Taking people in United StatesPhase 3

Tests ubrogepant tablets for acute migraine in children and teens

Tests ubrogepant tablets for migraine attacks in children and adolescents aged 6 to 17.

Plain-language title generated from the registry record
Registry title: 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)

Key facts

Where: Ames, Amherst, Anaheim, Annandale, Atlanta, Aurora, Austin, Baltimore, Beaumont, Bountiful, Boynton Beach, Brunswick, Burnsville, Centennial, Charleston, Charlotte, Charlottesville, Chicago, Cincinnati, Colorado Springs, Columbus, Dallas, Decatur, DeSoto, El Paso, Everett, Fort Myers, Franklin, Fresno, Friendswood, Gainesville, Glenwood, Greenville, Greer, Gulf Breeze, Hialeah, Hickory, Hoffman Estates, Hollywood, Homestead, Hot Springs, Houston, Huntsville, Kerrville, Kingwood, La Palma, Lakeland, Lampasas, Lexington, Little Rock, Long Beach, Los Angeles, Mansfield, Mequon, Meridian, Miami, Modesto, Morristown, Mount Kisco, Nashua, Nashville, New York, Norfolk, Oceanside, Oklahoma City, Orange City, Orlando, Overland Park, Ozark, Palm Harbor, Papillion, Petal, Philadelphia, Phoenix, Plano, Port Jefferson Station, Portland, Richmond, Ridgeland, Runnemede, Salt Lake City, San Antonio, San Diego, San Jose, Saraland, Savannah, Scottdale, Smithfield, Spring Hill, Stamford, Stockbridge, Syracuse, Tacoma, Tampa, The Woodlands, Upland, Walnut Creek, Washington D.C., Waxahachie, West Chester, Weston, Wichita, Winnetka, Winter Park, and Woodstock, United StatesSee the 125 sites
Phase: Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 6 and 17 years old?

Source: NCT05125302, who can take part

Where in United States

Accellacare - McFarland Clinic /ID# 229789Ames, United StatesTaking people
Dent Neurologic Institute - Amherst /ID# 231182Amherst, United StatesTaking people
Advanced Research Center /ID# 227962Anaheim, United StatesTaking people
Hunterdon Neurology /ID# 245648Annandale, United StatesNo longer taking part
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134Atlanta, United StatesTaking people
Rare Disease Research /ID# 231046Atlanta, United StatesTaking people
Treken Primary Care /ID# 240586Atlanta, United StatesNo longer taking part
Children's Hospital Colorado - Aurora /ID# 231879Aurora, United StatesTaking people
Paradigm Clinical Research - Aurora, CO /ID# 280612Aurora, United StatesTaking people
Austin Regional Clinic - ARC Four Points /ID# 276301Austin, United StatesTaking people
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266Austin, United StatesTaking people
Velocity Clinical Research, Austin /ID# 230557Austin, United StatesTaking people
BioBehavioral Research of Austin /ID# 230529Austin, United StatesNo longer taking part
Pharmasite Research, Inc. /ID# 227908Baltimore, United StatesTaking people
Tekton Research - Beaumont /ID# 231207Beaumont, United StatesNo longer taking part
Pantheon Clinical Research /ID# 250703Bountiful, United StatesTaking people
Encore Medical Research of Boynton Beach LLC /ID# 246833Boynton Beach, United StatesTaking people
Coastal Georgia Child Neurology /ID# 231409Brunswick, United StatesTaking people
Minneapolis Clinic of Neurology - Burnsville /ID# 232551Burnsville, United StatesTaking people
IMMUNOe Research Centers /ID# 230879Centennial, United StatesNo longer taking part
Coastal Pediatric Research /ID# 238616Charleston, United StatesNo longer taking part
Onsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834Charlotte, United StatesTaking people
CVS HealthHUB - Charlotte /ID# 239530Charlotte, United StatesNo longer taking part
Pediatric Associates of Charlottesville, PLC /ID# 230628Charlottesville, United StatesTaking people
Chicago Headache Center & Research Institute /ID# 248625Chicago, United StatesTaking people
Cincinnati Childrens Hospital Medical Center /ID# 244689Cincinnati, United StatesTaking people
Headache Center of Hope /ID# 242645Cincinnati, United StatesTaking people
Patient Priority Clinical Sites, LLC /ID# 238485Cincinnati, United StatesTaking people
University Of Cincinnati Medical Center /ID# 231199Cincinnati, United StatesTaking people
MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625Colorado Springs, United StatesNo longer taking part
Centricity Research Columbus /ID# 231181Columbus, United StatesTaking people
Cedar Health Research /ID# 228003Dallas, United StatesTaking people
Relaro Medical Trials /ID# 239642Dallas, United StatesTaking people
CenExcel iResearch LLC /ID# 227903Decatur, United StatesNo longer taking part
Epic Medical Research - DeSoto /ID# 274314DeSoto, United StatesTaking people
3A Research - East El Paso /ID# 239193El Paso, United StatesNo longer taking part
Core Clinical Research /ID# 227904Everett, United StatesTaking people
Gulf Coast Clinical Research Center /ID# 230020Fort Myers, United StatesTaking people
Office of Maria Ona /ID# 234232Franklin, United StatesNo longer taking part
Neuro Pain Research Center /ID# 227966Fresno, United StatesTaking people
Innovare Research Group, LLC /ID# 277617Friendswood, United StatesTaking people
Earle Research /ID# 231548Friendswood, United StatesNo longer taking part
Sarkis Clinical Trials /ID# 227956Gainesville, United StatesNo longer taking part
HealthStar Research Glenwood /ID# 275303Glenwood, United StatesTaking people
Tribe Clinical Research LLC /ID# 230422Greenville, United StatesTaking people
Duplicate_Premier Neurology, P.C. /ID# 227999Greer, United StatesNo longer taking part
Northwest Florida Clinical Research Group, LLC /ID# 231069Gulf Breeze, United StatesNo longer taking part
AGA Clinical Trials /ID# 230554Hialeah, United StatesTaking people
OnSite Clinical Solutions - Ninth Ave Drive North East - Hickory /ID# 227994Hickory, United StatesNo longer taking part
Ascension Saint Alexius /ID# 275261Hoffman Estates, United StatesTaking people
Encore Medical Research /ID# 245682Hollywood, United StatesTaking people
Advanced Research Institute of Miami /ID# 230292Homestead, United StatesNo longer taking part
HealthStar Research of Hot Springs /ID# 273256Hot Springs, United StatesTaking people
Aavon Clinical Trials /ID# 279007Houston, United StatesTaking people
DM Clinical Research /ID# 229826Houston, United StatesTaking people
Houston Clinical Research Associates /ID# 244889Houston, United StatesTaking people
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316Houston, United StatesTaking people
Rehabilitation & Neurological Services /ID# 229969Huntsville, United StatesTaking people
Sante Clinical Research /ID# 246503Kerrville, United StatesTaking people
Frontier Clinical Research - Kingwood /ID# 231914Kingwood, United StatesTaking people
Imax Clinical Trials /ID# 281436La Palma, United StatesTaking people
Auzmer Research /ID# 239251Lakeland, United StatesNo longer taking part
FMC Science /ID# 231915Lampasas, United StatesTaking people
University of Kentucky Chandler Medical Center /ID# 230827Lexington, United StatesTaking people
Preferred Research Partners /ID# 230725Little Rock, United StatesTaking people
Alliance for Research Alliance for Wellness /ID# 230546Long Beach, United StatesTaking people
Children's Hospital Los Angeles /ID# 230596Los Angeles, United StatesNo longer taking part
Livingspring Family Medical Center /ID# 249869Mansfield, United StatesTaking people
Mind+ Neurology /ID# 275529Mequon, United StatesTaking people
Velocity Clinical Research - Boise /ID# 231871Meridian, United StatesTaking people
Columbus Clinical Services, Llc /Id# 230880Miami, United StatesTaking people
My Preferred Research LLC /ID# 227886Miami, United StatesTaking people
Neurology & Pain Medicine /ID# 240168Miami, United StatesNo longer taking part
Paradigm Clinical Research - Modesto, CA /ID# 280611Modesto, United StatesTaking people
Goryeb Childrens Hospital /ID# 229507Morristown, United StatesTaking people
Duplicate_Bioscience Research /ID# 232159Mount Kisco, United StatesNo longer taking part
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312Nashua, United StatesTaking people
Access Clinical Trials, Inc. /ID# 228002Nashville, United StatesTaking people
Modern Migraine MD /ID# 258081New York, United StatesNo longer taking part
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581Norfolk, United StatesTaking people
Excell Research, Inc /ID# 230899Oceanside, United StatesTaking people
IPS Research Company /ID# 227961Oklahoma City, United StatesNo longer taking part
Medical Research Group of Central Florida /ID# 231632Orange City, United StatesTaking people
Clinical Associates of Orlando, LLC /ID# 272619Orlando, United StatesTaking people
Clinical Associates Midwest, LLC /ID# 274315Overland Park, United StatesTaking people
College Park Family Care Center Overland Park /ID# 231456Overland Park, United StatesNo longer taking part
Psychiatric Associates /ID# 230872Overland Park, United StatesNo longer taking part
Sharlin Health and Neurology /ID# 229523Ozark, United StatesNo longer taking part
Suncoast Clinical Research - Palm Harbor /ID# 229337Palm Harbor, United StatesNo longer taking part
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552Papillion, United StatesTaking people
MediSync Clinical Research Hattiesburg Clinic /ID# 233326Petal, United StatesNo longer taking part
Children's Hospital of Philadelphia - Main /ID# 232487Philadelphia, United StatesTaking people
Velocity Clinical Research - Phoenix /ID# 274478Phoenix, United StatesTaking people
AIM Trials /ID# 230142Plano, United StatesNo longer taking part
North Suffolk Neurology /ID# 230956Port Jefferson Station, United StatesNo longer taking part
Providence Brain and Spine Institute /ID# 231607Portland, United StatesTaking people
National Clinical Research /ID# 231320Richmond, United StatesNo longer taking part
Proven Endpoints LLC /ID# 239513Ridgeland, United StatesTaking people
CVS HealthHUB - Runnemede /ID# 234233Runnemede, United StatesNo longer taking part
Highland Clinical Research /ID# 239362Salt Lake City, United StatesTaking people
University of Utah Health Hospital /ID# 230908Salt Lake City, United StatesNo longer taking part
Road Runner Research /ID# 230527San Antonio, United StatesTaking people
Paradigm Clinical Research - San Diego /ID# 269608San Diego, United StatesTaking people
Lumos Clinical Research Center /ID# 231267San Jose, United StatesTaking people
The Center for Clinical Trials - Saraland /ID# 231546Saraland, United StatesTaking people
Velocity Clinical Research - Savannah. /ID# 228992Savannah, United StatesTaking people
Frontier Clinical Research - Scottdale /ID# 231913Scottdale, United StatesTaking people
Frontier Clinical Research - Smithfield /ID# 231912Smithfield, United StatesTaking people
FWD Clinical Research - Spring Hill /ID# 229815Spring Hill, United StatesTaking people
New England Institute for Clinical Research /ID# 230635Stamford, United StatesTaking people
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738Stockbridge, United StatesNo longer taking part
SUNY Upstate Medical University /ID# 239898Syracuse, United StatesTaking people
MultiCare Institute for Research and Innovation /ID# 231061Tacoma, United StatesTaking people
University of South Florida- Neuroscience Institute /ID# 229324Tampa, United StatesTaking people
Family Psychiatry of The Woodlands /ID# 230163The Woodlands, United StatesNo longer taking part
Pacific Clinical Research Management Group /ID# 231636Upland, United StatesNo longer taking part
Sunwise Clinical Research /ID# 230971Walnut Creek, United StatesTaking people
Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693Washington D.C., United StatesTaking people
ClinPoint Trials /ID# 230295Waxahachie, United StatesTaking people
CincyScience /ID# 230046West Chester, United StatesTaking people
Encore Medical Research - Weston /ID# 246809Weston, United StatesTaking people
Alliance For Multispeciality Research - Wichita East /ID# 234126Wichita, United StatesTaking people
Amicis Research Center /ID# 272621Winnetka, United StatesTaking people
Pediatric Neurology and Epilepsy Specialists /ID# 229967Winter Park, United StatesTaking people
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976Woodstock, United StatesNo longer taking part

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Print a page for my doctor

Trial details

Who runs it: AbbVie
Trial code: NCT05125302
Record updated: 14 September 2026
Original description: 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.Read full original descriptionShow less
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
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.
Inclusion: 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: 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; 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; 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; Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1; 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; Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3; 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; 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; Difficulty distinguishing migraine headache from tension-type or other headaches; Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3.
ClinicalTrials.gov NCT05125302