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

NCT04492020 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 3110-304-002
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 73

Brief Summary

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

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

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

  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

  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

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

Study Arms (2)

Treatment Sequence A

EXPERIMENTAL

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: Ubrogepant 100 mg; Drug: Placebo

Treatment Sequence B

EXPERIMENTAL

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: Ubrogepant 100 mg; Drug: Placebo

Interventions

Ubrogepant 100 mg DRUG

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

Treatment Sequence A; Treatment Sequence B

Placebo DRUG

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

Treatment Sequence A; Treatment Sequence B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (73)

Achieve Clinical Research, LLC /ID# 237098

Birmingham, Alabama, 35216, United States

Location

Barrow Neuro Institute /ID# 236775

Phoenix, Arizona, 85013, United States

Location

Arkansas Clinical Research /ID# 238032

Little Rock, Arkansas, 72205, United States

Location

California Headache and Balance Center /ID# 236247

Fresno, California, 93720, United States

Location

Sun Valley Research Center /ID# 236561

Imperial, California, 92251-9401, United States

Location

Wr-Pri Llc /Id# 236007

Los Alamitos, California, 90720, United States

Location

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

Newport Beach, California, 92660, United States

Location

Excell Research, Inc /ID# 237721

Oceanside, California, 92056, United States

Location

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

Torrance, California, 90505, United States

Location

Diablo Clinical Research /ID# 237570

Walnut Creek, California, 94598, United States

Location

Colorado Springs Neurological Associates (CSNA) /ID# 236556

Colorado Springs, Colorado, 80907, United States

Location

Advanced Neurosciences Research, LLC /ID# 237426

Fort Collins, Colorado, 80528, United States

Location

CNS Healthcare - Jacksonville /ID# 238245

Jacksonville, Florida, 32256-6039, United States

Location

Health Awareness, Inc - Jupiter /ID# 236226

Jupiter, Florida, 33458-7021, United States

Location

Suncoast Clinical Research /ID# 236934

New Port Richey, Florida, 34652, United States

Location

Sensible Healthcare /ID# 238090

Ocoee, Florida, 34761, United States

Location

Clinical Neuroscience Solutions, Inc /ID# 236608

Orlando, Florida, 32801-2986, United States

Location

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

St. Petersburg, Florida, 33709-3113, United States

Location

University of South Florida /ID# 234387

Tampa, Florida, 33606, United States

Location

ForCare Clinical Research /ID# 237092

Tampa, Florida, 33613-1244, United States

Location

Premiere Research Institute - Palm Beach /ID# 238193

West Palm Beach, Florida, 33407-3209, United States

Location

NeuroTrials Research Inc. /ID# 237365

Atlanta, Georgia, 30328, United States

Location

iResearch Atlanta, LLC /ID# 237390

Decatur, Georgia, 30030, United States

Location

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

Savannah, Georgia, 31406-2758, United States

Location

Clinical Research Atlanta - Headlands LLC /ID# 234438

Stockbridge, Georgia, 30281-9054, United States

Location

Northwest Clinical Trials /ID# 234968

Boise, Idaho, 83704, United States

Location

Deaconess Clinic Downtown /ID# 236959

Evansville, Indiana, 47713-1227, United States

Location

PMG Research of McFarland /ID# 238271

Ames, Iowa, 50010-5733, United States

Location

Collective Medical Research /ID# 236402

Overland Park, Kansas, 66210, United States

Location

Kansas Institute of Research /ID# 236738

Overland Park, Kansas, 66211-1363, United States

Location

Boston Clinical Trials /ID# 236559

Boston, Massachusetts, 02131-2515, United States

Location

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

Ann Arbor, Michigan, 48104-5131, United States

Location

Minneapolis Clinic of Neurology - Golden Valley /ID# 238162

Golden Valley, Minnesota, 55422-4215, United States

Location

Clinical Research Institute, Inc /ID# 238301

Minneapolis, Minnesota, 55402-2606, United States

Location

StudyMetrix Research /ID# 236457

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research LLC /ID# 237908

Springfield, Missouri, 65807, United States

Location

Princeton Center for Clinical Research /ID# 235734

Skillman, New Jersey, 08558, United States

Location

Bio Behavioral Health, Inc /ID# 238212

Toms River, New Jersey, 08755-6434, United States

Location

Dent Neurosciences Research Center, Inc. /ID# 237039

Amherst, New York, 14226, United States

Location

Central New York Clinical Research /ID# 235694

Manlius, New York, 13104, United States

Location

Rochester Clinical Research /ID# 236842

New York, New York, 14609, United States

Location

Upstate Clinical Research Associates /ID# 238220

Williamsville, New York, 14221-6046, United States

Location

PMG Research of Charlotte /ID# 237048

Charlotte, North Carolina, 28209, United States

Location

Raleigh Neurology Associates /ID# 237138

Raleigh, North Carolina, 27607, United States

Location

CTI Clinical Research Center /ID# 237278

Cincinnati, Ohio, 45212, United States

Location

University of Cincinnati /ID# 234403

Cincinnati, Ohio, 45267, United States

Location

Aventiv Research Columbus /ID# 236837

Columbus, Ohio, 43213, United States

Location

OK Clinical Research /ID# 236675

Edmond, Oklahoma, 73034-3257, United States

Location

IPS Research Company /ID# 237674

Oklahoma City, Oklahoma, 73106, United States

Location

Summit Headlands LLC /ID# 236077

Portland, Oregon, 97210, United States

Location

Abington Neurological Associates - Abington /ID# 236257

Abington, Pennsylvania, 19001, United States

Location

Lehigh Center for Clinical Research /ID# 236703

Allentown, Pennsylvania, 18104-5034, United States

Location

Suburban Research Associates - Media /ID# 236698

Media, Pennsylvania, 19063-1760, United States

Location

Thomas Jefferson University Jefferson Headache Center /ID# 235821

Philadelphia, Pennsylvania, 19107, United States

Location

Frontier Clinical Research /ID# 237924

Smithfield, Pennsylvania, 15478, United States

Location

Clinical Trials of SC /ID# 237338

Charleston, South Carolina, 29406, United States

Location

WR-ClinSearch /ID# 238287

Chattanooga, Tennessee, 37421-1605, United States

Location

CNS Healthcare - Memphis /ID# 236396

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Neurology /ID# 236428

Austin, Texas, 78731, United States

Location

Tekton Research, Inc. /ID# 237306

Austin, Texas, 78745, United States

Location

DiscoveResearch, Inc /ID# 236273

Bryan, Texas, 77802, United States

Location

FutureSearch Trials of Dallas, LP /ID# 236276

Dallas, Texas, 75231, United States

Location

Centex Studies, Inc. - Houston /ID# 237458

Houston, Texas, 77058, United States

Location

ClinPoint Trials /ID# 236618

Waxahachie, Texas, 75165-1430, United States

Location

Advanced Research Institute /ID# 237749

Ogden, Utah, 84403, United States

Location

University of Utah /ID# 237602

Salt Lake City, Utah, 84112-5500, United States

Location

Charlottesville Medical Research /ID# 237792

Charlottesville, Virginia, 22911, United States

Location

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

Newport News, Virginia, 23606, United States

Location

Tidewater Integr Med Research /ID# 236867

Virginia Beach, Virginia, 23451, United States

Location

Sentara Neurology Specialists - Virginia Beach /ID# 234350

Virginia Beach, Virginia, 23456-0019, United States

Location

Northwest Clinical Research Center /ID# 237585

Bellevue, Washington, 98007, United States

Location

Seattle Clinical Research Center /ID# 236912

Seattle, Washington, 98105, United States

Location

Puget Sound Neurology /ID# 236322

Tacoma, Washington, 25328, United States

Location

Related Publications (4)

• 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.

  PMID: 39982105 DERIVED

• 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.

  PMID: 39399572 DERIVED

• 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.

  PMID: 39197113 DERIVED

• 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.

  PMID: 37979595 DERIVED

Related Links

• Additional information on study locations near you may be found at www.AllerganClinicalTrials.com.

MeSH Terms

Conditions

Migraine Disorders

Interventions

ubrogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: August 21, 2020
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: May 31, 2023
• Results First Posted: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below
• 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.

Locations

US (73)