Clinical trial NCT03777059: 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: Migraine
Aura
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2018-12-17
Enrollment: 910
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 (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.

Primary outcomes:
measure: Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period
timeFrame: Baseline (Day -28 to Day -1) to Week 12
Secondary outcomes:
measure: Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period
timeFrame: Baseline (Day-28 to Day -1) to Week 12
measure: Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period
timeFrame: Baseline (Day-28 to Day -1) to Week 12
measure: Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days
timeFrame: Baseline (Day -28 to Day -1) to Week 12
measure: Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12
timeFrame: Baseline (Day 1) to Week 12
measure: 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
timeFrame: Baseline (Day -28 to Day -1) to Week 12
measure: 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
timeFrame: Baseline (Day -28 to Day -1) to Week 12
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Synexus Clinical Research US, Inc.
state: Arizona
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Phoenix
country: United States
facility: Alea Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice
state: Arizona
city: Hot Springs
country: United States
facility: Principals Research Group
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Carmichael
country: United States
facility: Med Center Medical Clinic
state: California
city: El Cajon
country: United States
facility: Triwest Research Associates
state: California
city: Fresno
country: United States
facility: Neuro Pain Medical Center
state: California
city: Fresno
country: United States
facility: California Headache and Balance Center
state: California
city: Fullerton
country: United States
facility: Fullerton Neurology and Headache Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Irvine
country: United States
facility: NervePro Research Bruce Cleeremans
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute, Inc.
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services
state: California
city: Los Angeles
country: United States
facility: Keck Medicine of USC
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: Redlands
country: United States
facility: Desert Valley Research
state: California
city: Redondo Beach
country: United States
facility: George J. Rederich, M.D. Inc.
state: California
city: San Diego
country: United States
facility: Paradigm Clinical Research Centers, Inc
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Vista
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Delta Waves, Inc.
state: Colorado
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Aventura
country: United States
facility: Aventura Neurological Associates
state: Florida
city: Boca Raton
country: United States
facility: Neurology Offices of South Florida
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials- Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, P.A.
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research, Corp.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research
state: Georgia
city: Atlanta
country: United States
facility: Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
state: Georgia
city: Atlanta
country: United States
facility: Synexus Clinical Research US, Inc.
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Chicago
country: United States
facility: Diamond Headache Clinic Ltd
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists
state: Illinois
city: Indianapolis
country: United States
facility: JWM Neurology
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic - Gateway Health Center
state: Indiana
city: Ames
country: United States
facility: PMG Research, Inc. d/b/a PMG Research of McFarland Clinic
state: Iowa
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Prairie Village
country: United States
facility: Phoenix Medical Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC - An AMR Company
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC - An AMR Company
state: Kansas
city: Covington
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Largo
country: United States
facility: Mid-Atlantic Permanente Medical Group, PC
state: Maryland
city: Boston
country: United States
facility: John R. Graham Headache Center Brigham and Women's Faulkner Hospital
state: Massachusetts
city: New Bedford
country: United States
facility: BTC of New Bedford
state: Massachusetts
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Bay Saint Louis
country: United States
facility: Synexus Usa
state: Mississippi
city: Ridgeland
country: United States
facility: The Headache Center
state: Mississippi
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC.
state: Missouri
city: Omaha
country: United States
facility: Synexus Clinical Research US, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Nevada Headache Institute
state: Nevada
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associates, Inc
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research of Winston-Salem
state: North Carolina
city: Akron
country: United States
facility: Synexus Clinical Research US, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Sentral Clinical Research Services
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Lyndhurst
country: United States
facility: Family Physicians Associates
state: Ohio
city: Edmond
country: United States
facility: OK Clinical Research, LLC
state: Oklahoma
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Centennial Health-Synexus
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians, Jacob Murphy
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Lincoln
country: United States
facility: Ocean State Clinical Research Partners
state: Rhode Island
city: Anderson
country: United States
facility: Primary Care Associates/Synexus Clinical
state: South Carolina
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc
state: South Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Family Practice
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: CNS Healthcare - Memphis
state: Tennessee
city: Austin
country: United States
facility: Psychiatry & Psychotherapy Partners Austin
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Dallas
country: United States
facility: Synexus-US
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research US, Inc.
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
city: Murray
country: United States
facility: Synexus-US
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Family Medicine Physicians
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Everett
country: United States
facility: Eastside Therapeutic Resource and Core Clinical Research
state: Washington
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
city: Tacoma
country: United States
facility: Puget Sound Neurology
state: Washington
Study officials:
affiliation: Allergan
name: Joel Trugman, MD
role: STUDY_DIRECTOR
References:
citation: Lipton RB, Pozo-Rosich P, Blumenfeld AM, Li Y, Severt L, Stokes JT, Creutz L, Gandhi P, Dodick D. Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial. Neurology. 2023 Feb 21;100(8):e764-e777. doi: 10.1212/WNL.0000000000201568. Epub 2022 Nov 17.
citation: Lipton RB, Pozo-Rosich P, Blumenfeld AM, Dodick DW, McAllister P, Li Y, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Rates of Response to Atogepant for Migraine Prophylaxis Among Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2215499. doi: 10.1001/jamanetworkopen.2022.15499.
citation: Schwedt TJ, Lipton RB, Ailani J, Silberstein SD, Tassorelli C, Guo H, Lu K, Dabruzzo B, Miceli R, Severt L, Finnegan M, Trugman JM. Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. Cephalalgia. 2022 Jan;42(1):3-11. doi: 10.1177/03331024211042385. Epub 2021 Sep 14.
citation: Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, Finnegan M, Trugman JM; ADVANCE Study Group. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706. doi: 10.1056/NEJMoa2035908.
citation: 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.
citation: 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.