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New hope for young migraine sufferers: drug trial targets kids as young as 6

NCT ID NCT05125302

Symptom relief Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 14 times

Summary

This study tests an oral medication called ubrogepant, already approved for adults, to see if it safely and effectively treats migraine attacks in children and adolescents aged 6 to 17. About 1,059 participants with a history of migraine will receive either a low or high dose of ubrogepant or a placebo. The main goal is to measure how many become pain-free within 2 hours of taking the drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,059 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months. * By history, the participant's migraines typically last between 3 and 72 hours if untreated 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 in each of the 2 months prior to screening (Visit 1). * Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine. * For main study participants, treatment of a qualifying migraine with single-blind placebo during the screening period and completion of 2-hour headache pain assessment. * Weight is ≥ 20 kg (44 pounds) and \< 135 kg (298 pounds) * Per investigator judgment, participant is able to swallow or can learn to swallow study intervention. * The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian. 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, confounding psychiatric conditions, or other significant neurological disorders other than migraine. * 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 the study intervention. * Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with intent, with or without a plan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior 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 after taking 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 or barbiturates \> 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 in the 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 of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3. * 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 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 be discontinued or switched to an allowable, alternative medication at Visit 1. * Previous exposure, within the last 6 months, to injectable monoclonal antibodies blocking the calcitonin gene-related peptide (CGRP) pathway * History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist or hypersensitivity to any component of the study interventions, ubrogepant or placebo. * Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    91 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    COMPLETED

    El Paso, Texas, 79925-7945, United States

  • AGA Clinical Trials /ID# 230554

    RECRUITING

    Hialeah, Florida, 33012, United States

  • AIM Trials /ID# 230142

    COMPLETED

    Plano, Texas, 75093, United States

  • Aavon Clinical Trials /ID# 279007

    RECRUITING

    Houston, Texas, 77074, United States

  • Accellacare - McFarland Clinic /ID# 229789

    RECRUITING

    Ames, Iowa, 50010, United States

  • Access Clinical Trials, Inc. /ID# 228002

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Advanced Research Center /ID# 227962

    RECRUITING

    Anaheim, California, 92805, United States

  • Advanced Research Institute of Miami /ID# 230292

    COMPLETED

    Homestead, Florida, 33030-4613, United States

  • Alliance For Multispeciality Research - Wichita East /ID# 234126

    RECRUITING

    Wichita, Kansas, 67207, United States

  • Alliance for Research Alliance for Wellness /ID# 230546

    RECRUITING

    Long Beach, California, 90807, United States

  • Amicis Research Center /ID# 272621

    RECRUITING

    Winnetka, California, 91306, United States

  • Ascension Saint Alexius /ID# 275261

    RECRUITING

    Hoffman Estates, Illinois, 60169, United States

  • Austin Regional Clinic - ARC Four Points /ID# 276301

    RECRUITING

    Austin, Texas, 78726, United States

  • Auzmer Research /ID# 239251

    COMPLETED

    Lakeland, Florida, 33813-2768, United States

  • BioBehavioral Research of Austin /ID# 230529

    COMPLETED

    Austin, Texas, 78759, United States

  • CVS HealthHUB - Charlotte /ID# 239530

    COMPLETED

    Charlotte, North Carolina, 28210-8905, United States

  • CVS HealthHUB - Runnemede /ID# 234233

    COMPLETED

    Runnemede, New Jersey, 08078-1034, United States

  • Caribbean Medical Research Center Headlands /ID# 265301

    RECRUITING

    San Juan, 00918-3501, Puerto Rico

  • Cedar Health Research /ID# 228003

    RECRUITING

    Dallas, Texas, 75251-2202, United States

  • CenExcel iResearch LLC /ID# 227903

    COMPLETED

    Decatur, Georgia, 30030, United States

  • Centricity Research Columbus /ID# 231181

    RECRUITING

    Columbus, Ohio, 43213, United States

  • Chicago Headache Center & Research Institute /ID# 248625

    RECRUITING

    Chicago, Illinois, 60657, United States

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

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles /ID# 230596

    COMPLETED

    Los Angeles, California, 90027, United States

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

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4319, United States

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

    RECRUITING

    Norfolk, Virginia, 23507-1901, United States

  • Cincinnati Childrens Hospital Medical Center /ID# 244689

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • CincyScience /ID# 230046

    RECRUITING

    West Chester, Ohio, 45069, United States

  • ClinPoint Trials /ID# 230295

    RECRUITING

    Waxahachie, Texas, 75165-1430, United States

  • Clinical Associates Midwest, LLC /ID# 274315

    RECRUITING

    Overland Park, Kansas, 66214, United States

  • Clinical Associates of Orlando, LLC /ID# 272619

    RECRUITING

    Orlando, Florida, 32819, United States

  • Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Clinical Research Investigator Group /ID# 267454

    COMPLETED

    Bayamón, 00960, Puerto Rico

  • Coastal Georgia Child Neurology /ID# 231409

    RECRUITING

    Brunswick, Georgia, 31520-1601, United States

  • Coastal Pediatric Research /ID# 238616

    COMPLETED

    Charleston, South Carolina, 29414-5834, United States

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

    RECRUITING

    Papillion, Nebraska, 68046-4131, United States

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

    COMPLETED

    Overland Park, Kansas, 66210-2761, United States

  • Columbus Clinical Services, Llc /Id# 230880

    RECRUITING

    Miami, Florida, 33125, United States

  • Core Clinical Research /ID# 227904

    RECRUITING

    Everett, Washington, 98201, United States

  • DM Clinical Research /ID# 229826

    RECRUITING

    Houston, Texas, 77065, United States

  • Dent Neurologic Institute - Amherst /ID# 231182

    RECRUITING

    Amherst, New York, 14226, United States

  • Duplicate_Bioscience Research /ID# 232159

    COMPLETED

    Mount Kisco, New York, 10549-3028, United States

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

    COMPLETED

    Greer, South Carolina, 29650, United States

  • Earle Research /ID# 231548

    COMPLETED

    Friendswood, Texas, 77546, United States

  • Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693

    RECRUITING

    Washington D.C., District of Columbia, 20009, United States

  • Encore Medical Research - Weston /ID# 246809

    RECRUITING

    Weston, Florida, 33331, United States

  • Encore Medical Research /ID# 245682

    RECRUITING

    Hollywood, Florida, 33021, United States

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

    RECRUITING

    Boynton Beach, Florida, 33436-7245, United States

  • Epic Medical Research - DeSoto /ID# 274314

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Excell Research, Inc /ID# 230899

    RECRUITING

    Oceanside, California, 92056, United States

  • FMC Science /ID# 231915

    RECRUITING

    Lampasas, Texas, 76550, United States

  • FWD Clinical Research - Spring Hill /ID# 229815

    RECRUITING

    Spring Hill, Florida, 34609-5692, United States

  • Family Psychiatry of The Woodlands /ID# 230163

    COMPLETED

    The Woodlands, Texas, 77381, United States

  • Frontier Clinical Research - Kingwood /ID# 231914

    RECRUITING

    Kingwood, West Virginia, 26537-9797, United States

  • Frontier Clinical Research - Scottdale /ID# 231913

    RECRUITING

    Scottdale, Pennsylvania, 15683, United States

  • Frontier Clinical Research - Smithfield /ID# 231912

    RECRUITING

    Smithfield, Pennsylvania, 15478, United States

  • GCM Medical Group /ID# 249643

    RECRUITING

    San Juan, 00917-3104, Puerto Rico

  • Goryeb Childrens Hospital /ID# 229507

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Gulf Coast Clinical Research Center /ID# 230020

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Headache Center of Hope /ID# 242645

    RECRUITING

    Cincinnati, Ohio, 45236-1875, United States

  • HealthStar Research Glenwood /ID# 275303

    RECRUITING

    Glenwood, Arkansas, 71943, United States

  • HealthStar Research of Hot Springs /ID# 273256

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

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

    RECRUITING

    Nashua, New Hampshire, 03060-3483, United States

  • Highland Clinical Research /ID# 239362

    RECRUITING

    Salt Lake City, Utah, 84124, United States

  • Houston Clinical Research Associates /ID# 244889

    RECRUITING

    Houston, Texas, 77090-2633, United States

  • Hunterdon Neurology /ID# 245648

    COMPLETED

    Annandale, New Jersey, 08801-3127, United States

  • IMMUNOe Research Centers /ID# 230879

    COMPLETED

    Centennial, Colorado, 80112, United States

  • IPS Research Company /ID# 227961

    COMPLETED

    Oklahoma City, Oklahoma, 73106, United States

  • Imax Clinical Trials /ID# 281436

    RECRUITING

    La Palma, California, 90623, United States

  • Innovare Research Group, LLC /ID# 277617

    RECRUITING

    Friendswood, Texas, 77546, United States

  • Livingspring Family Medical Center /ID# 249869

    RECRUITING

    Mansfield, Texas, 76063-5622, United States

  • Lumos Clinical Research Center /ID# 231267

    RECRUITING

    San Jose, California, 95124-4108, United States

  • MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625

    COMPLETED

    Colorado Springs, Colorado, 80910, United States

  • MediSync Clinical Research Hattiesburg Clinic /ID# 233326

    COMPLETED

    Petal, Mississippi, 39465-2932, United States

  • Medical Research Group of Central Florida /ID# 231632

    RECRUITING

    Orange City, Florida, 32763, United States

  • Mind+ Neurology /ID# 275529

    RECRUITING

    Mequon, Wisconsin, 53092, United States

  • Minneapolis Clinic of Neurology - Burnsville /ID# 232551

    RECRUITING

    Burnsville, Minnesota, 55337-6732, United States

  • Modern Migraine MD /ID# 258081

    COMPLETED

    New York, New York, 10001, United States

  • MultiCare Institute for Research and Innovation /ID# 231061

    RECRUITING

    Tacoma, Washington, 98405, United States

  • My Preferred Research LLC /ID# 227886

    RECRUITING

    Miami, Florida, 33155, United States

  • National Clinical Research /ID# 231320

    COMPLETED

    Richmond, Virginia, 23294, United States

  • Neuro Pain Research Center /ID# 227966

    RECRUITING

    Fresno, California, 93710, United States

  • Neurology & Pain Medicine /ID# 240168

    COMPLETED

    Miami, Florida, 33186-7661, United States

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

    COMPLETED

    Woodstock, Vermont, 05091, United States

  • New England Institute for Clinical Research /ID# 230635

    RECRUITING

    Stamford, Connecticut, 06905, United States

  • North Suffolk Neurology /ID# 230956

    COMPLETED

    Port Jefferson Station, New York, 11776-3387, United States

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

    COMPLETED

    Gulf Breeze, Florida, 32561-4495, United States

  • Office of Maria Ona /ID# 234232

    COMPLETED

    Franklin, Virginia, 23851, United States

  • OnSite Clinical Solutions - Ninth Ave Drive North East - Hickory /ID# 227994

    COMPLETED

    Hickory, North Carolina, 28601, United States

  • Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834

    RECRUITING

    Charlotte, North Carolina, 28277, United States

  • Pacific Clinical Research Management Group /ID# 231636

    COMPLETED

    Upland, California, 91786, United States

  • Pantheon Clinical Research /ID# 250703

    RECRUITING

    Bountiful, Utah, 84010-4968, United States

  • Paradigm Clinical Research - Aurora, CO /ID# 280612

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Paradigm Clinical Research - Modesto, CA /ID# 280611

    RECRUITING

    Modesto, California, 95355, United States

  • Paradigm Clinical Research - San Diego /ID# 269608

    RECRUITING

    San Diego, California, 92108-1681, United States

  • Patient Priority Clinical Sites, LLC /ID# 238485

    RECRUITING

    Cincinnati, Ohio, 45215-2123, United States

  • Pediatric Associates of Charlottesville, PLC /ID# 230628

    RECRUITING

    Charlottesville, Virginia, 22902, United States

  • Pediatric Neurology and Epilepsy Specialists /ID# 229967

    RECRUITING

    Winter Park, Florida, 32789-7111, United States

  • Pharmasite Research, Inc. /ID# 227908

    RECRUITING

    Baltimore, Maryland, 21208, United States

  • Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316

    RECRUITING

    Houston, Texas, 77099, United States

  • Preferred Research Partners /ID# 230725

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Proven Endpoints LLC /ID# 239513

    RECRUITING

    Ridgeland, Mississippi, 39157, United States

  • Providence Brain and Spine Institute /ID# 231607

    RECRUITING

    Portland, Oregon, 97225-6625, United States

  • Psychiatric Associates /ID# 230872

    COMPLETED

    Overland Park, Kansas, 66221, United States

  • Puerto Rico Health Institute /ID# 249162

    RECRUITING

    Dorado, 00646, Puerto Rico

  • Rare Disease Research /ID# 231046

    RECRUITING

    Atlanta, Georgia, 30318-2512, United States

  • Rehabilitation & Neurological Services /ID# 229969

    RECRUITING

    Huntsville, Alabama, 35805-4046, United States

  • Relaro Medical Trials /ID# 239642

    RECRUITING

    Dallas, Texas, 75243, United States

  • Road Runner Research /ID# 230527

    RECRUITING

    San Antonio, Texas, 78249-3538, United States

  • SUNY Upstate Medical University /ID# 239898

    RECRUITING

    Syracuse, New York, 13210, United States

  • Sante Clinical Research /ID# 246503

    RECRUITING

    Kerrville, Texas, 78028-9640, United States

  • Sarkis Clinical Trials /ID# 227956

    COMPLETED

    Gainesville, Florida, 32607, United States

  • Sharlin Health and Neurology /ID# 229523

    COMPLETED

    Ozark, Missouri, 65721, United States

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738

    COMPLETED

    Stockbridge, Georgia, 30281, United States

  • Suncoast Clinical Research - Palm Harbor /ID# 229337

    COMPLETED

    Palm Harbor, Florida, 34684, United States

  • Sunwise Clinical Research /ID# 230971

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Tekton Research - Beaumont /ID# 231207

    COMPLETED

    Beaumont, Texas, 77706-3067, United States

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

    RECRUITING

    Saraland, Alabama, 36571, United States

  • Treken Primary Care /ID# 240586

    COMPLETED

    Atlanta, Georgia, 30315, United States

  • Tribe Clinical Research LLC /ID# 230422

    RECRUITING

    Greenville, South Carolina, 29607-4021, United States

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

    RECRUITING

    Austin, Texas, 78723-3079, United States

  • University Of Cincinnati Medical Center /ID# 231199

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Kentucky Chandler Medical Center /ID# 230827

    RECRUITING

    Lexington, Kentucky, 40536, United States

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

    RECRUITING

    Tampa, Florida, 33613, United States

  • University of Utah Health Hospital /ID# 230908

    COMPLETED

    Salt Lake City, Utah, 84132, United States

  • Velocity Clinical Research - Boise /ID# 231871

    RECRUITING

    Meridian, Idaho, 83642, United States

  • Velocity Clinical Research - Phoenix /ID# 274478

    RECRUITING

    Phoenix, Arizona, 85006, United States

    Contact Email: •••••@•••••

  • Velocity Clinical Research - Savannah. /ID# 228992

    RECRUITING

    Savannah, Georgia, 31406, United States

  • Velocity Clinical Research, Austin /ID# 230557

    RECRUITING

    Austin, Texas, 78759, United States

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