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MigrainePhase 3UBRO MMNCT06417775

Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

A Phase 3 study testing Ubrogepant in people with Migraine, run by AbbVie at 106 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Migraine
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
496 participants
Where
106 sitesin 2 countries
Study dates
10 Sep 2024to Nov 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least a 1-year history of migraine with or without aura.
  • Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
  • Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
  • Have regular menstrual cycles of between 21-35 days in length.
  • Less than 15 headache days per month.
  • At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.

Who cannot join

  • History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
  • Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
  • Clinically significant abnormalities in the physical examination as determined by the investigator.
  • Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.
  • Acute headache medication overuse.

Trial locations and contacts

106 sites in 2 countries.

106 sites in 2 countries

United States103 sites

  • Abington Neurological Associates - Abington /ID# 257164

    Abington, Pennsylvania, 19001

  • Albuquerque Clinical Trials, Inc. /ID# 257212

    Albuquerque, New Mexico, 87102

  • Accellacare - McFarland Clinic /ID# 257834

    Ames, Iowa, 50010

  • Dent Neurologic Institute - Amherst /ID# 257219

    Amherst, New York, 14226

  • Michigan Headache & Neurological Institute (MHNI) /ID# 257179

    Ann Arbor, Michigan, 48104-5131

  • NeuroTrials Research /ID# 274507

    Atlanta, Georgia, 30328

  • FutureSearch Trials of Neurology /ID# 257186

    Austin, Texas, 78731

  • Headlands PharmaSite /ID# 257208

    Baltimore, Maryland, 21208

  • Vaught Neurological Services /ID# 267519

    Beckley, West Virginia, 25801

  • Northwest Clinical Research Center /ID# 257381

    Bellevue, Washington, 98007

  • Central Research Associates /ID# 260161

    Birmingham, Alabama, 35205

  • Neurology Offices of South Florida, PLLC /ID# 257161

    Boca Raton, Florida, 33428-2231

  • Boston Clinical Trials /ID# 257132

    Boston, Massachusetts, 02131-2515

  • Hope Clinical Research /ID# 257867

    Canoga Park, California, 91303

  • MD First Research - Chandler /ID# 262564

    Chandler, Arizona, 85286

  • Charlottesville Medical Research /ID# 257154

    Charlottesville, Virginia, 22911

  • WR-ClinSearch /ID# 257160

    Chattanooga, Tennessee, 37421-1605

  • CTI Clinical Research Center /ID# 257162

    Cincinnati, Ohio, 45212-3784

  • C7 Research /ID# 272815

    Cleveland, Ohio, 44109

  • Axiom Research /ID# 257833

    Colton, California, 92324

  • Centricity Research Columbus /ID# 257221

    Columbus, Ohio, 43213

  • Partners In Clinical Research /ID# 257855

    Cumberland, Rhode Island, 02864

  • FutureSearch Trials of Dallas, LP /ID# 257142

    Dallas, Texas, 75231

  • Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403

    DeLand, Florida, 32720

  • Foothill Family Draper Clinic /ID# 277876

    Draper, Utah, 84020

  • Deaconess Midtown Hospital /ID# 257400

    Evansville, Indiana, 47710

  • Wright State Physicians Health Center /ID# 274708

    Fairborn, Ohio, 45324

  • Lillestol Research, LLC /ID# 257896

    Fargo, North Dakota, 58104

  • KCA Neurology /ID# 274495

    Franklin, Tennessee, 37067

  • Methodist Physicians Clinic/CCT Research /ID# 260167

    Fremont, Nebraska, 68025

  • Neuro Pain Research Center /ID# 257155

    Fresno, California, 93710

  • Gilbert Neurology /ID# 260179

    Gilbert, Arizona, 85297

  • Axiom Research, LLC-Los Angeles /ID# 264085

    Glendale, California, 91206

  • Headache Wellness Center /ID# 257136

    Greensboro, North Carolina, 27405

  • Premier Neurology /ID# 260359

    Greenville, South Carolina, 29605

  • IMA Clinical Research Westchester /ID# 259157

    Hartsdale, New York, 10530

  • HealthCare Research Network - Hazelwood /ID# 257402

    Hazelwood, Missouri, 63042

  • Hawaii Pacific Neuroscience /ID# 274469

    Honolulu, Hawaii, 96817

  • Elevate Clinical - Seabrook /ID# 274679

    Houston, Texas, 77058

  • Houston Clinical Research Associates /ID# 272077

    Houston, Texas, 77090

  • Rehabilitation and Neurological Services /ID# 275593

    Huntsville, Alabama, 35805

  • Sun Valley Research Center /ID# 257152

    Imperial, California, 92251-9401

  • Axiom Research - Irvine /ID# 264083

    Irvine, California, 92604

  • Alliance for Multispecialty Research - Knoxville /ID# 257846

    Knoxville, Tennessee, 37920

  • Red Star Research, LLC /ID# 257871

    Lake Jackson, Texas, 77566

  • Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874

    Lakeland, Florida, 33803

  • Radiance Clinical Research /ID# 271727

    Lampasas, Texas, 76550

  • IMA Clinical Research Las Vegas /ID# 258679

    Las Vegas, Nevada, 89102-1955

  • M3 Wake Research-Las Vegas Rainbow /ID# 257895

    Las Vegas, Nevada, 89118-2557

  • Epic Clinical Research - Lewisville /ID# 274480

    Lewisville, Texas, 75057

  • Preferred Research Partners /ID# 262786

    Little Rock, Arkansas, 72211

  • Preferred Research Partners /ID# 273128

    Little Rock, Arkansas, 72211

  • CenExel Collaborative Neuroscience Research /ID# 257828

    Los Alamitos, California, 90720

  • BNL Health - Los Angeles Headache Center /ID# 257237

    Los Angeles, California, 90067-2001

  • Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146

    Marrero, Louisiana, 70072

  • Mind+ Neurology /ID# 274486

    Mequon, Wisconsin, 53092

  • Velocity Clinical Research - Boise /ID# 257135

    Meridian, Idaho, 83642

  • Sms Clinical Research /ID# 278443

    Mesquite, Texas, 75149

  • Well Pharma Medical Research /ID# 257199

    Miami, Florida, 33143

  • Indago Research and Health Center /ID# 277943

    Miami Lakes, Florida, 33016

  • IMA Clinical Research Monroe - Wood /ID# 259362

    Monroe, Louisiana, 71201

  • West Virginia Univ School Med /ID# 258898

    Morgantown, West Virginia, 26506

  • BTC of New Bedford /ID# 257128

    New Bedford, Massachusetts, 02740

  • Fieve Clinical Research, Inc. /ID# 257177

    New York, New York, 10017-1921

  • Rochester Clinical Research /ID# 257193

    New York, New York, 14609

  • M3 Wake Research - Newport Beach /ID# 257158

    Newport Beach, California, 92660

  • Alliance for Multispecialty Research LLC /ID# 257839

    Newton, Kansas, 67114

  • Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851

    Norfolk, Virginia, 23502

  • Coastal Carolina Research Center - North Charleston /ID# 257227

    North Charleston, South Carolina, 29405

  • Sensible Healthcare /ID# 257198

    Ocoee, Florida, 34761

  • Advanced Research Institute /ID# 257853

    Ogden, Utah, 84405

  • Lynn Institute of Oklahoma City /ID# 257857

    Oklahoma City, Oklahoma, 73112

  • Clinical Neuroscience Solutions, Inc /ID# 257190

    Orlando, Florida, 32801-2986

  • Collective Medical Research /ID# 257131

    Overland Park, Kansas, 66210

  • Memorial Healthcare Institute For Neuroscience /ID# 274663

    Owosso, Michigan, 48867

  • Cognitive Clinical Trials (CCT) - Papillion /ID# 260174

    Papillion, Nebraska, 68046-4131

  • Clinical Research of Philadelphia, LLC /ID# 257197

    Philadelphia, Pennsylvania, 19114

  • Foothills Research Center/CCT Research /ID# 260180

    Phoenix, Arizona, 85044

  • True North Neurology /ID# 274672

    Port Jefferson Station, New York, 11776

  • Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139

    Portland, Oregon, 97210

  • Proven Endpoints LLC /ID# 273796

    Ridgeland, Mississippi, 39157

  • J. Lewis Research - Salt Lake City - Foothill Drive /ID# 277877

    Salt Lake City, Utah, 84109

  • J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305

    Salt Lake City, Utah, 84121-6923

  • Highland Clinical Research /ID# 257137

    Salt Lake City, Utah, 84124

  • Artemis Institute for Clinical Research - San Diego /ID# 257134

    San Diego, California, 92103-2204

  • M3 Wake Research - Convoy /ID# 257897

    San Diego, California, 92111

  • Optimus Medical /ID# 257856

    San Francisco, California, 94102

  • Clinvest Research LLC /ID# 257215

    Springfield, Missouri, 65807

  • New England Institute for Clinical Research /ID# 264019

    Stamford, Connecticut, 06905

  • Clinical Research Atlanta - Headlands LLC /ID# 260181

    Stockbridge, Georgia, 30281-9054

  • Puget Sound Neurology /ID# 257174

    Tacoma, Washington, 25328

  • Healthcare Research Network /ID# 257868

    Tinley Park, Illinois, 60477

  • Bio Behavioral Health, Inc /ID# 257140

    Toms River, New Jersey, 08755-6434

  • Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309

    Tucson, Arizona, 85741

  • Central States Research /ID# 277867

    Tulsa, Oklahoma, 74136

  • MedVadis Research /ID# 257156

    Waltham, Massachusetts, 02451

  • IMA Clinical Research Warren /ID# 263641

    Warren Township, New Jersey, 07059

  • Clinpoint Trials /ID# 274524

    Waxahachie, Texas, 75165

  • Alliance For Multispeciality Research - Wichita East /ID# 257148

    Wichita, Kansas, 67207

  • Upstate Clinical Research Associates /ID# 257163

    Williamsville, New York, 14221-6046

  • Accellacare - South Hawthorne Road - Winston-Salem /ID# 257731

    Winston-Salem, North Carolina, 27103

  • Accellacare - South Hawthorne Road - Winston-Salem /ID# 257850

    Winston-Salem, North Carolina, 27103

  • Conquest Research /ID# 258314

    Winter Park, Florida, 32789

Other trials in United States

Puerto Rico3 sites

  • ISIS Clinical Research Center /ID# 262858

    Guaynabo, 00969-2806

  • Instituto De Neurologia Dra. Ivonne Fraga /ID# 262852

    San Juan, 00918

  • BDH Research /ID# 262851

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.

Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 496 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico.

Read more

Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions
Migraine
Being tested
Ubrogepant, Placebo for Ubrogepant
Keywords
Migraine, Menstrual Migraine, Ubrogepant, UBRELVY
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

    Also called UBRELVY

    Oral Tablets

  • Placebo for UbrogepantDrug

    Oral Tablets

Study groups in NCT06417775
Study groupRoleWhat they receive
Double-Blind Period: UbrogepantExperimentalParticipants will receive ubrogepant during the double-blind period.
Receives: Drug: Ubrogepant
Double-Blind Period: Placebo for UbrogepantExperimentalParticipants will receive placebo during the double-blind period.
Receives: Drug: Placebo for Ubrogepant
Open-Label Extension Period: UbrogepantExperimentalEligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.
Receives: Drug: Ubrogepant

What is being measured

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

  1. Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

    Measured: Up to approximately 16 Weeks

  2. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately 68 Weeks

Secondary outcomes (7)

  1. Change From Baseline in Number of Headache Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

    A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.

    Measured: Up to approximately 16 Weeks

  2. Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

    A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.

    Measured: Up to approximately 16 Weeks

  3. Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

    Measured: Up to approximately 16 Weeks

  4. Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days

    Functional Disability Scale (FDS) is a single item used to measure the participant's level of functional disability. Participants will be asked to rate the performance of daily activities in the past 24 hours using 4 response options ranging from "No disability, able to function normally" to "Severely impaired, cannot do all or most things, bed rest may be necessary."

    Measured: Up to approximately 16 Weeks

  5. Change From Baseline in Acute Medication Use Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

    An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.

    Measured: Up to approximately 16 Weeks

  6. Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.

    Measured: Up to approximately 16 Weeks

  7. Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days

    Activity Level is a single-item used to assess overall limitations with performing daily activities over 24 hours with a 5-level response ranging from "Not at all limited" to "Unable to do daily activities."

    Measured: Up to approximately 16 Weeks

Timeline

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

  1. First posted16 May 2024
  2. Study start10 Sep 2024
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
496 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06417775
Sponsor's protocol ID
M23-714
Acronym
UBRO MM
Status last verified
Aug 2026
First submitted
13 May 2024
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ubrogepant in people with Migraine, run by AbbVie at 106 sites in 2 countries.

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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Puerto Rico. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period (time frame: Up to approximately 16 Weeks). 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 NCT06417775.

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 14 Aug 2026.

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