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MigrainePhase 3UBR ProdromeNCT04492020

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

A Phase 3 study testing Ubrogepant 100 mg in people with Migraine, run by AbbVie at 73 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

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
Ubrogepant 100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
518 participants
Where
73 sitesUnited States
Study dates
21 Aug 2020to 19 Apr 2022
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 ICHD-3 (International Classification of Headache Disorders 3rd edition)
  • Migraine onset before age 50 years
  • By history, the participant's migraines typically last 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 in each of the 3 months prior to the Screening Visit

Who cannot join

  • Difficulty distinguishing migraine headache from tension-type or other headaches
  • Participants who overuse medication for migraine defined as use of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
  • Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
  • A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
  • Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1
  • History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded

Trial locations and contacts

73 sites in 1 country.

73 sites in 1 country

United States73 sites

  • Abington Neurological Associates - Abington /ID# 236257

    Abington, Pennsylvania, 19001

  • Lehigh Center for Clinical Research /ID# 236703

    Allentown, Pennsylvania, 18104-5034

  • PMG Research of McFarland /ID# 238271

    Ames, Iowa, 50010-5733

  • Dent Neurosciences Research Center, Inc. /ID# 237039

    Amherst, New York, 14226

  • Michigan Headache & Neurological Institute (MHNI) /ID# 236565

    Ann Arbor, Michigan, 48104-5131

  • NeuroTrials Research Inc. /ID# 237365

    Atlanta, Georgia, 30328

  • FutureSearch Trials of Neurology /ID# 236428

    Austin, Texas, 78731

  • Tekton Research, Inc. /ID# 237306

    Austin, Texas, 78745

  • Northwest Clinical Research Center /ID# 237585

    Bellevue, Washington, 98007

  • Achieve Clinical Research, LLC /ID# 237098

    Birmingham, Alabama, 35216

  • Northwest Clinical Trials /ID# 234968

    Boise, Idaho, 83704

  • Boston Clinical Trials /ID# 236559

    Boston, Massachusetts, 02131-2515

  • DiscoveResearch, Inc /ID# 236273

    Bryan, Texas, 77802

  • Clinical Trials of SC /ID# 237338

    Charleston, South Carolina, 29406

  • PMG Research of Charlotte /ID# 237048

    Charlotte, North Carolina, 28209

  • Charlottesville Medical Research /ID# 237792

    Charlottesville, Virginia, 22911

  • WR-ClinSearch /ID# 238287

    Chattanooga, Tennessee, 37421-1605

  • CTI Clinical Research Center /ID# 237278

    Cincinnati, Ohio, 45212

  • University of Cincinnati /ID# 234403

    Cincinnati, Ohio, 45267

  • StudyMetrix Research /ID# 236457

    City of Saint Peters, Missouri, 63303

  • Colorado Springs Neurological Associates (CSNA) /ID# 236556

    Colorado Springs, Colorado, 80907

  • Aventiv Research Columbus /ID# 236837

    Columbus, Ohio, 43213

  • FutureSearch Trials of Dallas, LP /ID# 236276

    Dallas, Texas, 75231

  • iResearch Atlanta, LLC /ID# 237390

    Decatur, Georgia, 30030

  • OK Clinical Research /ID# 236675

    Edmond, Oklahoma, 73034-3257

  • Deaconess Clinic Downtown /ID# 236959

    Evansville, Indiana, 47713-1227

  • Advanced Neurosciences Research, LLC /ID# 237426

    Fort Collins, Colorado, 80528

  • California Headache and Balance Center /ID# 236247

    Fresno, California, 93720

  • Minneapolis Clinic of Neurology - Golden Valley /ID# 238162

    Golden Valley, Minnesota, 55422-4215

  • Centex Studies, Inc. - Houston /ID# 237458

    Houston, Texas, 77058

  • Sun Valley Research Center /ID# 236561

    Imperial, California, 92251-9401

  • CNS Healthcare - Jacksonville /ID# 238245

    Jacksonville, Florida, 32256-6039

  • Health Awareness, Inc - Jupiter /ID# 236226

    Jupiter, Florida, 33458-7021

  • Arkansas Clinical Research /ID# 238032

    Little Rock, Arkansas, 72205

  • Wr-Pri Llc /Id# 236007

    Los Alamitos, California, 90720

  • Central New York Clinical Research /ID# 235694

    Manlius, New York, 13104

  • Suburban Research Associates - Media /ID# 236698

    Media, Pennsylvania, 19063-1760

  • CNS Healthcare - Memphis /ID# 236396

    Memphis, Tennessee, 38119

  • Clinical Research Institute, Inc /ID# 238301

    Minneapolis, Minnesota, 55402-2606

  • Suncoast Clinical Research /ID# 236934

    New Port Richey, Florida, 34652

  • Rochester Clinical Research /ID# 236842

    New York, New York, 14609

  • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691

    Newport Beach, California, 92660

  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253

    Newport News, Virginia, 23606

  • Excell Research, Inc /ID# 237721

    Oceanside, California, 92056

  • Sensible Healthcare /ID# 238090

    Ocoee, Florida, 34761

  • Advanced Research Institute /ID# 237749

    Ogden, Utah, 84403

  • IPS Research Company /ID# 237674

    Oklahoma City, Oklahoma, 73106

  • Clinical Neuroscience Solutions, Inc /ID# 236608

    Orlando, Florida, 32801-2986

  • Collective Medical Research /ID# 236402

    Overland Park, Kansas, 66210

  • Kansas Institute of Research /ID# 236738

    Overland Park, Kansas, 66211-1363

  • Thomas Jefferson University Jefferson Headache Center /ID# 235821

    Philadelphia, Pennsylvania, 19107

  • Barrow Neuro Institute /ID# 236775

    Phoenix, Arizona, 85013

  • Summit Headlands LLC /ID# 236077

    Portland, Oregon, 97210

  • Raleigh Neurology Associates /ID# 237138

    Raleigh, North Carolina, 27607

  • University of Utah /ID# 237602

    Salt Lake City, Utah, 84112-5500

  • Meridian Clinical Research (Neurology) - Savannah /ID# 234371

    Savannah, Georgia, 31406-2758

  • Seattle Clinical Research Center /ID# 236912

    Seattle, Washington, 98105

  • Princeton Center for Clinical Research /ID# 235734

    Skillman, New Jersey, 08558

  • Frontier Clinical Research /ID# 237924

    Smithfield, Pennsylvania, 15478

  • Clinvest Research LLC /ID# 237908

    Springfield, Missouri, 65807

  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163

    St. Petersburg, Florida, 33709-3113

  • Clinical Research Atlanta - Headlands LLC /ID# 234438

    Stockbridge, Georgia, 30281-9054

  • Puget Sound Neurology /ID# 236322

    Tacoma, Washington, 25328

  • University of South Florida /ID# 234387

    Tampa, Florida, 33606

  • ForCare Clinical Research /ID# 237092

    Tampa, Florida, 33613-1244

  • Bio Behavioral Health, Inc /ID# 238212

    Toms River, New Jersey, 08755-6434

  • George J. Rederich M.D. Inc. /ID# 235769

    Torrance, California, 90505

  • Tidewater Integr Med Research /ID# 236867

    Virginia Beach, Virginia, 23451

  • Sentara Neurology Specialists - Virginia Beach /ID# 234350

    Virginia Beach, Virginia, 23456-0019

  • Diablo Clinical Research /ID# 237570

    Walnut Creek, California, 94598

  • ClinPoint Trials /ID# 236618

    Waxahachie, Texas, 75165-1430

  • Premiere Research Institute - Palm Beach /ID# 238193

    West Palm Beach, Florida, 33407-3209

  • Upstate Clinical Research Associates /ID# 238220

    Williamsville, New York, 14221-6046

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

Conditions
Migraine
Being tested
Ubrogepant 100 mg, Placebo
Keywords
Migraine
Medical subject headings
Migraine Disorders

What participants receive

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

  • Ubrogepant 100 mgDrug

    For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours

  • PlaceboDrug

    For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours

Study groups in NCT04492020
Study groupRoleWhat they receive
Treatment Sequence AExperimentalParticipants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
Receives: Drug: Ubrogepant 100 mg; Drug: Placebo
Treatment Sequence BExperimentalParticipants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event
Receives: Drug: Ubrogepant 100 mg; Drug: Placebo

What is being measured

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

  1. Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose

    The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.

    Measured: 24 hours after taking double-blind study intervention during the prodrome

Secondary outcomes (3)

  1. Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose

    The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache

    Measured: 48 hours after taking double-blind study intervention during the prodrome

  2. Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose

    The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome

    Measured: 24 hours after taking double-blind study intervention during the prodrome

  3. Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose

    The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.

    Measured: 24 hours after taking double-blind study intervention during the prodrome

Timeline

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

  1. First posted30 Jul 2020
  2. Study start21 Aug 2020
  3. Primary completion19 Apr 2022
  4. Study completion19 Apr 2022

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04492020
Sponsor's protocol ID
3110-304-002
Acronym
UBR Prodrome
Status last verified
May 2023
First submitted
27 Jul 2020
Last updated
31 May 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

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

  • Schwedt TJ, Lipton RB, Goadsby PJ, Chiang CC, Klein BC, Hussar C, Liu C, Yu SY, Finnegan M, Trugman JM. Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period. Neurol Clin Pract. 2025 Feb;15(1):e200359. doi: 10.1212/CPJ.0000000000200359. Epub 2024 Oct 8.

    PubMed 39399572

  • Lipton RB, Harriott AM, Ma JY, Smith JH, Stokes J, Gandhi P, Jariwala-Parikh K, Jensen GS, Trugman JM, Dodick DW. Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial. Neurology. 2024 Sep 24;103(6):e209745. doi: 10.1212/WNL.0000000000209745. Epub 2024 Aug 28.

    PubMed 39197113

  • Dodick DW, Goadsby PJ, Schwedt TJ, Lipton RB, Liu C, Lu K, Yu SY, Severt L, Finnegan M, Trugman JM. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 Dec 16;402(10419):2307-2316. doi: 10.1016/S0140-6736(23)01683-5. Epub 2023 Nov 15.

    PubMed 37979595

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ubrogepant 100 mg in people with Migraine, run by AbbVie at 73 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 8 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 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. 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 31 May 2023). 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 Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose (time frame: 24 hours after taking double-blind study intervention during the prodrome). 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 NCT04492020, which also lists 4 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 31 May 2023.

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