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Migraine, With or Without AuraPhase 3ACHIEVE IINCT02867709

Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

A Phase 3 study testing Ubrogepant in people with Migraine, With or Without Aura, run by Allergan at 109 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine, With or Without Aura
What is being tested?
Ubrogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,686 participants
Where
109 sitesUnited States
Study dates
26 Aug 2016to 26 Feb 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

109 sites in 1 country.

109 sites in 1 country

United States109 sites

  • Radiant Research, Inc.

    Akron, Ohio, 44311

  • DENT Neurosciences Research Center

    Amherst, New York, 14226

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Radiant Research, Inc.

    Anderson, South Carolina, 29621

  • Axiom Research, LLC

    Apple Valley, California, 92307

  • The Kaufmann Clinic, Inc.

    Atlanta, Georgia, 30308

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30342

  • Aventura Neurological Associates

    Aventura, Florida, 33180

  • Seton Medical Group

    Baltimore, Maryland, 21228

  • Overlea Personal Physicians

    Baltimore, Maryland, 21236

  • Clinical Research Advantage, Inc./Simon Williamson Clinic

    Birmingham, Alabama, 35211

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Clinical Research Advantage, Inc./East Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • Clinical Research Advantage, Inc./Michigan Avenue Internists

    Chicago, Illinois, 60604

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • Sentral Clinical Research Services

    Cincinnati, Ohio, 45212

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio, 45215

  • University of Cincinnati Dept of Psychiatry & Behavioral Neuroscience

    Cincinnati, Ohio, 45219

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45227

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Clinicos, LLC

    Colorado Springs, Colorado, 80904

  • Axiom Research, LLC

    Colton, California, 92324

  • Vista Clinical Research

    Columbia, South Carolina, 29201

  • Clinical Research South Florida

    Coral Gables, Florida, 33134

  • Texas Neurology, P.A.

    Dallas, Texas, 75214

  • Radiant Research, Inc

    Dallas, Texas, 75234

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Carolina Headache Institute

    Durham, North Carolina, 27713

  • Pharmacology Research Institute

    Encino, California, 91316

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Plains Clinical Research Center, LLC

    Fargo, North Dakota, 58104

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Middle Tennessee Clinical Research

    Fayetteville, Tennessee, 37334

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado, 80528

  • Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC

    Fremont, Nebraska, 68025

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • California Headache and Balance Center

    Fresno, California, 93720

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Cushing Neuroscience Institute North Shore-LIJ Medical Group

    Great Neck, New York, 11021

  • Headache Wellness Center, PC

    Greensboro, North Carolina, 27405

  • Broward Research Group

    Hollywood, Florida, 33024

  • Research Trials Worldwide, LLC

    Humble, Texas, 77338

  • Sun Valley Research Center

    Imperial, California, 92251

  • Josephson Wallack Munshower Neurology P.C.

    Indianapolis, Indiana, 46256

  • Health Awareness, Inc.

    Jupiter, Florida, 33458

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Grossmont Center For Clinical Research

    La Mesa, California, 91942

  • Hope Research Institute

    Las Vegas, Nevada, 89106

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • California Advanced Neurotherapeutic, Inc.

    Los Angeles, California, 90024

  • Cedars Sinai Pain Center

    Los Angeles, California, 90048

  • Norton Neurology Services MS Services

    Louisville, Kentucky, 40207

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Neurology Associates, P.A.

    Maitland, Florida, 32751

  • iNeuro Headache Specialist

    McLean, Virginia, 22102

  • Baptist Memorial Medical Group (Neurology Specialist - Headache Clinic)

    Memphis, Tennessee, 38120

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • LCC Medical Research Institute, LLC

    Miami, Florida, 33126

  • Well Pharma Medical Research, Corp.

    Miami, Florida, 33143

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Medical College of Wisconsin, Department of Neurology

    Milwaukee, Wisconsin, 53226

  • Lake Shore Clinical Research, LLC

    Mooresville, North Carolina, 28117

  • West Virginia University, Department of Neurology

    Morgantown, West Virginia, 26506

  • BTC of New Bedford

    New Bedford, Massachusetts, 02740

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • Advanced Research Institute

    Ogden, Utah, 84403

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Clinical Research Advantage, Inc

    Omaha, Nebraska, 68114

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • St. Joseph's Hospital & Medical Center - Barrow Neurologic Institute (BNI)

    Phoenix, Arizona, 85013

  • Clinical Research Advantage, Inc./Central Phoenix Medical Clinic, LLC

    Phoenix, Arizona, 85020

  • Preferred Primary Care Physicians, Inc.

    Pittsburgh, Pennsylvania, 15236

  • ProHealth Care Associates, LLP

    Plainview, New York, 11803

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • Raleigh Neurology Associates, PA

    Raleigh, North Carolina, 27607

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730

  • Desert Valley Research

    Rancho Mirage, California, 92270

  • George J Rederich MD, Inc

    Redondo Beach, California, 90277

  • The Headache Center

    Ridgeland, Mississippi, 39157

  • Robbins Headache Clinic

    Riverwoods, Illinois, 60015

  • Blue Ridge Research Center, LLC

    Roanoke, Virginia, 24018

  • Artemis Institute For Clinical Research

    San Diego, California, 92103

  • Mayo Clinic Arizona, May Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Summit Research Network Seattle, LLC

    Seattle, Washington, 98104

  • Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina, 29681

  • Princeton Center for Clinical Research

    Skillman, New Jersey, 08558

  • QPS MRA, LLC (Miami Research Associates)

    South Miami, Florida, 33143

  • South Puget Sound Neurology

    Tacoma, Washington, 98409

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Radiant Research Inc.

    Tucson, Arizona, 85712

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456

  • Clinical Research Advantage, Inc./Cassidy Medical Group-Vista

    Vista, California, 92083

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Radiant Clinical Research

    Washington D.C., District of Columbia, 20016

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York, 14221

  • Abington Neurological Associates, Ltd.

    Willow Grove, Pennsylvania, 19090

  • New England Regional Headache Center, Inc.

    Worcester, Massachusetts, 01605

  • Westchester Neuro. Const

    Yonkers, New York, 10701

Other trials in United States

About this study

Official title: 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

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.

Being tested
Ubrogepant, Placebo-matching Ubrogepant
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UbrogepantDrug

    Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

  • Placebo-matching UbrogepantDrug

    Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.

Study groups in NCT02867709
Study groupRoleWhat they receive
Ubrogepant 25 mgExperimental1 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.
Receives: Drug: Ubrogepant; Drug: Placebo-matching Ubrogepant
Ubrogepant 50 mgExperimental1 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.
Receives: Drug: Ubrogepant; Drug: Placebo-matching Ubrogepant
PlaceboPlacebo 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.
Receives: Drug: Placebo-matching Ubrogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Predose) to 2 hours after initial dose

  2. 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.

    Measured: Baseline (Predose) to 2 hours after initial dose

Secondary outcomes (6)

  1. Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose

    Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.

    Measured: Baseline (Predose) to 2 hours after initial dose

  2. Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose

    Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.

    Measured: 2 to 24 hours after initial dose

  3. Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose

    Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.

    Measured: 2 to 24 hours after initial dose

  4. Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose

    Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.

    Measured: 2 hours after initial dose

  5. Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose

    Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.

    Measured: 2 hours after initial dose

  6. Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose

    Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.

    Measured: 2 hours after initial dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2016 (estimated)
  2. Study start26 Aug 2016
  3. Primary completion25 Jan 2018
  4. Study completion26 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,686 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867709
Sponsor's protocol ID
UBR-MD-02
Acronym
ACHIEVE II
Status last verified
Mar 2019
First submitted
12 Aug 2016
Last updated
19 Mar 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39982105

  • 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.

    PubMed 36125279

  • 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.

    PubMed 35468729

  • 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.

    PubMed 34874514

  • 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.

    PubMed 33874756

  • 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.

    PubMed 33608814

  • 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.

    PubMed 33241721

  • Lipton 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.

    PubMed 31742631

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ubrogepant in people with Migraine, With or Without Aura, run by Allergan at 109 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose (time frame: Baseline (Predose) to 2 hours after initial dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867709, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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