Clinical trial NCT03939312: Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Official title: A Phase 3, Multicenter, Open-Label 40-week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: Migraine
Aura
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-05-06
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.


Eligibility criteria: Inclusion Criteria:

* Written informed consent and participant privacy information (eg, written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures.
* Participants must be using a medically acceptable and effective method of birth control during the course of the entire study.
* Eligible participants who completed the double-blind treatment period (Visit 7) and the follow-up period (Visit 8), if applicable, depending on the timing of study initiation, of Study 3101-301-002 (NCT03777059) without significant protocol deviations (eg, noncompliance to protocol-required procedures).

Exclusion Criteria:

* Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1.
* Hypertension as defined by sitting systolic BP \> 160 mm Hg or sitting diastolic BP \> 100 mm Hg at Visit 1.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Primary outcomes:
measure: Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)
timeFrame: From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Secondary outcomes:
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator
timeFrame: Up to Week 44
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator
timeFrame: Up to Week 40
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
timeFrame: Up to Week 44
measure: Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Synexus Clinical Research US, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Alea Research
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
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: 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: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers, Inc
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: 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: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Trials
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 Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
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: 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, 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: 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: Collective 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: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
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: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
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: 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 Neurosciences Research Center
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
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: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Lyndhurst
country: United States
facility: Ohio Clinical Research, LLC
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: Tulsa
country: United States
facility: Tulsa Clinical Research
state: Oklahoma
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, LLC
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: 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: Clinical Neuroscience Solutions, Inc.
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, Inc
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
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: Synexus-US
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
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Neruology Specialists
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: Tacoma
country: United States
facility: Puget Sound Neurology
state: Washington
Study officials:
affiliation: Allergan
name: Joel Trugman, MD
role: STUDY_DIRECTOR
References:
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.