12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
- Registration Number
- NCT03777059
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 910
- 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.
- 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 (e.g., 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo-matching atogepant tablets orally once daily for 12 weeks. Atogepant 30 mg Placebo Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. Atogepant 30 mg Atogepant Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. Atogepant 60 mg Placebo Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. Atogepant 10 mg Atogepant Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. Atogepant 10 mg Placebo Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks. Atogepant 60 mg Atogepant Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period Baseline (Day -28 to Day -1) 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 or acute symptomatic medication use. The monthly (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. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period Baseline (Day-28 to Day -1) 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 or acute symptomatic medication use. The monthly (4-week) headache days were 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. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. MMRM was used for analysis.
Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period Baseline (Day-28 to Day -1) to Week 12 Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The monthly (4-week) 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. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.
Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days Baseline (Day -28 to Day -1) 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 or acute symptomatic medication use. The monthly (4-week) migraine days is equal to 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.
Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 Baseline (Day 1) to Week 12 MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period Baseline (Day -28 to Day -1) to Week 12 The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) performance of daily activities domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period Baseline (Day -28 to Day -1) to Week 12 The AIM-D is a 9-item PRO measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). Baseline was defined as the monthly (averaged for a month) physical impairment domain score during the last 28 days of the Baseline period from Day -28 to -1. MMRM was used for the analysis.
Trial Locations
- Locations (130)
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Principals Research Group
🇺🇸Hot Springs, Arkansas, United States
Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Hillcrest Family Practice
🇺🇸Simpsonville, South Carolina, United States
John R. Graham Headache Center Brigham and Women's Faulkner Hospital
🇺🇸Boston, Massachusetts, United States
Preferred Primary Care Physicians
🇺🇸Pittsburgh, Pennsylvania, United States
Well Pharma Medical Research, Corp.
🇺🇸Miami, Florida, United States
Nevada Headache Institute
🇺🇸Las Vegas, Nevada, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
The Polyclinic
🇺🇸Seattle, Washington, United States
California Headache and Balance Center
🇺🇸Fresno, California, United States
Keck Medicine of USC
🇺🇸Los Angeles, California, United States
Long Beach Clinical Trials Services
🇺🇸Long Beach, California, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Aventura Neurological Associates
🇺🇸Aventura, Florida, United States
Sarasota Memorial Hospital Clinical Research Center
🇺🇸Sarasota, Florida, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Mid-Atlantic Permanente Medical Group, PC
🇺🇸Largo, Maryland, United States
Clinvest Research LLC.
🇺🇸Springfield, Missouri, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Northwell Health
🇺🇸Great Neck, New York, United States
Guilford Neurologic Associates, Inc
🇺🇸Greensboro, North Carolina, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
Wilmington Health, PLLC
🇺🇸Wilmington, North Carolina, United States
Patient Priority Clinical Sites
🇺🇸Cincinnati, Ohio, United States
Sentral Clinical Research Services
🇺🇸Cincinnati, Ohio, United States
Family Physicians Associates
🇺🇸Lyndhurst, Ohio, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
OK Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Frontier Clinical Research, LLC
🇺🇸Smithfield, Pennsylvania, United States
Preferred Primary Care Physicians, Jacob Murphy
🇺🇸Uniontown, Pennsylvania, United States
Abington Neurological Associates
🇺🇸Willow Grove, Pennsylvania, United States
Partners in Clinical Research
🇺🇸Cumberland, Rhode Island, United States
Ocean State Clinical Research Partners
🇺🇸Lincoln, Rhode Island, United States
Synexus Clinical Research US, Inc
🇺🇸Anderson, South Carolina, United States
Primary Care Associates/Synexus Clinical
🇺🇸Anderson, South Carolina, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
CNS Healthcare - Memphis
🇺🇸Memphis, Tennessee, United States
Synexus-US
🇺🇸Murray, Utah, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Ventavia Research Group
🇺🇸Fort Worth, Texas, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Sentara Family Medicine Physicians
🇺🇸Virginia Beach, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Puget Sound Neurology
🇺🇸Tacoma, Washington, United States
Synexus Clinical Research US, Inc.
🇺🇸San Antonio, Texas, United States
Alea Research Institute
🇺🇸Phoenix, Arizona, United States
Paradigm Clinical Research Centers, Inc
🇺🇸San Diego, California, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Centennial Health-Synexus
🇺🇸Oklahoma City, Oklahoma, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Oregon Center for Clinical Investigations
🇺🇸Portland, Oregon, United States
Diamond Headache Clinic Ltd
🇺🇸Chicago, Illinois, United States
Neurotrials Research
🇺🇸Atlanta, Georgia, United States
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
🇺🇸Atlanta, Georgia, United States
College Park Family Care Center
🇺🇸Overland Park, Kansas, United States
Clinical Investigation Specialists
🇺🇸Gurnee, Illinois, United States
JWM Neurology
🇺🇸Indianapolis, Indiana, United States
Deaconess Clinic - Gateway Health Center
🇺🇸Newburgh, Indiana, United States
Heartland Research Associates, LLC - An AMR Company
🇺🇸Wichita, Kansas, United States
Phoenix Medical Research
🇺🇸Prairie Village, Kansas, United States
PMG Research, Inc. d/b/a PMG Research of McFarland Clinic
🇺🇸Ames, Iowa, United States
Heartland Research Associates, LLC
🇺🇸Newton, Kansas, United States
Ochsner Clinic Foundation
🇺🇸Covington, Louisiana, United States
Synexus Usa
🇺🇸Bay Saint Louis, Mississippi, United States
BTC of New Bedford
🇺🇸New Bedford, Massachusetts, United States
The Headache Center
🇺🇸Ridgeland, Mississippi, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Raleigh Neurology Associates, P.A.
🇺🇸Raleigh, North Carolina, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Eastside Therapeutic Resource and Core Clinical Research
🇺🇸Everett, Washington, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Newport Beach Clinical Research Associates
🇺🇸Newport Beach, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
Torrance Clinical Research Institute, Inc.
🇺🇸Lomita, California, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
NervePro Research Bruce Cleeremans
🇺🇸Irvine, California, United States
Stanford
🇺🇸Palo Alto, California, United States
Delta Waves, Inc.
🇺🇸Colorado Springs, Colorado, United States
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
George J. Rederich, M.D. Inc.
🇺🇸Redondo Beach, California, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Triwest Research Associates
🇺🇸El Cajon, California, United States
Neuro Pain Medical Center
🇺🇸Fresno, California, United States
Med Center Medical Clinic
🇺🇸Carmichael, California, United States
Fullerton Neurology and Headache Center
🇺🇸Fullerton, California, United States
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Neurology Associates, P.A.
🇺🇸Maitland, Florida, United States
Neurology Offices of South Florida
🇺🇸Boca Raton, Florida, United States
Rancho Cucamonga Clinical Research
🇺🇸Rancho Cucamonga, California, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
J. Lewis Research, Inc.
🇺🇸South Jordan, Utah, United States
Tulsa Clinical Research
🇺🇸Tulsa, Oklahoma, United States
Desert Valley Research
🇺🇸Redlands, California, United States
Minneapolis Clinic of Neurology
🇺🇸Golden Valley, Minnesota, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Piedmont Medical Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Psychiatry & Psychotherapy Partners Austin
🇺🇸Austin, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
Tekton Research
🇺🇸Austin, Texas, United States
Sarkis Clinical Trials- Gainesville
🇺🇸Gainesville, Florida, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States