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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

834

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

September 6, 2016

Primary Completion (Actual)

April 2, 2018

Study Completion (Actual)

April 23, 2018

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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