Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine
ACHIEVE I
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
1,672
1 country
90
Brief Summary
This study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (50 and 100 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 Jul 2016
90 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
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedStudy Start
First participant enrolled
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2017
CompletedResults Posted
Study results publicly available
January 3, 2019
CompletedJanuary 3, 2019
December 1, 2018
1.4 years
July 7, 2016
December 13, 2018
December 13, 2018
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 severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an 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.
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 50 mg
EXPERIMENTAL1 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 100 mg
EXPERIMENTAL2 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.
Placebo
PLACEBO COMPARATOR2 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.
Interventions
50 mg 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 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, 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (90)
Clinical Research Advantage, Inc./Desert Clinical Research, LLC.
Mesa, Arizona, 85213, United States
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
Clinical Research Advantage, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Principals Research Group, Inc.
Hot Springs, Arkansas, 71901, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
The Research Center of Southern California, LLC
Carlsbad, California, 92011, United States
Med Center
Carmichael, California, 95608, United States
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, 91436, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Prime Care Clinical Research
Laguna Hills, California, 92656, United States
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806, United States
Synergy San Diego
National City, California, 91950, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663, United States
North County Clinical Research
Oceanside, California, 92054, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
CA Medical Clinic for Headache
Santa Monica, California, 90404, United States
Southern California Research LLC
Simi Valley, California, 93065, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, 80301, 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
Associated Neurologists, P.C.
Danbury, Connecticut, 06810, United States
Associated Neurolgists of Southern Connecticut, PC
Fairfield, Connecticut, 06824, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
CPI MD Clinical
Hallandale, Florida, 33009, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33024, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Palm Beach Neurological Center/Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, 33410, 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
West Palm Beach, Florida, 33407, United States
Midtown Neurology
Atlanta, Georgia, 30312, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Deaconess Clinic, Medical Office Building 1 Research Institute
Newburgh, Indiana, 47630, United States
Rowe Neurology Institute
Lenexa, Kansas, 66214, United States
Kansas Institute of Research
Overland Park, Kansas, 66211, United States
College Park Family Care Center Physicians Group - Neurology Research Department
Overland Park, Kansas, 66212, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Northeast Medical Research Associates, Inc
South Dartmouth, Massachusetts, 02747, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, 48104, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Clinvest Research, LLC
Springfield, Missouri, 65810, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango
Las Vegas, Nevada, 89117, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, 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
Neurology Associates, P.A.
Hickory, North Carolina, 28602, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Winston-Salem, LLC.
Winston-Salem, North Carolina, 27103, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Aventiv Research, Inc
Columbus, Ohio, 43213, United States
Ohio Clinical Research, LLC
Lyndhurst, Ohio, 44124, United States
MPH 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
Summit Research Network
Portland, Oregon, 97210, United States
Oregon Center For Clinical Investigations Inc. (OCCI, Inc.)
Portland, Oregon, 97214, United States
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114, United States
BTC of Lincoln
Lincoln, Rhode Island, 02865, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, 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, Ltd.
San Antonio, Texas, 78249, United States
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020, United States
Granger Medical Clinic-Riverton
Riverton, Utah, 84065, United States
Optimum Clinical Research, Inc.
Salt Lake City, Utah, 84102, United States
Highland Clinical Research
Salt Lake City, Utah, 84124, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
The Polyclinic Madison Center
Seattle, Washington, 98104, 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: 33241721DERIVEDDodick 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.
PMID: 31800988DERIVED
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
July 7, 2016
First Posted
July 11, 2016
Study Start
July 22, 2016
Primary Completion
December 13, 2017
Study Completion
December 14, 2017
Last Updated
January 3, 2019
Results First Posted
January 3, 2019
Record last verified: 2018-12