Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
ACHIEVE II
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Single Attack Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine
1 other identifier
interventional
1,686
1 country
109
Brief Summary
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2016
109 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 12, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedStudy Start
First participant enrolled
August 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2018
CompletedResults Posted
Study results publicly available
January 29, 2019
CompletedMarch 19, 2019
March 1, 2019
1.4 years
August 12, 2016
January 9, 2019
March 1, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.
Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.
Baseline (Predose) to 2 hours after initial dose
Secondary Outcomes (6)
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
2 to 24 hours after initial dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
2 to 24 hours after initial dose
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
2 hours after initial dose
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
2 hours after initial dose
- +1 more secondary outcomes
Study Arms (3)
Ubrogepant 25 mg
EXPERIMENTAL1 ubrogepant 25 milligram (mg) tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Ubrogepant 50 mg
EXPERIMENTAL1 ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Placebo
PLACEBO COMPARATOR1 placebo-matching ubrogepant tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take placebo-matching ubrogepant tablet or rescue medication, orally, 2 to 48 hours after initial dose.
Interventions
Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
Eligibility Criteria
You may qualify if:
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition, beta version
- 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.
You may not qualify if:
- Difficulty distinguishing migraine headache from tension-type other headaches
- 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, diarrhoea 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (109)
Clinical Research Advantage, Inc./Simon Williamson Clinic
Birmingham, Alabama, 35211, United States
Clinical Research Advantage, Inc./East Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)
Phoenix, Arizona, 85013, United States
Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, 85020, United States
Mayo Clinic Arizona, May Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Radiant Research Inc.
Tucson, Arizona, 85712, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Axiom Research, LLC
Apple Valley, California, 92307, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Axiom Research, LLC
Colton, California, 92324, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
California Headache and Balance Center
Fresno, California, 93720, United States
Sun Valley Research Center
Imperial, California, 92251, United States
Grossmont Center For Clinical Research
La Mesa, California, 91942, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
California Advanced Neurotherapeutic, Inc.
Los Angeles, California, 90024, United States
Cedars Sinai Pain Center
Los Angeles, California, 90048, United States
Pharmacology Research Institute
Newport Beach, California, 92660, 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
Clinical Research Advantage, Inc./Cassidy Medical Group-Vista
Vista, California, 92083, United States
Clinicos, LLC
Colorado Springs, Colorado, 80904, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Radiant Clinical Research
Washington D.C., District of Columbia, 20016, United States
Aventura Neurological Associates
Aventura, Florida, 33180, United States
Clinical Research South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Broward Research Group
Hollywood, Florida, 33024, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Neurology Associates, P.A.
Maitland, Florida, 32751, United States
LCC Medical Research Institute, LLC
Miami, Florida, 33126, United States
Well Pharma Medical Research, Corp.
Miami, Florida, 33143, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Sensible Healthcare, LLC
Ocoee, Florida, 34761, United States
QPS MRA, LLC (Miami Research Associates)
South Miami, Florida, 33143, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
The Kaufmann Clinic, Inc.
Atlanta, Georgia, 30308, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Clinical Research Advantage, Inc./Michigan Avenue Internists
Chicago, Illinois, 60604, United States
Cedar Crosse Research Center
Chicago, Illinois, 60607, United States
Robbins Headache Clinic
Riverwoods, Illinois, 60015, United States
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, 46256, United States
Norton Neurology Services MS Services
Louisville, Kentucky, 40207, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Seton Medical Group
Baltimore, Maryland, 21228, United States
Overlea Personal Physicians
Baltimore, Maryland, 21236, United States
BTC of New Bedford
New Bedford, Massachusetts, 02740, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
New England Regional Headache Center, Inc.
Worcester, Massachusetts, 01605, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422, United States
The Headache Center
Ridgeland, Mississippi, 39157, United States
Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC
Fremont, Nebraska, 68025, United States
Clinical Research Advantage, Inc
Omaha, Nebraska, 68114, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Hope Research Institute
Las Vegas, Nevada, 89106, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, 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
DENT Neurosciences Research Center
Amherst, New York, 14226, United States
Cushing Neuroscience Institute North Shore-LIJ Medical Group
Great Neck, New York, 11021, United States
ProHealth Care Associates, LLP
Plainview, New York, 11803, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221, United States
Westchester Neuro. Const
Yonkers, New York, 10701, United States
Carolina Headache Institute
Durham, North Carolina, 27713, United States
Headache Wellness Center, PC
Greensboro, North Carolina, 27405, United States
Lake Shore Clinical Research, LLC
Mooresville, North Carolina, 28117, United States
Raleigh Neurology Associates, PA
Raleigh, North Carolina, 27607, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, 58104, United States
Radiant Research, Inc.
Akron, Ohio, 44311, United States
Sentral Clinical Research Services
Cincinnati, Ohio, 45212, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45215, United States
University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohio, 45219, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45227, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, 15236, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Abington Neurological Associates, Ltd.
Willow Grove, Pennsylvania, 19090, United States
Radiant Research, Inc.
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
Middle Tennessee Clinical Research
Fayetteville, Tennessee, 37334, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)
Memphis, Tennessee, 38120, United States
Texas Neurology, P.A.
Dallas, Texas, 75214, United States
Radiant Research, Inc
Dallas, Texas, 75234, United States
Research Trials Worldwide, LLC
Humble, Texas, 77338, United States
Advanced Research Institute
Ogden, Utah, 84403, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
iNeuro Headache Specialist
McLean, Virginia, 22102, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Blue Ridge Research Center, LLC
Roanoke, Virginia, 24018, United States
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456, United States
Summit Research Network Seattle, LLC
Seattle, Washington, 98104, United States
South Puget Sound Neurology
Tacoma, Washington, 98409, United States
West Virginia University, Department of Neurology
Morgantown, West Virginia, 26506, United States
Medical College of Wisconsin, Department of Neurology
Milwaukee, Wisconsin, 53226, United States
Related Publications (8)
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.
PMID: 39982105DERIVEDJohnston 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.
PMID: 36125279DERIVEDLipton 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.
PMID: 35468729DERIVEDBlumenfeld 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: 34874514DERIVEDHutchinson 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.
PMID: 33874756DERIVEDHutchinson 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.
PMID: 33608814DERIVEDGoadsby 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.
PMID: 33241721DERIVEDLipton RB, Dodick DW, Ailani J, Lu K, Finnegan M, Szegedi A, Trugman JM. Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1887-1898. doi: 10.1001/jama.2019.16711.
PMID: 31742631DERIVED
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2016
First Posted
August 16, 2016
Study Start
August 26, 2016
Primary Completion
January 25, 2018
Study Completion
February 26, 2018
Last Updated
March 19, 2019
Results First Posted
January 29, 2019
Record last verified: 2019-03