant Research, Inc.
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Carolina Headache Institute
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates Llc
    • Ohio
      • Willoughby Hills, Ohio, United States, 44094
        • Ohio Clinical Research, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Oregon
      • Salem, Oregon, United States, 97301
        • Oregon Center for Clinical Investigations, Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center For Clinical Research
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • CNS Healthcare
      • Nashville, Tennessee, United States, 37203
        • Nashville Neuroscience Group
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch Inc
      • Austin, Texas, United States, 78745
        • Tekton Research
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc.
      • Dallas, Texas, United States, 75234
        • Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology Consultant
      • San Antonio, Texas, United States, 78229
        • Radiant Research, San Antonio Center for Clinical Research
      • San Antonio, Texas, United States, 78258
        • Road Runner Research Ltd
      • Waxahachie, Texas, United States, 75165
        • ClinPoint Trials, LLC
    • Utah
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Tidewater Integrated Medical Research
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98105
        • Women's Clinical Research Center
      • Spokane, Washington, United States, 99202
        • Kingfisher Cooperative, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks.
Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Experimental: Atogepant 10 mg QD
Atogepant 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.
Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Drug: Atogepant
Atogepant capsule.
Other Names:
  • AGN-241689
Experimental: Atogepant 30 mg QD
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Drug: Atogepant
Atogepant capsule.
Other Names:
  • AGN-241689
Experimental: Atogepant 30 mg BID
Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Drug: Atogepant
Atogepant capsule.
Other Names:
  • AGN-241689
Experimental: Atogepant 60 mg QD
Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks.
Drug: Placebo-matching Atogepant
Placebo-matching atogepant capsule.
Drug: Atogepant
Atogepant capsule.
Other Names:
  • AGN-241689
Experimental: Atogepant 60 mg BID
Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks.
Drug: Atogepant
Atogepant capsule.
Other Names:
  • AGN-241689

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline (First 28 Days of Screening/Baseline Period) to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
Time Frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
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.
Baseline (First 28 Days of Screening/Baseline Period) to Week 12
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
Time Frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
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.
Baseline (First 28 Days of Screening/Baseline Period) to Week 12
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
Time Frame: Baseline (First 28 Days of Screening/Baseline Period) to Week 12
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.
Baseline (First 28 Days of Screening/Baseline Period) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CGP-MD-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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