Migraine, With or Without AuraPhase 3ACHIEVE INCT02828020

Efficacy, Safety, and Tolerability Study 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 90 sites in United States.

Completed

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

Official record

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Trial 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. 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: 1,672 participants
Where: 90 sitesUnited States
Study dates: 22 Jul 2016to 14 Dec 2017
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 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, 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.

Trial locations and contacts

90 sites in 1 country.

City, postcode or hospital

90 sites in 1 country

United States90 sites

Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Midtown Neurology
Atlanta, Georgia, 30312
FutureSearch Trials of Neurology
Austin, Texas, 78731
Tekton Research, Inc.
Austin, Texas, 78745
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Northwest Clinical Research Center
Bellevue, Washington, 98007
Boston Clinical Trials
Boston, Massachusetts, 02131
Alpine Clinical Research Center, Inc.
Boulder, Colorado, 80301
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
The Research Center of Southern California, LLC
Carlsbad, California, 92011
Med Center
Carmichael, California, 95608
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
Great Lakes Clinical Trials
Chicago, Illinois, 60640
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Delta Waves, Inc
Colorado Springs, Colorado, 80918
Columbus Regional Research Institute
Columbus, Georgia, 31904
Aventiv Research, Inc
Columbus, Ohio, 43213
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Associated Neurologists, P.C.
Danbury, Connecticut, 06810
Denver Neurological Research
Denver, Colorado, 80210
J. Lewis Research, Inc. / Foothill Family Clinic Draper
Draper, Utah, 84020
T. Joseph Raoof MD, Inc./Encino Research Center
Encino, California, 91436
Regional Clinical Research, Inc.
Endwell, New York, 13760
Associated Neurolgists of Southern Connecticut, PC
Fairfield, Connecticut, 06824
Neurology Center of North Orange County
Fullerton, California, 92835
Sarkis Clinical Trials
Gainesville, Florida, 32607
Behavioral Research Specialists, LLC
Glendale, California, 91206
CPI MD Clinical
Hallandale, Florida, 33009
Neurology Associates, P.A.
Hickory, North Carolina, 28602
Infinity Clinical Research, LLC
Hollywood, Florida, 33024
Principals Research Group, Inc.
Hot Springs, Arkansas, 71901
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Beyer Research
Kalamazoo, Michigan, 49009
Holston Medical Group
Kingsport, Tennessee, 37660
Prime Care Clinical Research
Laguna Hills, California, 92656
Red Star Research, LLC
Lake Jackson, Texas, 77566
Clinical Research Advantage, Inc./Diagnostic Center of Medicine - Durango
Las Vegas, Nevada, 89117
Rowe Neurology Institute
Lenexa, Kansas, 66214
BTC of Lincoln
Lincoln, Rhode Island, 02865
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, 72205
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806
Ohio Clinical Research, LLC
Lyndhurst, Ohio, 44124
Central New York Clinical Research
Manlius, New York, 13104
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Clinical Research Advantage, Inc./Desert Clinical Research, LLC.
Mesa, Arizona, 85213
Clinical Research Institute, Inc.
Minneapolis, Minnesota, 55402
Synergy San Diego
National City, California, 91950
Deaconess Clinic, Medical Office Building 1 Research Institute
Newburgh, Indiana, 47630
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663
North County Clinical Research
Oceanside, California, 92054
MPH IPS Research Company
Oklahoma City, Oklahoma, 73103
NPC Research
Oklahoma City, Oklahoma, 73109
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Kansas Institute of Research
Overland Park, Kansas, 66211
College Park Family Care Center Physicians Group - Neurology Research Department
Overland Park, Kansas, 66212
Palm Beach Neurological Center/Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, 33410
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Xenoscience, Inc.
Phoenix, Arizona, 85004
Summit Research Network
Portland, Oregon, 97210
Oregon Center For Clinical Investigations Inc. (OCCI, Inc.)
Portland, Oregon, 97214
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Granger Medical Clinic-Riverton
Riverton, Utah, 84065
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Optimum Clinical Research, Inc.
Salt Lake City, Utah, 84102
Highland Clinical Research
Salt Lake City, Utah, 84124
Clinical Trials Texas, Inc
San Antonio, Texas, 78229
Road Runner Research, Ltd.
San Antonio, Texas, 78249
Medical Center for Clinical Research
San Diego, California, 92108
CA Medical Clinic for Headache
Santa Monica, California, 90404
The Polyclinic Madison Center
Seattle, Washington, 98104
Southern California Research LLC
Simi Valley, California, 93065
Northeast Medical Research Associates, Inc
South Dartmouth, Massachusetts, 02747
Meridien Research
Spring Hill, Florida, 34609
Encompass Clinical Research
Spring Valley, California, 91978
Clinvest Research, LLC
Springfield, Missouri, 65810
Clinical Research Atlanta
Stockbridge, Georgia, 30281
University of South Florida
Tampa, Florida, 33612
Meridien Research
Tampa, Florida, 33634
Clinical Research Advantage, Inc./Orange Grove Family Practice
Tucson, Arizona, 85741
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23454
MedVadis Research Corporation
Watertown, Massachusetts, 02472
Neurology Research Institute
West Palm Beach, Florida, 33407
PMG Research of Winston-Salem, LLC.
Winston-Salem, North Carolina, 27103

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 (50 and 100 mg) compared to placebo for the acute treatment of a single migraine attack.

Conditions: Migraine, With or Without Aura
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
50 mg 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 NCT02828020
Study group	Role	What they receive
Ubrogepant 50 mg	Experimental	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. Receives: Drug: Ubrogepant; Drug: Placebo-matching Ubrogepant
Ubrogepant 100 mg	Experimental	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. Receives: Drug: Ubrogepant; Drug: Placebo-matching Ubrogepant
Placebo	Placebo comparator	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. Receives: Drug: Placebo-matching Ubrogepant

What is being measured

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

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

Secondary outcomes (6)

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
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 determinable sustained pain relief from 2 to 24 hours after initial dose.
Measured: 2 to 24 hours after initial dose
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 determinable sustained pain freedom from 2 to 24 hours after initial dose.
Measured: 2 to 24 hours after initial dose
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
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
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.

22 Jul 201614 Dec 2017

First posted11 Jul 2016 (estimated)
Study start22 Jul 2016
Primary completion13 Dec 2017
Study completion14 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Migraine, With or Without AuraStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 1,672 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02828020
Sponsor's protocol ID: UBR-MD-01
Acronym: ACHIEVE I
Status last verified: Dec 2018
First submitted: 7 Jul 2016
Last updated: 3 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
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
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.
PubMed 31800988

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02828020
Acronym / sponsor ID: ACHIEVE I / UBR-MD-01
Conditions: Migraine, With or Without Aura
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,672 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 22 Jul 2016 (actual)
Primary completion: 13 Dec 2017 (actual)
Study completion: 14 Dec 2017 (actual)
First posted: 11 Jul 2016 (estimated)
Results: Posted 3 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Ubrogepant 50 mg	Experimental	Drug: Ubrogepant, Drug: Placebo-matching Ubrogepant1 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	Experimental	Drug: Ubrogepant, Drug: Placebo-matching Ubrogepant2 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 comparator	Drug: Placebo-matching Ubrogepant2 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ubrogepant50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.	Drug	Ubrogepant 100 mg, Ubrogepant 50 mg
Placebo-matching UbrogepantPlacebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.	Drug	Placebo, Ubrogepant 100 mg, Ubrogepant 50 mg

Primary outcome

Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose
Time frame: Baseline (Predose) to 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.
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose
Time frame: Baseline (Predose) to 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.

6 secondary outcomes

Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose
Time frame: Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose
Time frame: 2 to 24 hours after initial dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose
Time frame: 2 to 24 hours after initial dose
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose
Time frame: 2 hours after initial dose
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose
Time frame: 2 hours after initial dose
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose
Time frame: 2 hours after initial dose

Results and safety

Results posted to the registry on 3 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	559	479
Ubrogepant 50 mg	556	457
Ubrogepant 100 mg	557	479

Primary outcome: Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose

Time frame: Baseline (Predose) to 2 hours after initial dose. Number. Unit: percentage of participants

Measure	Placebo n = 456	Ubrogepant 50 mg n = 422	Ubrogepant 100 mg n = 448
Value	11.8	19.2	21.2

Placebo vs Ubrogepant 50 mg: Odds Ratio (OR): 1.83 (95% CI 1.25 to 2.66), p = 0.0023, Regression, Logistic
Placebo vs Ubrogepant 100 mg: Odds Ratio (OR): 2.04 (95% CI 1.41 to 2.95), p = 0.0003, Regression, Logistic

Population analysed: Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF).

Primary outcome: Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose

Time frame: Baseline (Predose) to 2 hours after initial dose. Number. Unit: percentage of participants

Measure	Placebo n = 454	Ubrogepant 50 mg n = 420	Ubrogepant 100 mg n = 448
Value	27.8	38.6	37.7

Placebo vs Ubrogepant 50 mg: Odds Ratio (OR): 1.70 (95% CI 1.27 to 2.28), p = 0.0023, Regression, Logistic
Placebo vs Ubrogepant 100 mg: Odds Ratio (OR): 1.63 (95% CI 1.22 to 2.17), p = 0.0023, Regression, Logistic

Population analysed: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose through 30 days after the last dose of study drug (approximately 30 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 485 (0%)	0 of 485 (0%)	0 of 485
Ubrogepant 50 mg	3 of 466 (0.6%)	0 of 466 (0%)	0 of 466
Ubrogepant 100 mg	2 of 485 (0.4%)	0 of 485 (0%)	0 of 485

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39982105Goadsby 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.
Derived from this study: PubMed 36125279Johnston 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.
Derived from this study: PubMed 35468729Lipton 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.
Derived from this study: PubMed 34874514Blumenfeld 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.
Derived from this study: PubMed 33874756Hutchinson 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.
Derived from this study: PubMed 33608814Hutchinson 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.
Derived from this study: PubMed 33241721Goadsby 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.
Derived from this study: PubMed 31800988Dodick 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adele Thorpe study director

Allergan

90 sites in 1 country: see every site and its status.

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 90 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 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 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 3 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 NCT02828020, 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 3 Jan 2019.