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To Evaluate the Safety and Tolerability of Atogepant 10mg, 30 mg and 60 mg Once a Day for the Prevention of Migraine in Participants With Episodic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03777059
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: Atogepant 30 mg Drug: Atogepant 60 mg Drug: Placebo Drug: Atogepant 10 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 872 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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)
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : February 5, 2020
Estimated Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Atogepant 30 mg
Taken once daily
Drug: Atogepant 30 mg
Tablets containing atogepant 30 mg

Active Comparator: Atogepant 60 mg
Taken once daily
Drug: Atogepant 60 mg
Tablets containing atogepant 60 mg

Placebo Comparator: Placebo
Taken once daily
Drug: Placebo
10 mg, 30 mg and 60 mg tablets containing atogepant-matching placebo

Active Comparator: Atogepant 10 mg
Taken once daily
Drug: Atogepant 10 mg
Tablets containing atogepant 10 mg




Primary Outcome Measures :
  1. Change from baseline in mean monthly migraine days across the 12-week treatment period [ Time Frame: 12 weeks ]
    Baseline is defined as the number of migraine days during the last 28 days of the baseline phase, ie, Day -28 to -1.


Secondary Outcome Measures :
  1. Change from baseline in mean monthly headache days across the 12-week treatment period. [ Time Frame: 12 Weeks ]
    Baseline is defined as the number of migraine days during the last 28 days of the baseline phase, ie, Day -28 to -1.

  2. Change from baseline in mean monthly acute medication use days across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Baseline is defined as the number of acute medication use days during the last 28 days of the baseline phase, ie, Day-28 to -1.

  3. Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. [ Time Frame: 12 weeks ]
    Defined as participants with at least a 50% reduction from baseline in monthly migraine days,

  4. Change from baseline in mean monthly performance of daily activities domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]

    Baseline is defined as the monthly performance of daily activities domain score during the last 28 days of the baseline phase, ie, Day -28 to -1.

    The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Very difficult," "Extremely difficult," and "I could not do it at all."


  5. Change from baseline in mean monthly physical impairment domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]

    Baseline is defined as the monthly physical impairment domain score during the last 28 days of the baseline phase, ie, Day -28 to -1.

    The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Very difficult," "Extremely difficult," and "I could not do it at all."




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 (eg, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777059


Contacts
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Contact: Clinical Trials Registy Team 877-277-8566 IR-CTRegistration@allergan.com

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Locations
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United States, Arizona
Synexus Clinical Research US, Inc. Recruiting
Chandler, Arizona, United States, 85224
Contact    480-782-5552      
Alea Research Institute Recruiting
Phoenix, Arizona, United States, 85012
Contact: Study Coordinator    602-562-7000      
Barrow Neurological Institute Not yet recruiting
Phoenix, Arizona, United States, 85013
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact    602-406-6297      
Orange Grove Family Practice Recruiting
Tucson, Arizona, United States, 85741
Contact: Study Coordinator    520-333-4515      
United States, Arkansas
Principals Research Group Recruiting
Hot Springs, Arkansas, United States, 71901
Contact: Study Coordinator    501-321-0547      
Arkansas Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Study Coordinator    501-907-9169      
Baptist Health Center for Clinical Research Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Study Coordinator    501-224-1348      
United States, California
Med Center Medical Clinic Recruiting
Carmichael, California, United States, 95608
Triwest Research Associates Recruiting
El Cajon, California, United States, 92020
Contact: Study Coordinator    619-334-4734      
Neuro Pain Medical Center Recruiting
Fresno, California, United States, 93710
Contact: Study Coordinator    559-437-9700      
California Headache and Balance Center Recruiting
Fresno, California, United States, 93720
Contact: Study Coordinator    559-435-6492      
Fullerton Neurology and Headache Center Active, not recruiting
Fullerton, California, United States, 92835
Neurology Center of North Orange County Recruiting
Fullerton, California, United States, 92835
Contact: Study Coordinator    714-879-7200      
NervePro Research Bruce Cleeremans Active, not recruiting
Irvine, California, United States, 92618
Torrance Clinical Research Institute, Inc. Recruiting
Lomita, California, United States, 90731
Contact: Study Coordinator    310-373-8120      
Long Beach Clinical Trials Services Recruiting
Long Beach, California, United States, 90806
Contact    562-997-3869      
Keck Medicine of USC Not yet recruiting
Los Angeles, California, United States, 90033
Keck Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Contact    323-442-7678      
Pharmacology Research Institute Recruiting
Newport Beach, California, United States, 92660
Contact: Study Coordinator    949-752-7910      
Newport Beach Clinical Research Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Study Coordinator    949-631-2917      
Stanford Not yet recruiting
Palo Alto, California, United States, 94304
Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: Study Coordinator    650-723-6469      
Rancho Cucamonga Clinical Research Recruiting
Rancho Cucamonga, California, United States, 91730
Contact: Study Coordinator    909-941-3985      
George J. Rederich, M.D. Inc. Recruiting
Redondo Beach, California, United States, 90277
Contact: Study Coordinator    310-376-9492      
Paradigm Clinical Research Centers, Inc Recruiting
San Diego, California, United States, 92117
Contact    530-247-7049      
Optimus Medical Group Recruiting
San Francisco, California, United States, 94102
Contact    415-423-4055      
California Neuroscience Research Recruiting
Sherman Oaks, California, United States, 91403
Contact: Study Coordinator    818-990-2671      
United States, Colorado
Alpine Clinical Research Center Recruiting
Boulder, Colorado, United States, 80301
Contact: Study Coordinator    303-443-7229      
Colorado Springs Neurological Associates Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Study Coordinator    719-473-3272      
Delta Waves, Inc. Active, not recruiting
Colorado Springs, Colorado, United States, 80918
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
Contact: Study Coordinator    720-336-4300      
United States, Connecticut
New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
Contact: Study Coordinator    203-914-1903      
United States, Florida
Aventura Neurological Associates Recruiting
Aventura, Florida, United States, 33180
Neurology Offices of South Florida Active, not recruiting
Boca Raton, Florida, United States, 33428
Sarkis Clinical Trials- Gainesville Recruiting
Gainesville, Florida, United States, 32607
Contact: Study Coordinator    352-333-0094      
Westside Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32205
Contact: Study Coordinator    904-693-1490      
Clinical Neuroscience Solutions, Inc. Recruiting
Jacksonville, Florida, United States, 32256
Contact    904-281-5757      
Neurology Associates, P.A. Recruiting
Maitland, Florida, United States, 32751
Contact: Study Coordinator    407-647-5996      
Clinical Neuroscience Solutions Recruiting
Orlando, Florida, United States, 32801
Contact    407-425-5100      
Neurology Associates of Ormond Beach Recruiting
Ormond Beach, Florida, United States, 32174
Contact: Study Coordinator    386-673-2500 ext 248      
Meridien Research Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Study Coordinator    727-347-8839      
Sarasota Memorial Hospital Clinical Research Center Recruiting
Sarasota, Florida, United States, 34239
Contact: Study Coordinator    941-917-8900      
Axiom Clinical Research of Florida Recruiting
Tampa, Florida, United States, 33609
Contact: Study Coordinator    813-353-9613      
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Study Coordinator    813-974-0979      
United States, Georgia
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology Recruiting
Atlanta, Georgia, United States, 30328
Contact: Study Coordinator    678-705-7341      
Synexus Clinical Research US, Inc. Recruiting
Atlanta, Georgia, United States, 30328
Contact    404-255-6005      
Neurotrials Research Recruiting
Atlanta, Georgia, United States, 30342
Meridian Clinical Research, LLC Recruiting
Savannah, Georgia, United States, 31406
United States, Illinois
Diamond Headache Clinic Ltd Recruiting
Chicago, Illinois, United States, 60642
Contact: Study Coordinator    773-388-6390      
Clinical Investigation Specialists Active, not recruiting
Gurnee, Illinois, United States, 60031
United States, Indiana
JWM Neurology Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Study Coordinator    317-537-6088      
Deaconess Clinic - Gateway Health Center Recruiting
Newburgh, Indiana, United States, 47630
Contact: Study Coordinator    812-492-5011      
United States, Iowa
PMG Research, Inc. d/b/a PMG Research of McFarland Clinic Recruiting
Ames, Iowa, United States, 50010
Contact: Study Coordinator    515-956-4159      
United States, Kansas
Heartland Research Associates, LLC Recruiting
Newton, Kansas, United States, 67114
Contact: Study Coordinator    316-283-2800      
College Park Family Care Center Recruiting
Overland Park, Kansas, United States, 66212
Contact: Study Coordinator    913-469-9887      
Phoenix Medical Research Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Study Coordinator    913-381-7180      
Heartland Research Associates, LLC - An AMR Company Recruiting
Wichita, Kansas, United States, 67205
Contact: Study Coordinator    316-462-0420      
Heartland Research Associates, LLC - An AMR Company Recruiting
Wichita, Kansas, United States, 67207
Contact: Study Coordinator    316-652-0023      
United States, Kentucky
Otrimed Active, not recruiting
Edgewood, Kentucky, United States, 41017
United States, Louisiana
Ochsner Clinic Foundation Recruiting
Covington, Louisiana, United States, 70433
DelRicht Research Recruiting
New Orleans, Louisiana, United States, 70124
Contact: Study Coordinator    504-336-2667      
United States, Maryland
Pharmasite Research, Inc. Recruiting
Baltimore, Maryland, United States, 21208
Contact: Study Coordinator    410-602-1440      
Mid-Atlantic Permanente Medical Group, PC Recruiting
Largo, Maryland, United States, 20774
Contact    301-386-6850      
United States, Massachusetts
John R. Graham Headache Center Brigham and Women's Faulkner Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact    617-732-4699      
BTC of New Bedford Recruiting
New Bedford, Massachusetts, United States, 02740
Contact: Study Coordinator    508-990-9555 ext 610      
United States, Minnesota
Minneapolis Clinic of Neurology Recruiting
Golden Valley, Minnesota, United States, 55422
Contact: Study Coordinator    763-588-0661      
Clinical Research Institute Recruiting
Minneapolis, Minnesota, United States, 55402
Contact    612-333-2200      
United States, Mississippi
Synexus Usa Recruiting
Bay Saint Louis, Mississippi, United States, 63141
Contact: Study Coordinator    314-692-2100      
The Headache Center Recruiting
Ridgeland, Mississippi, United States, 39157
Contact: Study Coordinator    601-594-1319      
United States, Missouri
StudyMetrix Research Recruiting
Saint Peters, Missouri, United States, 63303
Contact: Study Coordinator    636-387-5100      
Clinvest Research LLC. Recruiting
Springfield, Missouri, United States, 65810
Contact: Study Coordinator    314-251-8890      
United States, Nebraska
Synexus Clinical Research US, Inc. Recruiting
Omaha, Nebraska, United States, 68144
Contact    402-205-7998      
United States, Nevada
Nevada Headache Institute Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Study Coordinator    702-749-7147      
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
Contact: Study Coordinator    732-244-2299      
United States, New York
Dent Neurologic Institute Recruiting
Amherst, New York, United States, 14226
Contact    716-250-2000      
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Study Coordinator    929-263-3822      
Northwell Health Recruiting
Great Neck, New York, United States, 11021
Contact: Study Coordinator    516-325-7000      
United States, North Carolina
PMG Research of Charlotte, LLC Recruiting
Charlotte, North Carolina, United States, 28209
Contact: Study Coordinator    704-527-6672      
Guilford Neurologic Associates, Inc Active, not recruiting
Greensboro, North Carolina, United States, 27405
Raleigh Neurology Associates, P.A. Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Study Coordinator    919-782-3456      
PMG Research of Raleigh, LLC Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Study Coordinator    919-783-4895      
PMG Research of Rocky Mount, LLC Recruiting
Rocky Mount, North Carolina, United States, 27804
Wilmington Health, PLLC Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Study Coordinator    910-799-5500      
Piedmont Medical Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Study Coordinator    336-768-8062      
United States, Ohio
Synexus Clinical Research US, Inc. Recruiting
Akron, Ohio, United States, 44311
Contact    330-252-1500      
CTI Clinical Research Center Recruiting
Cincinnati, Ohio, United States, 45212
Contact: Study Coordinator    513-598-9290      
Patient Priority Clinical Sites Recruiting
Cincinnati, Ohio, United States, 45215
Contact: Study Coordinator    513-791-7760      
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Study Coordinator    513-558-4622      
Sentral Clinical Research Services Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Study Coordinator    513-769-2766      
Aventiv Research Inc Recruiting
Columbus, Ohio, United States, 43213
Contact: Study Coordinator    614-501-6164      
Family Physicians Associates Recruiting
Lyndhurst, Ohio, United States, 44124
Contact: Study Coordinator    440-386-4220      
United States, Oklahoma
OK Clinical Research, LLC Recruiting
Edmond, Oklahoma, United States, 73034
Contact: Study Coordinator    405-285-6811      
Lynn Institute of Norman Recruiting
Norman, Oklahoma, United States, 73069
Contact: Study Coordinator    405-701-2466      
Centennial Health-Synexus Recruiting
Oklahoma City, Oklahoma, United States, 73111
Contact: Study Coordinator    405-510-0525      
Tulsa Clinical Research Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Study Coordinator    918-743-2349      
United States, Oregon
Oregon Center for Clinical Investigations Recruiting
Portland, Oregon, United States, 97214
Contact: Study Coordinator    503-276-6224      
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Preferred Primary Care Physicians Recruiting
Pittsburgh, Pennsylvania, United States, 15236
Contact: Study Coordinator    412-650-6156      
Frontier Clinical Research, LLC Recruiting
Smithfield, Pennsylvania, United States, 15478
Contact: Study Coordinator    724-550-4099      
Preferred Primary Care Physicians, Jacob Murphy Recruiting
Uniontown, Pennsylvania, United States, 15401
Contact: Study Coordinator    724-912-0033      
Abington Neurological Associates Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Study Coordinator    215-957-9250      
United States, Rhode Island
Partners in Clinical Research Recruiting
Cumberland, Rhode Island, United States, 02864
Contact    401-658-2305      
Ocean State Clinical Research Partners Recruiting
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Primary Care Associates/Synexus Clinical Recruiting
Anderson, South Carolina, United States, 29621
Synexus Clinical Research US, Inc Recruiting
Anderson, South Carolina, United States, 29621
Contact    864-261-9563      
Clinical Trials of South Carolina Recruiting
Charleston, South Carolina, United States, 29406
Contact: Study Coordinator    843-408-0425      
Hillcrest Family Practice Recruiting
Simpsonville, South Carolina, United States, 29681
Contact: Study Coordinator    864-962-5146      
United States, Tennessee
ClinSearch Recruiting
Chattanooga, Tennessee, United States, 37421
Holston Medical Group Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Study Coordinator    423-578-1546      
CNS Healthcare - Memphis Recruiting
Memphis, Tennessee, United States, 38119
Contact    901-843-1045      
United States, Texas
Psychiatry & Psychotherapy Partners Austin Recruiting
Austin, Texas, United States, 78737
Contact: Study Coordinator    512-898-9362      
Synexus-US Recruiting
Dallas, Texas, United States, 75234
Contact: Study Coordinator    972-241-1222      
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Ventavia Research Group Recruiting
Fort Worth, Texas, United States, 76104
Contact: Study Coordinator    817-348-0228      
Centex Studies, Inc. Recruiting
Houston, Texas, United States, 77058
Contact: Study Coordinator    281-282-0808      
Protenium Clinical Research Recruiting
Hurst, Texas, United States, 76054
Contact: Study Coordinator    817-281-4156      
Clinical Trials of Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-949-0122      
Synexus Clinical Research US, Inc. Recruiting
San Antonio, Texas, United States, 78229
Contact    210-614-7483      
ClinPoint Trials Recruiting
Waxahachie, Texas, United States, 75165
Contact: Study Coordinator    972-937-1640      
United States, Utah
Synexus-US Recruiting
Murray, Utah, United States, 84123
Contact: Study Coordinator    801-261-8930      
J. Lewis Research, Inc. / Foothill Family Clinic South Recruiting
Salt Lake City, Utah, United States, 84121
Highland Clinical Research Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Study Coordinator    801-559-3855      
J. Lewis Research, Inc. Recruiting
South Jordan, Utah, United States, 84095
Contact: Study Coordinator    801-676-8109      
United States, Virginia
Health Research of Hampton Roads, Inc. Recruiting
Newport News, Virginia, United States, 23606
Contact: Study Coordinator    757-591-8100      
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23219
National Clinical Research, Inc Recruiting
Richmond, Virginia, United States, 23294
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact    804-651-2048      
Sentara Family Medicine Physicians Recruiting
Virginia Beach, Virginia, United States, 23456
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Study Coordinator    425-453-0404      
Eastside Therapeutic Resource and Core Clinical Research Recruiting
Everett, Washington, United States, 98201
Contact: Study Coordinator    425-443-9551      
The Polyclinic Recruiting
Seattle, Washington, United States, 98104
Contact: Study Coordinator    206-320-6692      
Puget Sound Neurology Recruiting
Tacoma, Washington, United States, 25328
Sponsors and Collaborators
Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03777059     History of Changes
Other Study ID Numbers: 3101-301-002
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Migraine
Aura
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases