Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
NCT ID: NCT02828020
Last Updated: 2019-01-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1672 participants
INTERVENTIONAL
2016-07-22
2017-12-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
NCT02867709
An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
NCT02873221
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
NCT04492020
Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
NCT05264129
Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies
NCT05503082
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ubrogepant 50 mg
1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Ubrogepant
50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Ubrogepant 100 mg
2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Ubrogepant
50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo
2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ubrogepant
50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo-matching Ubrogepant
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Migraine onset before age 50
* History of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
* History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months.
Exclusion Criteria
* Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
* Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
* Has a chronic non-headache pain condition requiring daily pain medication
* Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded
* Has a history of hepatitis within previous 6 months.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adele Thorpe
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Clinical Research Advantage, Inc./Desert Clinical Research, LLC.
Mesa, Arizona, United States
Xenoscience, Inc.
Phoenix, Arizona, United States
Clinical Research Advantage, Inc./Orange Grove Family Practice
Tucson, Arizona, United States
Principals Research Group, Inc.
Hot Springs, Arkansas, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, United States
The Research Center of Southern California, LLC
Carlsbad, California, United States
Med Center
Carmichael, California, United States
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Prime Care Clinical Research
Laguna Hills, California, United States
Collaborative Neuroscience Network, LLC.
Long Beach, California, United States
Synergy San Diego
National City, California, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States
North County Clinical Research
Oceanside, California, United States
Medical Center for Clinical Research
San Diego, California, United States
CA Medical Clinic for Headache
Santa Monica, California, United States
Southern California Research LLC
Simi Valley, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Delta Waves, Inc
Colorado Springs, Colorado, United States
Denver Neurological Research
Denver, Colorado, United States
Associated Neurologists, P.C.
Danbury, Connecticut, United States
Associated Neurolgists of Southern Connecticut, PC
Fairfield, Connecticut, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
CPI MD Clinical
Hallandale, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Palm Beach Neurological Center/Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States
Meridien Research
Spring Hill, Florida, United States
University of South Florida
Tampa, Florida, United States
Meridien Research
Tampa, Florida, United States
Neurology Research Institute
West Palm Beach, Florida, United States
Midtown Neurology
Atlanta, Georgia, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Deaconess Clinic, Medical Office Building 1 Research Institute
Newburgh, Indiana, United States
Rowe Neurology Institute
Lenexa, Kansas, United States
Kansas Institute of Research
Overland Park, Kansas, United States
College Park Family Care Center Physicians Group - Neurology Research Department
Overland Park, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Northeast Medical Research Associates, Inc
South Dartmouth, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, United States
Beyer Research
Kalamazoo, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Clinvest Research, LLC
Springfield, Missouri, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango
Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Central New York Clinical Research
Manlius, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Neurology Associates, P.A.
Hickory, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
PMG Research of Winston-Salem, LLC.
Winston-Salem, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Aventiv Research, Inc
Columbus, Ohio, United States
Ohio Clinical Research, LLC
Lyndhurst, Ohio, United States
MPH IPS Research Company
Oklahoma City, Oklahoma, United States
NPC Research
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Summit Research Network
Portland, Oregon, United States
Oregon Center For Clinical Investigations Inc. (OCCI, Inc.)
Portland, Oregon, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, United States
BTC of Lincoln
Lincoln, Rhode Island, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Tekton Research, Inc.
Austin, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Red Star Research, LLC
Lake Jackson, Texas, United States
Clinical Trials Texas, Inc
San Antonio, Texas, United States
Road Runner Research, Ltd.
San Antonio, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
Granger Medical Clinic-Riverton
Riverton, Utah, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, United States
Highland Clinical Research
Salt Lake City, Utah, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
The Polyclinic Madison Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.
Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.
Lipton RB, Singh RBH, Revicki DA, Zhao S, Shewale AR, Lateiner JE, Dodick DW. Functionality, satisfaction, and global impression of change with ubrogepant for the acute treatment of migraine in triptan insufficient responders: a post hoc analysis of the ACHIEVE I and ACHIEVE II randomized trials. J Headache Pain. 2022 Apr 25;23(1):50. doi: 10.1186/s10194-022-01419-7.
Blumenfeld 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.
Hutchinson S, Silberstein SD, Blumenfeld AM, Lipton RB, Lu K, Yu SY, Severt L. Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II. Cephalalgia. 2021 Aug;41(9):979-990. doi: 10.1177/03331024211000311. Epub 2021 Apr 19.
Hutchinson S, Dodick DW, Treppendahl C, Bennett NL, Yu SY, Guo H, Trugman JM. Ubrogepant for the Acute Treatment of Migraine: Pooled Efficacy, Safety, and Tolerability From the ACHIEVE I and ACHIEVE II Phase 3 Randomized Trials. Neurol Ther. 2021 Jun;10(1):235-249. doi: 10.1007/s40120-021-00234-7. Epub 2021 Feb 20.
Goadsby PJ, Blumenfeld AM, Lipton RB, Dodick DW, Kalidas K, M Adams A, Jakate A, Liu C, Szegedi A, Trugman JM. Time course of efficacy of ubrogepant for the acute treatment of migraine: Clinical implications. Cephalalgia. 2021 Apr;41(5):546-560. doi: 10.1177/0333102420970523. Epub 2020 Nov 26.
Dodick DW, Lipton RB, Ailani J, Lu K, Finnegan M, Trugman JM, Szegedi A. Ubrogepant for the Treatment of Migraine. N Engl J Med. 2019 Dec 5;381(23):2230-2241. doi: 10.1056/NEJMoa1813049.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
More Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UBR-MD-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.