An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
- Conditions
- Migraine, With or Without Aura
- Interventions
- Registration Number
- NCT02873221
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the long-term safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.
- Detailed Description
Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be double-blind for active treatment arms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1254
-Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).
- Patients with clinically significant electrocardiogram (ECG), vital sign, physical exam, or laboratory abnormalities
- Requirement for a medication during the study that is on the list of prohibited medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual Care Usual Care as prescribed by the physician as standard of care in clinical practice for the treatment of migraine attacks for up to 1 year. Ubrogepant 50 mg Placebo-matching Ubrogepant Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns. Ubrogepant 50 mg Ubrogepant Ubrogepant 50 mg tablet orally plus placebo-matching ubrogepant tablet for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns. Ubrogepant 100 mg Ubrogepant Ubrogepant 100 mg (two 50 mg tablets) orally for the treatment of a qualifying migraine attack for up to 8 treatments every 4 weeks for up to 1 year. Participants may choose to take a second dose orally after the initial dose if migraine continues or returns.
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least 1 Treatment Emergent Adverse Event 56 Weeks An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Laboratory Values 56 Weeks Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings 56 Weeks ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants With Clinically Significant Vital Sign Measurements 56 Weeks Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales 56 Weeks On the C-SSRS, the 5 types of suicidal ideation are:
Type 1: "Wish to be dead" Type 2: Non-specific active suicidal thoughts Type 3: "Active suicidal ideation with any methods (not plan) without intent to act" Type 4: "Active suicidal ideation with some intent to act, without specific plan" Type 5: "Active suicidal ideation with specific plan and intent"
Trial Locations
- Locations (170)
Kentucky Pediatric Research Inc
🇺🇸Bardstown, Kentucky, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Aventura Neurological Associates, PA
🇺🇸Aventura, Florida, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Pacific Institute of Medical Research
🇺🇸Los Angeles, California, United States
Radiant Research, Inc.
🇺🇸Dallas, Texas, United States
Michigan Ave. Internists /Radiant Research, Inc.
🇺🇸Chicago, Illinois, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Preferred Primary Care Physicians, Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Boston Clinical Trials Inc
🇺🇸Boston, Massachusetts, United States
Desert Clinical Research /Radiant Research, Inc.
🇺🇸Mesa, Arizona, United States
Radiant Research Inc.
🇺🇸Tucson, Arizona, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Neuro-Pain Medical Center, Inc
🇺🇸Fresno, California, United States
Southern California Research Center
🇺🇸Simi Valley, California, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Axiom Research, LLC
🇺🇸Colton, California, United States
Orange Grove Family Practice/Radiant Research, Inc.
🇺🇸Tucson, Arizona, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Axiom Research
🇺🇸Apple Valley, California, United States
Encino Research Center/T Joseph Raoof MD Inc
🇺🇸Encino, California, United States
Principals Research Group, Inc.
🇺🇸Hot Springs, Arkansas, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Delta Waves, Inc
🇺🇸Colorado Springs, Colorado, United States
Summit Headache and Neurologic Institute
🇺🇸Englewood, Colorado, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Rancho Cucamonga Clinical Research
🇺🇸Rancho Cucamonga, California, United States
Avail Clinical Research
🇺🇸DeLand, Florida, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
Associated Neurologists, PC
🇺🇸Danbury, Connecticut, United States
Broward Research
🇺🇸Hollywood, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
Clinicos LLC
🇺🇸Colorado Springs, Colorado, United States
Newport Beach Clinical Research Associates, Inc.
🇺🇸Newport Beach, California, United States
Associated Neurologists of Southern Connecticut, PC
🇺🇸Fairfield, Connecticut, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
BTC of New Bedford
🇺🇸New Bedford, Massachusetts, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Midtown Neurology
🇺🇸Atlanta, Georgia, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Great Lakes Clinical Trials, LLC
🇺🇸Chicago, Illinois, United States
Neurology Associates, P.A.
🇺🇸Hickory, North Carolina, United States
Qps Mra, Llc
🇺🇸South Miami, Florida, United States
New England Regional Headache Center
🇺🇸Worcester, Massachusetts, United States
Women's Health Care Specialists
🇺🇸Kalamazoo, Michigan, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
Medvadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Aventiv Research Inc.
🇺🇸Columbus, Ohio, United States
New Orleans Center for Clinical Research
🇺🇸Knoxville, Tennessee, United States
Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
DENT Neurosciences Research Center
🇺🇸Amherst, New York, United States
Lake Shore Clinical Research, LLC
🇺🇸Mooresville, North Carolina, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Vista Clinical Research
🇺🇸Columbia, South Carolina, United States
Ohio Clinical Research, LLC
🇺🇸Cleveland, Ohio, United States
Clinical Research Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Plains Clinical Research Center, LLC
🇺🇸Fargo, North Dakota, United States
Research Trials Worldwide, LLC
🇺🇸Humble, Texas, United States
Wake Research Associates LLC
🇺🇸Raleigh, North Carolina, United States
Clinical Research Associates Tidewater
🇺🇸Norfolk, Virginia, United States
Hillcrest Clinical Research LLC
🇺🇸Simpsonville, South Carolina, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
CNS Healthcare
🇺🇸Memphis, Tennessee, United States
South Puget Sound Neurology
🇺🇸Tacoma, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Blue Ridge Research Center
🇺🇸Roanoke, Virginia, United States
Sentara Neurology Specialists
🇺🇸Virginia Beach, Virginia, United States
College Park Family Care Center Physicians Group- Neurology Research Dept
🇺🇸Overland Park, Kansas, United States
Kansas Institute of Research
🇺🇸Overland Park, Kansas, United States
Rowe Neurology Institute
🇺🇸Lenexa, Kansas, United States
Josephson Wallack Munshower Neurology, P.C.
🇺🇸Indianapolis, Indiana, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Sentral Clinical Research Services
🇺🇸Cincinnati, Ohio, United States
Road Runner Research
🇺🇸San Antonio, Texas, United States
Patient Priority Clinical Sites
🇺🇸Cincinnati, Ohio, United States
University of cincinnati
🇺🇸Cincinnati, Ohio, United States
Radiant Research, Inc
🇺🇸Cincinnati, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
NPC Research
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Highland Clinical Reserach
🇺🇸Salt Lake City, Utah, United States
Optimum Clinical Research, Inc.
🇺🇸Salt Lake City, Utah, United States
The Polyclinic
🇺🇸Seattle, Washington, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States
Artemis Institute For Clinical Research
🇺🇸San Diego, California, United States
LCC Medical Research
🇺🇸Miami, Florida, United States
Well Pharma Medical Research
🇺🇸Miami, Florida, United States
Denver Neurological Research
🇺🇸Denver, Colorado, United States
Summit Research Network Inc.
🇺🇸Portland, Oregon, United States
Oregon Center For Clinical Investigations Inc
🇺🇸Portland, Oregon, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Meridien Research
🇺🇸Tampa, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Clinical Research Advantage, Inc/Synexus USA
🇺🇸Omaha, Nebraska, United States
Clinical Neuroscience Solutions Inc
🇺🇸Jacksonville, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Clinical Research Institute, Inc.
🇺🇸Minneapolis, Minnesota, United States
Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States
Grossmont Center For Clinical Research
🇺🇸La Mesa, California, United States
Synergy San Diego
🇺🇸National City, California, United States
George J Rederich MD, Inc.
🇺🇸Redondo Beach, California, United States
California Medical Clinic for Headache
🇺🇸Santa Monica, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Clinical Research South Florida
🇺🇸Coral Gables, Florida, United States
Advanced Neurosciences Research
🇺🇸Fort Collins, Colorado, United States
Infinity Clinical Research
🇺🇸Hollywood, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Palm Beach Neurological Center / Advanced Research Consultants, Inc.
🇺🇸Palm Beach Gardens, Florida, United States
Neurology Research Institute Palm Beach
🇺🇸West Palm Beach, Florida, United States
Deaconess Clinic Inc.
🇺🇸Evansville, Indiana, United States
Robbins Headache Clinic
🇺🇸Riverwoods, Illinois, United States
Northeast Medical Research Associates, Inc.
🇺🇸North Dartmouth, Massachusetts, United States
Seton Medical Group
🇺🇸Baltimore, Maryland, United States
Pharma Site Research
🇺🇸Baltimore, Maryland, United States
Beacon Clinical Research, LLC
🇺🇸Quincy, Massachusetts, United States
Prairie Fields Family Medicine
🇺🇸Fremont, Nebraska, United States
Clinvest
🇺🇸Springfield, Missouri, United States
The Minneapolis Clinic of Neurology, Ltd.
🇺🇸Golden Valley, Minnesota, United States
Diagnostic Center of Medicine - Durango / Radiant Research, Inc.
🇺🇸Las Vegas, Nevada, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Princeton Center for Clinical Research
🇺🇸Skillman, New Jersey, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
Upstate Clinical Research Associates
🇺🇸Williamsville, New York, United States
CTI Clinical research Center
🇺🇸Cincinnati, Ohio, United States
Sooner Clinical Research Inc
🇺🇸Oklahoma City, Oklahoma, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Lincoln Research
🇺🇸Lincoln, Rhode Island, United States
Holston Medical Group, P.C.
🇺🇸Kingsport, Tennessee, United States
Middle Tennessee Clinical Research
🇺🇸Fayetteville, Tennessee, United States
Texas Neurology, P.A.
🇺🇸Dallas, Texas, United States
Red Star Research, LLC
🇺🇸Lake Jackson, Texas, United States
Futuresearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic Draper
🇺🇸Draper, Utah, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Clinical Trials Texas, Inc
🇺🇸San Antonio, Texas, United States
Granger Medical Clinic - Riverton
🇺🇸Riverton, Utah, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
The Headache Center
🇺🇸Ridgeland, Mississippi, United States
Wilks & Safirstein MD PA D/B/A MD Clinical
🇺🇸Hallandale Beach, Florida, United States
East Family Physicians PC/Radiant Research, Inc.
🇺🇸Chandler, Arizona, United States
California Headache and Balance Center
🇺🇸Fresno, California, United States
Med Center Medical Clinic Carmichael
🇺🇸Carmichael, California, United States
Desert Valley Research
🇺🇸Rancho Mirage, California, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Preferred Primary Care Physicians
🇺🇸Uniontown, Pennsylvania, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Future Search Trials
🇺🇸Austin, Texas, United States
Tekton Research
🇺🇸Austin, Texas, United States
Clinical Neuroscience Solutions, Inc - Memphis, TN
🇺🇸Orlando, Florida, United States
Norton Neurology Services
🇺🇸Louisville, Kentucky, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Michigan Head Pain & Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Radiant Research
🇺🇸Anderson, South Carolina, United States