Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)

Last updated: April 7, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Pain

Migraine (Adult)

Oral Facial Pain

Treatment

Ubrogepant

Placebo-Matching Ubrogepant

Clinical Study ID

NCT05125302
3110-305-002
  • Ages 6-17
  • All Genders

Study Summary

Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents.

Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment.

For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A history of migraine with or without aura consistent with a diagnosis according tothe International Classification of Headache Disorders (ICHD-3) for at least 6months.

  • By history, the participant's migraines typically last between 3 and 72 hours ifuntreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.

  • History of 1 to 14 migraine attacks per month with moderate to severe headache ineach of the 2 months prior to screening (Visit 1).

  • Current or past use of at least 1 oral medication (over-the-counter medication orprescription medication) for the acute treatment of migraine.

  • For main study participants, treatment of a qualifying migraine with single-blindplacebo during the screening period and completion of 2-hour headache painassessment.

  • Weight is ≥ 20 kg (44 pounds) and < 135 kg (298 pounds)

  • Per investigator judgment, participant is able to swallow or can learn to swallowstudy intervention.

  • The participant is able to understand and complete the study questionnaires andeDiary. Participants who need assistance with reading the assessments may beassisted by a parent or guardian.

Exclusion

Exclusion Criteria:

  • Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic,gastrointestinal, cardiovascular or neurologic disease.

  • In the opinion of the investigator, other confounding pain syndromes, confoundingpsychiatric conditions, or other significant neurological disorders other thanmigraine.

  • History of malignancy in the 5 years prior to Visit 1.

  • History of any prior gastrointestinal conditions (eg, diarrhea syndromes,inflammatory bowel disease) that may affect the absorption or metabolism of thestudy intervention.

  • Significant risk of self-harm, based on clinical interview and responses on theColumbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participantsmust be excluded if they report suicidal ideation with intent, with or without aplan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidalbehavior in the last 6 months prior to Visit 1 or Visit 2 assessments.

  • At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.

  • For main study participants, no headache at the 2-hour post dose assessment aftertaking single-blind placebo for a qualifying migraine during screening period (ie,placebo responder).

  • A current diagnosis of chronic migraine as defined by ICHD-3

  • Participants who overuse medication for migraine defined as use of opioids orbarbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month or any combination of triptans,ergots, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 10 days/month inthe 3 months prior to Visit 1 per investigator's judgment.

  • Difficulty distinguishing migraine headache from tension-type or other headaches.

  • Has a history of migraine aura with diplopia or impairment of level ofconsciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.

  • Has a current diagnosis of new persistent daily headache, trigeminal autonomiccephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3

  • Required in-hospital (excluding emergency department visits) treatment for migraines 3 or more times in the 6 months prior to Visit 1.

  • Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice)that is on the list of prohibited concomitant medications that cannot bediscontinued or switched to an allowable, alternative medication at Visit 1.

  • Previous exposure, within the last 6 months, to injectable monoclonal antibodiesblocking the calcitonin gene-related peptide (CGRP) pathway

  • History of hypersensitivity or clinically significant adverse reaction to a CGRPreceptor antagonist or hypersensitivity to any component of the study interventions,ubrogepant or placebo.

  • Currently participating or has participated in a study with an investigationalcompound or device within 30 days prior to Visit 1

Study Design

Total Participants: 1059
Treatment Group(s): 2
Primary Treatment: Ubrogepant
Phase: 3
Study Start date:
January 13, 2022
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Clinical Research Investigator Group, LLC /ID# 267454

    Bayamon, 00960
    Puerto Rico

    Active - Recruiting

  • Puerto Rico Health Institute /ID# 249162

    Dorado, 00646
    Puerto Rico

    Active - Recruiting

  • Ponce Medical School Foundation /ID# 250612

    Ponce, 00716-0377
    Puerto Rico

    Site Not Available

  • Caribbean Medical Research Center /ID# 265301

    San Juan, 00918-3501
    Puerto Rico

    Active - Recruiting

  • GCM Medical Group PSC /ID# 249643

    San Juan, 00917-3104
    Puerto Rico

    Active - Recruiting

  • Rehabilitation & Neurological Services /ID# 229969

    Huntsville, Alabama 35805-4046
    United States

    Active - Recruiting

  • The Center for Clinical Trials - Saraland /ID# 231546

    Saraland, Alabama 36571
    United States

    Active - Recruiting

  • Preferred Research Partners /ID# 230725

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Advanced Research Center /ID# 227962

    Anaheim, California 92805
    United States

    Active - Recruiting

  • Neuro Pain Medical Center /ID# 227966

    Fresno, California 93710-5473
    United States

    Active - Recruiting

  • Sunwise Clinical Research /ID# 230971

    Lafayette, California 94549-4579
    United States

    Site Not Available

  • Alliance for Research - Long Beach /ID# 230546

    Long Beach, California 90807
    United States

    Active - Recruiting

  • Alliance for Research Alliance for Wellness /ID# 230546

    Long Beach, California 90807
    United States

    Active - Recruiting

  • Children's Hospital Los Angeles /ID# 230596

    Los Angeles, California 90027
    United States

    Completed

  • Excell Research, Inc /ID# 230899

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Paradigm Clinical Research - San Diego /ID# 269608

    San Diego, California 92108-1681
    United States

    Active - Recruiting

  • Rady Children's Hospital San Diego /ID# 243201

    San Diego, California 92123
    United States

    Site Not Available

  • Lumos Clinical Research Center /ID# 231267

    San Jose, California 95124-4108
    United States

    Active - Recruiting

  • Pacific Clinical Research Management Group /ID# 231636

    Upland, California 91786
    United States

    Active - Recruiting

  • Sunwise Clinical Research /ID# 230971

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • Children's Hospital Colorado - Aurora /ID# 231879

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Children's Hospital Colorado /ID# 231879

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • IMMUNOe Research Centers /ID# 230879

    Centennial, Colorado 80112
    United States

    Completed

  • MCB Clinical Research Centers /ID# 231625

    Colorado Springs, Colorado 80910
    United States

    Completed

  • Velocity Clinical Research - Denver /ID# 232035

    Denver, Colorado 80209-3804
    United States

    Site Not Available

  • New England Institute for Clinical Research /ID# 230635

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Emerson Clinical Research Inst /ID# 231693

    Washington, District of Columbia 20011
    United States

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  • Encore Medical Research of Boynton Beach LLC /ID# 246833

    Boynton Beach, Florida 33436-7245
    United States

    Active - Recruiting

  • Gulf Coast Clinical Research Center /ID# 230020

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Gulfcoast Clinical Research Center /ID# 230020

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Sarkis Clinical Trials /ID# 227956

    Gainesville, Florida 32607
    United States

    Completed

  • Northwest Florida Clinical Research Group, LLC /ID# 231069

    Gulf Breeze, Florida 32561-4495
    United States

    Completed

  • A.G.A Clinical Trials /ID# 230554

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Encore Medical Research /ID# 245682

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Encore Medical Research LLC /ID# 245682

    Hollywood, Florida 33021-6476
    United States

    Active - Recruiting

  • Advanced Research Institute of Miami /ID# 230292

    Homestead, Florida 33030-4613
    United States

    Active - Recruiting

  • Multi-Speciality Research Associates /ID# 229595

    Lake City, Florida 32055-8835
    United States

    Site Not Available

  • Auzmer Research /ID# 239251

    Lakeland, Florida 33813-2768
    United States

    Active - Recruiting

  • Columbus Clinical Services, Llc /Id# 230880

    Miami, Florida 33125-5114
    United States

    Active - Recruiting

  • My Preferred Research LLC /ID# 227886

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Neurology & Pain Medicine /ID# 240168

    Miami, Florida 33186-7661
    United States

    Completed

  • Medical Research Group of Central Florida /ID# 231632

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Clinical Associates of Orlando, LLC /ID# 272619

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Suncoast Clinical Research - Palm Harbor /ID# 229337

    Palm Harbor, Florida 34684
    United States

    Active - Recruiting

  • Bioresearch Institute LLC /ID# 230909

    Pembroke Pines, Florida 33026-4383
    United States

    Site Not Available

  • South Florida Urgent Care - Pembroke Pines /ID# 239977

    Pembroke Pines, Florida 33029-2818
    United States

    Site Not Available

  • Asclepes Research Centers - Spring Hill /ID# 229815

    Spring Hill, Florida 34609-5692
    United States

    Active - Recruiting

  • Segal Trials - West Broward Outpatient Research Site /ID# 231930

    Tamarac, Florida 33319-4985
    United States

    Site Not Available

  • University of South Florida /ID# 229324

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • University of South Florida- Neuroscience Institute /ID# 229324

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Encore Medical Research - Weston /ID# 246809

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Encore Medical Research of Weston LLC /ID# 246809

    Weston, Florida 33331-3642
    United States

    Active - Recruiting

  • Pediatric Neurology and Epilepsy Specialists /ID# 229967

    Winter Park, Florida 32789-7111
    United States

    Active - Recruiting

  • Pediatrix Medical Group of Florida /ID# 229967

    Winter Park, Florida 32789-7111
    United States

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    Atlanta, Georgia 30328
    United States

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    Atlanta, Georgia 30318-2512
    United States

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    Atlanta, Georgia 30315
    United States

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    Brunswick, Georgia 31520-1601
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    Active - Recruiting

  • CenExcel iResearch LLC /ID# 227903

    Decatur, Georgia 30030
    United States

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  • Meridian Clinical Research LLC /ID# 228992

    Savannah, Georgia 31406
    United States

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    Savannah, Georgia 31406
    United States

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    Stockbridge, Georgia 30281
    United States

    Completed

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    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Chicago Headache Center & Research Institute /ID# 248625

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • Accellacare - McFarland Clinic /ID# 229789

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • Accellacare /ID# 229789

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • College Park Family Care Center Overland Park /ID# 231456

    Overland Park, Kansas 66210-2761
    United States

    Completed

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    Overland Park, Kansas 66221
    United States

    Completed

  • Alliance for Multispecialty Research (AMR) - Wichita West /ID# 234126

    Wichita, Kansas 67205-1138
    United States

    Active - Recruiting

  • University of Kentucky Chandler Medical Center /ID# 230827

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Pharmasite Research, Inc. /ID# 227908

    Baltimore, Maryland 21208
    United States

    Active - Recruiting

  • Michigan Headache & Neurological Institute (MHNI) /ID# 229150

    Ann Arbor, Michigan 48104-5131
    United States

    Site Not Available

  • NeuroBehavioral Medicine Group /ID# 231149

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology - Burnsville /ID# 232551

    Burnsville, Minnesota 55337-6732
    United States

    Active - Recruiting

  • Clinical Research Institute, Inc /ID# 227872

    Minneapolis, Minnesota 55402-2606
    United States

    Site Not Available

  • MediSync Clinical Research Hattiesburg Clinic /ID# 233326

    Petal, Mississippi 39465-2932
    United States

    Completed

  • Proven Endpoints LLC /ID# 239513

    Ridgeland, Mississippi 39157
    United States

    Active - Recruiting

  • Sharlin Health Neuroscience Research Center /ID# 229523

    Ozark, Missouri 65721-5315
    United States

    Active - Recruiting

  • Cognitive Clinical Trials (CCT) - Papillion /ID# 232552

    Papillion, Nebraska 68046-4131
    United States

    Active - Recruiting

  • Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312

    Nashua, New Hampshire 03060-3483
    United States

    Active - Recruiting

  • Hunterdon Neurology /ID# 245648

    Annandale, New Jersey 08801-3127
    United States

    Completed

  • Goryeb Children's Hospital /ID# 229507

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • CVS HealthHUB - Runnemede /ID# 234233

    Runnemede, New Jersey 08078-1034
    United States

    Completed

  • Dent Neurologic Institute - Amherst /ID# 231182

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Dent Neurosciences Research Center, Inc. /ID# 231182

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Bioscience Research /ID# 232159

    Mount Kisco, New York 10549-3028
    United States

    Active - Recruiting

  • Modern Migraine MD /ID# 258081

    New York, New York 10001
    United States

    Active - Recruiting

  • North Suffolk Neurology /ID# 230956

    Port Jefferson Station, New York 11776-3387
    United States

    Completed

  • SUNY Upstate Medical University /ID# 239898

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • CVS HealthHUB - Charlotte /ID# 239530

    Charlotte, North Carolina 28210-8905
    United States

    Completed

  • OnSite Clinical Solutions, LLC - Hickory /ID# 227994

    Hickory, North Carolina 28601
    United States

    Completed

  • Cincinnati Childrens Hospital Medical Center /ID# 244689

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Headache Center of Hope /ID# 242645

    Cincinnati, Ohio 45236-1875
    United States

    Active - Recruiting

  • Patient Priority Clinical Sites, LLC /ID# 238485

    Cincinnati, Ohio 45215-2123
    United States

    Active - Recruiting

  • University Of Cincinnati Medical Center /ID# 231199

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University of Cincinnati /ID# 231199

    Cincinnati, Ohio 45267-0585
    United States

    Active - Recruiting

  • Centricity Research Columbus /ID# 231181

    Columbus, Ohio 43213
    United States

    Active - Recruiting

  • CincyScience /ID# 230046

    West Chester, Ohio 45069
    United States

    Active - Recruiting

  • IPS Research Company /ID# 227961

    Oklahoma City, Oklahoma 73106
    United States

    Completed

  • Providence Brain and Spine Institute /ID# 231607

    Portland, Oregon 97225-6625
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia - Main /ID# 232487

    Philadelphia, Pennsylvania 19104-4319
    United States

    Active - Recruiting

  • Frontier Clinical Research, LLC - Scottdale /ID# 231913

    Scottdale, Pennsylvania 15683
    United States

    Active - Recruiting

  • Frontier Clinical Research /ID# 231912

    Smithfield, Pennsylvania 15478
    United States

    Active - Recruiting

  • Coastal Pediatric Research /ID# 238616

    Charleston, South Carolina 29414-5834
    United States

    Active - Recruiting

  • Tribe Clinical Research LLC /ID# 230422

    Greenville, South Carolina 29607-4021
    United States

    Active - Recruiting

  • Duplicate_Premier Neurology, P.C. /ID# 227999

    Greer, South Carolina 29650
    United States

    Completed

  • Premier Neurology, P.C. /ID# 227999

    Greer, South Carolina 29650
    United States

    Completed

  • Memphis Neurology - Germantown /ID# 245284

    Germantown, Tennessee 38138-1751
    United States

    Site Not Available

  • Le Bonheur Children's Hospital /ID# 244715

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Access Clinical Trials, Inc. /ID# 228002

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • BioBehavioral Research of Austin /ID# 230529

    Austin, Texas 78759
    United States

    Completed

  • UT Health Austin at Dell Children's Neurology Clinic /ID# 244266

    Austin, Texas 78723-3079
    United States

    Active - Recruiting

  • Velocity Clinical Research, Austin /ID# 230557

    Austin, Texas 78759
    United States

    Active - Recruiting

  • Tekton Research - Beaumont /ID# 231207

    Beaumont, Texas 77706-3067
    United States

    Active - Recruiting

  • Velocity Clinical Research - Austin /ID# 230557

    Cedar Park, Texas 78613-3513
    United States

    Site Not Available

  • Cedar Health Research /ID# 228003

    Dallas, Texas 75251-2202
    United States

    Active - Recruiting

  • Relaro Medical Trials /ID# 239642

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • 3A Research - East El Paso /ID# 239193

    El Paso, Texas 79925-7945
    United States

    Active - Recruiting

  • Earle Research /ID# 231548

    Friendswood, Texas 77546
    United States

    Completed

  • DM Clinical Research /ID# 229826

    Houston, Texas 77065
    United States

    Active - Recruiting

  • Houston Clinical Research Associates /ID# 244889

    Houston, Texas 77090-2633
    United States

    Active - Recruiting

  • Research Trials Worldwide /ID# 230896

    Humble, Texas 77338-3501
    United States

    Site Not Available

  • Sante Clinical Research /ID# 246503

    Kerrville, Texas 78028-9640
    United States

    Active - Recruiting

  • FMC Science /ID# 231915

    Lampasas, Texas 76550
    United States

    Active - Recruiting

  • Livingspring Family Medical Center /ID# 249869

    Mansfield, Texas 76063-5622
    United States

    Active - Recruiting

  • AIM Trials /ID# 230142

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Road Runner Research /ID# 230527

    San Antonio, Texas 78249-3538
    United States

    Active - Recruiting

  • Family Psychiatry of The Woodlands /ID# 230163

    The Woodlands, Texas 77381
    United States

    Active - Recruiting

  • ClinPoint Trials /ID# 230295

    Waxahachie, Texas 75165-1430
    United States

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  • Pantheon Clinical Research /ID# 250703

    Bountiful, Utah 84010-4968
    United States

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  • Highland Clinical Research /ID# 239362

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    United States

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  • University of Utah Health Hospital /ID# 230908

    Salt Lake City, Utah 84132
    United States

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  • University of Utah School of Medicine /ID# 230908

    Salt Lake City, Utah 84132-0002
    United States

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  • Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976

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  • Office of Maria Ona /ID# 234232

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  • Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581

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  • National Clinical Research /ID# 231320

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