12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

Episodic Migraine Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777059
• Other study ID #: 3101-301-002
• Status: Completed
• Phase: Phase 3
• Start date: December 14, 2018
• Est. completion date: June 19, 2020

Study information

• Verified date: June 2021
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 910
• Est. completion date: June 19, 2020
• Est. primary completion date: June 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Atogepant tablet
• Placebo
Placebo-matching atogepant tablets

Locations

Country	Name	City	State
United States	Synexus Clinical Research US, Inc.	Akron	Ohio
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	PMG Research, Inc. d/b/a PMG Research of McFarland Clinic	Ames	Iowa
United States	Dent Neurologic Institute	Amherst	New York
United States	Primary Care Associates/Synexus Clinical	Anderson	South Carolina
United States	Synexus Clinical Research US, Inc	Anderson	South Carolina
United States	Neurotrials Research	Atlanta	Georgia
United States	Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology	Atlanta	Georgia
United States	Synexus Clinical Research US, Inc.	Atlanta	Georgia
United States	Psychiatry & Psychotherapy Partners Austin	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Aventura Neurological Associates	Aventura	Florida
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Synexus Usa	Bay Saint Louis	Mississippi
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Neurology Offices of South Florida	Boca Raton	Florida
United States	John R. Graham Headache Center Brigham and Women's Faulkner Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Med Center Medical Clinic	Carmichael	California
United States	Synexus Clinical Research US, Inc.	Chandler	Arizona
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	ClinSearch	Chattanooga	Tennessee
United States	Diamond Headache Clinic Ltd	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Patient Priority Clinical Sites	Cincinnati	Ohio
United States	Sentral Clinical Research Services	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Delta Waves, Inc.	Colorado Springs	Colorado
United States	Aventiv Research Inc	Columbus	Ohio
United States	Ochsner Clinic Foundation	Covington	Louisiana
United States	Partners in Clinical Research	Cumberland	Rhode Island
United States	Synexus-US	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	OK Clinical Research, LLC	Edmond	Oklahoma
United States	Triwest Research Associates	El Cajon	California
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Eastside Therapeutic Resource and Core Clinical Research	Everett	Washington
United States	Ventavia Research Group	Fort Worth	Texas
United States	California Headache and Balance Center	Fresno	California
United States	Neuro Pain Medical Center	Fresno	California
United States	Fullerton Neurology and Headache Center	Fullerton	California
United States	Neurology Center of North Orange County	Fullerton	California
United States	Sarkis Clinical Trials- Gainesville	Gainesville	Florida
United States	Advanced Research Associates	Glendale	Arizona
United States	Minneapolis Clinic of Neurology	Golden Valley	Minnesota
United States	Northwell Health	Great Neck	New York
United States	Guilford Neurologic Associates, Inc	Greensboro	North Carolina
United States	Clinical Investigation Specialists	Gurnee	Illinois
United States	Principals Research Group	Hot Springs	Arkansas
United States	Centex Studies, Inc.	Houston	Texas
United States	Protenium Clinical Research	Hurst	Texas
United States	JWM Neurology	Indianapolis	Indiana
United States	NervePro Research Bruce Cleeremans	Irvine	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Mid-Atlantic Permanente Medical Group, PC	Largo	Maryland
United States	Nevada Headache Institute	Las Vegas	Nevada
United States	Ocean State Clinical Research Partners	Lincoln	Rhode Island
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Torrance Clinical Research Institute, Inc.	Lomita	California
United States	Long Beach Clinical Trials Services	Long Beach	California
United States	Keck Medicine of USC	Los Angeles	California
United States	Family Physicians Associates	Lyndhurst	Ohio
United States	Neurology Associates, P.A.	Maitland	Florida
United States	CNS Healthcare - Memphis	Memphis	Tennessee
United States	Well Pharma Medical Research, Corp.	Miami	Florida
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Synexus-US	Murray	Utah
United States	BTC of New Bedford	New Bedford	Massachusetts
United States	DelRicht Research	New Orleans	Louisiana
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Deaconess Clinic - Gateway Health Center	Newburgh	Indiana
United States	Newport Beach Clinical Research Associates	Newport Beach	California
United States	Pharmacology Research Institute	Newport Beach	California
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Excell Research, Inc.	Oceanside	California
United States	Centennial Health-Synexus	Oklahoma City	Oklahoma
United States	Synexus Clinical Research US, Inc.	Omaha	Nebraska
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	College Park Family Care Center	Overland Park	Kansas
United States	Stanford	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Alea Research Institute	Phoenix	Arizona
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	Preferred Primary Care Physicians	Pittsburgh	Pennsylvania
United States	Oregon Center for Clinical Investigations	Portland	Oregon
United States	Phoenix Medical Research	Prairie Village	Kansas
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina
United States	Rancho Cucamonga Clinical Research	Rancho Cucamonga	California
United States	Desert Valley Research	Redlands	California
United States	George J. Rederich, M.D. Inc.	Redondo Beach	California
United States	National Clinical Research, Inc	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	The Headache Center	Ridgeland	Mississippi
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Highland Clinical Research	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Synexus Clinical Research US, Inc.	San Antonio	Texas
United States	Paradigm Clinical Research Centers, Inc	San Diego	California
United States	Optimus Medical Group	San Francisco	California
United States	Sarasota Memorial Hospital Clinical Research Center	Sarasota	Florida
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	The Polyclinic	Seattle	Washington
United States	California Neuroscience Research	Sherman Oaks	California
United States	Hillcrest Family Practice	Simpsonville	South Carolina
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	J. Lewis Research, Inc.	South Jordan	Utah
United States	Clinvest Research LLC.	Springfield	Missouri
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	Puget Sound Neurology	Tacoma	Washington
United States	Axiom Clinical Research of Florida	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Orange Grove Family Practice	Tucson	Arizona
United States	Tulsa Clinical Research	Tulsa	Oklahoma
United States	Preferred Primary Care Physicians, Jacob Murphy	Uniontown	Pennsylvania
United States	Sentara Family Medicine Physicians	Virginia Beach	Virginia
United States	Synexus Clinical Research US, Inc.	Vista	California
United States	ClinPoint Trials	Waxahachie	Texas
United States	Heartland Research Associates, LLC - An AMR Company	Wichita	Kansas
United States	Heartland Research Associates, LLC - An AMR Company	Wichita	Kansas
United States	Abington Neurological Associates	Willow Grove	Pennsylvania
United States	Wilmington Health, PLLC	Wilmington	North Carolina
United States	Piedmont Medical Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period	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.	Baseline (Day -28 to Day -1) to Week 12
Secondary	Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period	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.	Baseline (Day-28 to Day -1) to Week 12
Secondary	Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period	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.	Baseline (Day-28 to Day -1) to Week 12
Secondary	Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days	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.	Baseline (Day -28 to Day -1) to Week 12
Secondary	Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at 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.	Baseline (Day 1) to Week 12
Secondary	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	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.	Baseline (Day -28 to Day -1) to Week 12
Secondary	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	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.	Baseline (Day -28 to Day -1) to Week 12