Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
- Registration Number
- NCT03939312
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 685
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atogepant 60 mg Atogepant Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44) An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator Up to Week 40 12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Up to Week 44 PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44 C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Up to Week 44 Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.
Trial Locations
- Locations (107)
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology
🇺🇸Atlanta, Georgia, United States
Preferred Primary Care Physicians
🇺🇸Pittsburgh, Pennsylvania, United States
Neuro Pain Medical Center
🇺🇸Fresno, California, United States
Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Neurology Offices of South Florida
🇺🇸Boca Raton, Florida, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Deaconess Clinic - Gateway Health Center
🇺🇸Newburgh, Indiana, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Synexus Clinical Research, Inc
🇺🇸San Antonio, Texas, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Synexus Clinical Research US, Inc.
🇺🇸Akron, Ohio, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Paradigm Clinical Research Centers, Inc
🇺🇸La Mesa, California, United States
California Headache and Balance Center
🇺🇸Fresno, California, United States
Torrance Clinical Research Institute, Inc.
🇺🇸Lomita, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Long Beach Clinical Trials Services
🇺🇸Long Beach, California, United States
Newport Beach Clinical Research Associates
🇺🇸Newport Beach, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
George J. Rederich, M.D. Inc.
🇺🇸Redondo Beach, California, United States
Rancho Cucamonga Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
California Neuroscience Research
🇺🇸Sherman Oaks, California, United States
Neurotrials Research
🇺🇸Atlanta, Georgia, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Diamond Headache Clinic Ltd
🇺🇸Chicago, Illinois, United States
JWM Neurology
🇺🇸Indianapolis, Indiana, United States
PMG Research, Inc. d/b/a PMG Research of McFarland Clinic
🇺🇸Ames, Iowa, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Raleigh Neurology Associates, P.A.
🇺🇸Raleigh, 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
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Ohio Clinical Research, LLC
🇺🇸Lyndhurst, Ohio, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Tulsa Clinical Research
🇺🇸Tulsa, Oklahoma, United States
Preferred Primary Care Physicians, Jacob Murphy
🇺🇸Uniontown, Pennsylvania, United States
Frontier Clinical Research, LLC
🇺🇸Smithfield, Pennsylvania, United States
Abington Neurological Associates
🇺🇸Willow Grove, Pennsylvania, United States
Ocean State Clinical Research Partners
🇺🇸Lincoln, Rhode Island, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Ventavia Research Group
🇺🇸Fort Worth, Texas, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Puget Sound Neurology
🇺🇸Tacoma, Washington, United States
Sentara Neruology Specialists
🇺🇸Virginia Beach, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Heartland Research Associates, LLC
🇺🇸Newton, Kansas, United States
Collective Medical Research
🇺🇸Prairie Village, Kansas, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Optimus Medical Group
🇺🇸San Francisco, California, United States
Synexus-US
🇺🇸Salt Lake City, Utah, United States
Med Center Medical Clinic
🇺🇸Carmichael, California, United States
Alea Research
🇺🇸Phoenix, Arizona, United States
Desert Valley Research
🇺🇸Redlands, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Sarasota Memorial Hospital Clinical Research Center
🇺🇸Sarasota, Florida, United States
College Park Family Care Center
🇺🇸Overland Park, Kansas, United States
John R. Graham Headache Center Brigham and Women's Faulkner Hospital
🇺🇸Boston, Massachusetts, United States
BTC of New Bedford
🇺🇸New Bedford, Massachusetts, United States
The Headache Center
🇺🇸Ridgeland, Mississippi, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
OK Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Highland Clinical Research
🇺🇸Salt Lake City, Utah, United States
Health Research of Hampton Roads
🇺🇸Newport News, Virginia, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Eastside Therapeutic Resource and Core Clinical Research
🇺🇸Everett, Washington, United States
Primary Care Associates/Synexus Clinical
🇺🇸Anderson, South Carolina, United States
Well Pharma Medical Research, Corp
🇺🇸Miami, Florida, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Aventura Neurological Associates
🇺🇸Aventura, Florida, United States
Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Principals Research Group
🇺🇸Hot Springs, Arkansas, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc.
🇺🇸South Jordan, Utah, United States
Clinical Neuroscience Solutions
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Sarkis Clinical Trials- Gainesville
🇺🇸Gainesville, Florida, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Heartland Research Associates, LLC - An AMR Company
🇺🇸Wichita, Kansas, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Piedmont Medical Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Psychiatry & Psychotherapy Partners Austin
🇺🇸Austin, Texas, United States
Tekton Research
🇺🇸Austin, Texas, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
Partners in Clinical Research, LLC
🇺🇸Cumberland, Rhode Island, United States
Hillcrest Family Practice
🇺🇸Simpsonville, South Carolina, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States