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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

518

Phase

  • 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

    • 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

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
Intervention / Treatment
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
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
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
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
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

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

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

Investigators

  • 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.

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)

August 21, 2020

Primary Completion (Actual)

April 19, 2022

Study Completion (Actual)

April 19, 2022

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

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.

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