An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
A Multicenter, Randomized, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura
1 other identifier
interventional
1,254
1 country
177
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2016
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 19, 2016
CompletedStudy Start
First participant enrolled
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2018
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedAugust 28, 2019
August 1, 2019
1.9 years
August 16, 2016
August 2, 2019
August 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event
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.
56 Weeks
Secondary Outcomes (4)
Number of Participants With Clinically Significant Laboratory Values
56 Weeks
Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings
56 Weeks
Number of Participants With Clinically Significant Vital Sign Measurements
56 Weeks
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales
56 Weeks
Study Arms (3)
Usual Care
ACTIVE COMPARATORUsual 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
EXPERIMENTALUbrogepant 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
EXPERIMENTALUbrogepant 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.
Interventions
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Eligibility Criteria
You may qualify if:
- Completed study UBR-MD-01(NCT02828020) or UBR-MD-02(NCT02867709).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (177)
Radiant Research, Inc.
Birmingham, Alabama, 35211, United States
East Family Physicians PC/Radiant Research, Inc.
Chandler, Arizona, 85224, United States
Desert Clinical Research /Radiant Research, Inc.
Mesa, Arizona, 85213, United States
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Radiant Research Inc.
Tucson, Arizona, 85712, United States
Orange Grove Family Practice/Radiant Research, Inc.
Tucson, Arizona, 85741, United States
Principals Research Group, Inc.
Hot Springs, Arkansas, 71901, United States
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Axiom Research
Apple Valley, California, 92307, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Med Center Medical Clinic Carmichael
Carmichael, California, 95608, United States
Axiom Research, LLC
Colton, California, 92324, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Encino Research Center/T Joseph Raoof MD Inc
Encino, California, 91436, United States
Neuro-Pain Medical Center, Inc
Fresno, California, 93710, United States
California Headache and Balance Center
Fresno, California, 93720, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Grossmont Center For Clinical Research
La Mesa, California, 91942, United States
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806, United States
Pharmacology Research Institute
Los Alamitos, California, 90270, United States
Pacific Institute of Medical Research
Los Angeles, California, 90024, United States
Synergy San Diego
National City, California, 91950, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, 91730, United States
Desert Valley Research
Rancho Mirage, California, 92270, United States
George J Rederich MD, Inc.
Redondo Beach, California, 90277, United States
Artemis Institute For Clinical Research
San Diego, California, 92103, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
California Medical Clinic for Headache
Santa Monica, California, 90404, United States
Southern California Research Center
Simi Valley, California, 93065, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Radiant Research
Vista, California, 92083, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Clinicos LLC
Colorado Springs, Colorado, 80904, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Delta Waves, Inc
Colorado Springs, Colorado, 80918, United States
Denver Neurological Research
Denver, Colorado, 80210, United States
Summit Headache and Neurologic Institute
Englewood, Colorado, 80113, United States
Advanced Neurosciences Research
Fort Collins, Colorado, 80528, United States
Associated Neurologists, PC
Danbury, Connecticut, 06810, United States
Associated Neurologists of Southern Connecticut, PC
Fairfield, Connecticut, 06824, United States
Aventura Neurological Associates, PA
Aventura, Florida, 33180, United States
Clinical Research South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Wilks & Safirstein MD PA D/B/A MD Clinical
Hallandale, Florida, 33009, United States
Infinity Clinical Research
Hollywood, Florida, 33021, United States
Broward Research
Hollywood, Florida, 33024, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Neurology Associates, P.A.
Maitland, Florida, 32751, United States
LCC Medical Research
Miami, Florida, 33126, United States
Well Pharma Medical Research
Miami, Florida, 33143, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
Clinical Neuroscience Solutions, Inc - Memphis, TN
Orlando, Florida, 32801, United States
Palm Beach Neurological Center / Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, 33410, United States
Qps Mra, Llc
South Miami, Florida, 33143, United States
Meridien Research
Spring Hill, Florida, 34609, United States
University of South Florida
Tampa, Florida, 33612, United States
Meridien Research
Tampa, Florida, 33634, United States
Neurology Research Institute Palm Beach
West Palm Beach, Florida, 33407, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Midtown Neurology
Atlanta, Georgia, 30312, United States
NeuroTrials Research Inc
Atlanta, Georgia, 30342, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Michigan Ave. Internists /Radiant Research, Inc.
Chicago, Illinois, 60604, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Great Lakes Clinical Trials, LLC
Chicago, Illinois, 60640, United States
Robbins Headache Clinic
Riverwoods, Illinois, 60015, United States
Deaconess Clinic Inc.
Evansville, Indiana, 47713, United States
Josephson Wallack Munshower Neurology, P.C.
Indianapolis, Indiana, 46256, United States
Rowe Neurology Institute
Lenexa, Kansas, 66214, United States
College Park Family Care Center Physicians Group- Neurology Research Dept
Overland Park, Kansas, 66210, United States
Kansas Institute of Research
Overland Park, Kansas, 66211, United States
Kentucky Pediatric Research Inc
Bardstown, Kentucky, 40004, United States
Norton Neurology Services
Louisville, Kentucky, 40207, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Pharma Site Research
Baltimore, Maryland, 21208, United States
Seton Medical Group
Baltimore, Maryland, 21228, United States
Boston Clinical Trials Inc
Boston, Massachusetts, 02131, United States
BTC of New Bedford
New Bedford, Massachusetts, 02470, United States
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
Medvadis Research Corporation
Watertown, Massachusetts, 02472, United States
New England Regional Headache Center
Worcester, Massachusetts, 01605, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Women's Health Care Specialists
Kalamazoo, Michigan, 49009, United States
The Minneapolis Clinic of Neurology, Ltd.
Golden Valley, Minnesota, 55422, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
The Headache Center
Ridgeland, Mississippi, 39157, United States
Clinvest
Springfield, Missouri, 65807, United States
Prairie Fields Family Medicine
Fremont, Nebraska, 68025, United States
Clinical Research Advantage, Inc/Synexus USA
Omaha, Nebraska, 68114, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Diagnostic Center of Medicine - Durango / Radiant Research, Inc.
Las Vegas, Nevada, 89117, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
DENT Neurosciences Research Center
Amherst, New York, 14226, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Headache Wellness Center
Greensboro, North Carolina, 27405, United States
Neurology Associates, P.A.
Hickory, North Carolina, 28602, United States
Lake Shore Clinical Research, LLC
Mooresville, North Carolina, 28117, United States
Wake Research Associates LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, 58104, United States
Radiant Research, Inc.
Akron, Ohio, 44311, United States
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Sentral Clinical Research Services
Cincinnati, Ohio, 45212, United States
Patient Priority Clinical Sites
Cincinnati, Ohio, 45215, United States
University of cincinnati
Cincinnati, Ohio, 45219, United States
CTI Clinical research Center
Cincinnati, Ohio, 45227, United States
Radiant Research, Inc
Cincinnati, Ohio, 45249, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Ohio Clinical Research, LLC
Cleveland, Ohio, 44124, United States
Aventiv Research Inc.
Columbus, Ohio, 43213, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
NPC Research
Oklahoma City, Oklahoma, 73109, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Sooner Clinical Research Inc
Oklahoma City, Oklahoma, 73112, United States
Summit Research Network Inc.
Portland, Oregon, 97210, United States
Oregon Center For Clinical Investigations Inc
Portland, Oregon, 97214, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, 19114, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Radiant Research
Anderson, South Carolina, 29621, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
Vista Clinical Research
Columbia, South Carolina, 29201, United States
Hillcrest Clinical Research LLC
Simpsonville, South Carolina, 29681, United States
Clinsearch, LLC
Chattanooga, Tennessee, 37421, United States
Middle Tennessee Clinical Research
Fayetteville, Tennessee, 37334, United States
Holston Medical Group, P.C.
Kingsport, Tennessee, 37660, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
CNS Healthcare
Memphis, Tennessee, 38119, United States
Future Search Trials
Austin, Texas, 78731, United States
Tekton Research
Austin, Texas, 78745, United States
Texas Neurology, P.A.
Dallas, Texas, 75214, United States
Futuresearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Radiant Research, Inc.
Dallas, Texas, 75234, United States
Research Trials Worldwide, LLC
Humble, Texas, 77338, United States
Red Star Research, LLC
Lake Jackson, Texas, 77566, United States
Clinical Trials Texas, Inc
San Antonio, Texas, 78229, United States
Road Runner Research
San Antonio, Texas, 78258, United States
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020, United States
Advanced Research Institute
Ogden, Utah, 84403, United States
Granger Medical Clinic - Riverton
Riverton, Utah, 84065, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, 84102, United States
Highland Clinical Reserach
Salt Lake City, Utah, 84124, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Clinical Research Associates Tidewater
Norfolk, Virginia, 23507, United States
Blue Ridge Research Center
Roanoke, Virginia, 24018, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
The Polyclinic
Seattle, Washington, 98104, United States
South Puget Sound Neurology
Tacoma, Washington, 98409, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (2)
Lipton RB, Dodick DW, Goadsby PJ, Burstein R, Adams AM, Lai J, Yu SY, Finnegan M, Kuang AW, Trugman JM. Efficacy of Ubrogepant in the Acute Treatment of Migraine With Mild Pain vs Moderate or Severe Pain. Neurology. 2022 Oct 25;99(17):e1905-e1915. doi: 10.1212/WNL.0000000000201031. Epub 2022 Aug 17.
PMID: 35977836DERIVEDBlumenfeld AM, Knievel K, Manack Adams A, Severt L, Butler M, Lai H, Dodick DW. Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials. Adv Ther. 2022 Jan;39(1):692-705. doi: 10.1007/s12325-021-01923-3. Epub 2021 Dec 7.
PMID: 34874514DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Adele Thorpe
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 19, 2016
Study Start
September 13, 2016
Primary Completion
August 2, 2018
Study Completion
August 2, 2018
Last Updated
August 28, 2019
Results First Posted
August 28, 2019
Record last verified: 2019-08