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

May 30, 2023 updated by: AbbVie

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
518

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research, LLC /ID# 237098
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neuro Institute /ID# 236775
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Clinical Research /ID# 238032
    • California
      • Fresno, California, United States, 93720
        • California Headache and Balance Center /ID# 236247
      • Imperial, California, United States, 92251-9401
        • Sun Valley Research Center /ID# 236561
      • Los Alamitos, California, United States, 90720
        • Wr-Pri Llc /Id# 236007
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691
      • Oceanside, California, United States, 92056
        • Excell Research, Inc /ID# 237721
      • Torrance, California, United States, 90505
        • George J. Rederich M.D. Inc. /ID# 235769
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research /ID# 237570
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Neurological Associates (CSNA) /ID# 236556
      • Fort Collins, Colorado, United States, 80528
        • Advanced Neurosciences Research, LLC /ID# 237426
    • Florida
      • Jacksonville, Florida, United States, 32256-6039
        • CNS Healthcare - Jacksonville /ID# 238245
      • Jupiter, Florida, United States, 33458-7021
        • Health Awareness, Inc - Jupiter /ID# 236226
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research /ID# 236934
      • Ocoee, Florida, United States, 34761
        • Sensible Healthcare /ID# 238090
      • Orlando, Florida, United States, 32801-2986
        • Clinical Neuroscience Solutions, Inc /ID# 236608
      • Saint Petersburg, Florida, United States, 33709-3113
        • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163
      • Tampa, Florida, United States, 33606
        • University of South Florida /ID# 234387
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research /ID# 237092
      • West Palm Beach, Florida, United States, 33407-3209
        • Premiere Research Institute - Palm Beach /ID# 238193
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • NeuroTrials Research Inc. /ID# 237365
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC /ID# 237390
      • Savannah, Georgia, United States, 31406-2758
        • Meridian Clinical Research (Neurology) - Savannah /ID# 234371
      • Stockbridge, Georgia, United States, 30281-9054
        • Clinical Research Atlanta - Headlands LLC /ID# 234438
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials /ID# 234968
    • Indiana
      • Evansville, Indiana, United States, 47713-1227
        • Deaconess Clinic Downtown /ID# 236959
    • Iowa
      • Ames, Iowa, United States, 50010-5733
        • PMG Research of McFarland /ID# 238271
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Collective Medical Research /ID# 236402
      • Overland Park, Kansas, United States, 66211-1363
        • Kansas Institute of Research /ID# 236738
    • Massachusetts
      • Boston, Massachusetts, United States, 02131-2515
        • Boston Clinical Trials /ID# 236559
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Michigan Headache & Neurological Institute (MHNI) /ID# 236565
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422-4215
        • Minneapolis Clinic of Neurology - Golden Valley /ID# 238162
      • Minneapolis, Minnesota, United States, 55402-2606
        • Clinical Research Institute, Inc /ID# 238301
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research /ID# 236457
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC /ID# 237908
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Princeton Center for Clinical Research /ID# 235734
      • Toms River, New Jersey, United States, 08755-6434
        • Bio Behavioral Health, Inc /ID# 238212
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center, Inc. /ID# 237039
      • Manlius, New York, United States, 13104
        • Central New York Clinical Research /ID# 235694
      • New York, New York, United States, 14609
        • Rochester Clinical Research /ID# 236842
      • Williamsville, New York, United States, 14221-6046
        • Upstate Clinical Research Associates /ID# 238220
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte /ID# 237048
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates /ID# 237138
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center /ID# 237278
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati /ID# 234403
      • Columbus, Ohio, United States, 43213
        • Aventiv Research Columbus /ID# 236837
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034-3257
        • OK Clinical Research /ID# 236675
      • Oklahoma City, Oklahoma, United States, 73106
        • IPS Research Company /ID# 237674
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Headlands LLC /ID# 236077
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Neurological Associates - Abington /ID# 236257
      • Allentown, Pennsylvania, United States, 18104-5034
        • Lehigh Center for Clinical Research /ID# 236703
      • Media, Pennsylvania, United States, 19063-1760
        • Suburban Research Associates - Media /ID# 236698
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Jefferson Headache Center /ID# 235821
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research /ID# 237924
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of SC /ID# 237338
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421-1605
        • WR-ClinSearch /ID# 238287
      • Memphis, Tennessee, United States, 38119
        • CNS Healthcare - Memphis /ID# 236396
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology /ID# 236428
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc. /ID# 237306
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc /ID# 236273
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP /ID# 236276
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc. - Houston /ID# 237458
      • Waxahachie, Texas, United States, 75165-1430
        • ClinPoint Trials /ID# 236618
    • Utah
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 237749
      • Salt Lake City, Utah, United States, 84112-5500
        • University of Utah /ID# 237602
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research /ID# 237792
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253
      • Virginia Beach, Virginia, United States, 23451
        • Tidewater Integr Med Research /ID# 236867
      • Virginia Beach, Virginia, United States, 23456-0019
        • Sentara Neurology Specialists - Virginia Beach /ID# 234350
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center /ID# 237585
      • Seattle, Washington, United States, 98105
        • Seattle Clinical Research Center /ID# 236912
      • Tacoma, Washington, United States, 25328
        • Puget Sound Neurology /ID# 236322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Sequence A
Participants 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
Drug: Placebo
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
Drug: Ubrogepant 100 mg
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
Experimental: Treatment Sequence B
Participants 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
Drug: Placebo
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
Drug: Ubrogepant 100 mg
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
24 hours after taking double-blind study intervention during the prodrome

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
Time Frame: 48 hours after taking double-blind study intervention during the prodrome
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
48 hours after taking double-blind study intervention during the prodrome
Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
Time Frame: 24 hours after taking double-blind study intervention during the prodrome
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
24 hours after taking double-blind study intervention during the prodrome
Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
Time Frame: 24 hours after taking double-blind study intervention during the prodrome
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.
24 hours after taking double-blind study intervention during the prodrome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3110-304-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings