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) (Ubro Peds)

May 11, 2026 updated by: AbbVie

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1059

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 Contact

Study Locations

  • Puerto Rico
      • Bayamón, Puerto Rico, 00960
        • Completed
        • Clinical Research Investigator Group /ID# 267454
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Puerto Rico Health Institute /ID# 249162
        • Contact:
          • Site Coordinator
          • Phone Number: 787-797-1049
      • San Juan, Puerto Rico, 00918-3501
        • Recruiting
        • CMRC Headlands LLC /ID# 265301
      • San Juan, Puerto Rico, 00917-3104
        • Recruiting
        • GCM Medical Group /ID# 249643
        • Contact:
          • Site Coordinator
          • Phone Number: 787-936-2100
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805-4046
        • Recruiting
        • Rehabilitation & Neurological Services /ID# 229969
      • Saraland, Alabama, United States, 36571
        • Recruiting
        • The Center for Clinical Trials - Saraland /ID# 231546
    • Arizona
    • Arkansas
      • Glenwood, Arkansas, United States, 71943
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • HealthStar Research of Hot Springs PLLC /ID# 273256
        • Contact:
          • Site Coordinator
          • Phone Number: 501-760-2903
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Preferred Research Partners /ID# 230725
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center /ID# 227962
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro Pain Research Center /ID# 227966
      • Long Beach, California, United States, 90807
        • Recruiting
        • Alliance for Research Alliance for Wellness /ID# 230546
      • Los Angeles, California, United States, 90027
        • Completed
        • Children's Hospital Los Angeles /ID# 230596
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research, Inc /ID# 230899
      • San Diego, California, United States, 92108-1681
        • Recruiting
        • Paradigm Clinical Research - San Diego /ID# 269608
        • Contact:
          • Site Coordinator
          • Phone Number: 858-274-4226
      • San Jose, California, United States, 95124-4108
        • Recruiting
        • Lumos Clinical Research Center /ID# 231267
      • Upland, California, United States, 91786
        • Recruiting
        • Pacific Clinical Research Management Group /ID# 231636
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research /ID# 230971
      • Winnetka, California, United States, 91306
        • Recruiting
        • Amicis Research Center /ID# 272621
        • Contact:
          • Site Coordinator
          • Phone Number: 818-924-4708
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado - Aurora /ID# 231879
      • Centennial, Colorado, United States, 80112
        • Completed
        • IMMUNOe Research Centers /ID# 230879
      • Colorado Springs, Colorado, United States, 80910
        • Completed
        • MCB Clinical Research Centers /ID# 231625
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • New England Institute for Clinical Research /ID# 230635
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20009
        • Recruiting
        • Emerson Clinical Research Institute - Washington - Connecticut Avenue /ID# 231693
    • Florida
      • Boynton Beach, Florida, United States, 33436-7245
        • Recruiting
        • Encore Medical Research of Boynton Beach LLC /ID# 246833
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Gulf Coast Clinical Research Center /ID# 230020
      • Gainesville, Florida, United States, 32607
        • Completed
        • Sarkis Clinical Trials /ID# 227956
      • Gulf Breeze, Florida, United States, 32561-4495
        • Completed
        • Northwest Florida Clinical Research Group, LLC /ID# 231069
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • AGA Clinical Trials /ID# 230554
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Encore Medical Research /ID# 245682
        • Contact:
          • Site Coordinator
          • Phone Number: +1-954-400-1725
      • Homestead, Florida, United States, 33030-4613
        • Completed
        • Advanced Research Institute of Miami /ID# 230292
      • Lakeland, Florida, United States, 33813-2768
        • Completed
        • Auzmer Research /ID# 239251
      • Miami, Florida, United States, 33155
        • Recruiting
        • My Preferred Research LLC /ID# 227886
      • Miami, Florida, United States, 33186-7661
        • Completed
        • Neurology & Pain Medicine /ID# 240168
      • Miami, Florida, United States, 33125
        • Recruiting
        • Columbus Clinical Services, Llc /Id# 230880
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Medical Research Group of Central Florida /ID# 231632
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Clinical Associates of Orlando, LLC /ID# 272619
      • Palm Harbor, Florida, United States, 34684
        • Completed
        • Suncoast Clinical Research - Palm Harbor /ID# 229337
      • Spring Hill, Florida, United States, 34609-5692
        • Recruiting
        • Asclepes Research Centers - Spring Hill /ID# 229815
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida- Neuroscience Institute /ID# 229324
      • Weston, Florida, United States, 33331
        • Recruiting
        • Encore Medical Research - Weston /ID# 246809
      • Winter Park, Florida, United States, 32789-7111
        • Recruiting
        • Pediatric Neurology and Epilepsy Specialists /ID# 229967
    • Georgia
      • Atlanta, Georgia, United States, 30318-2512
        • Recruiting
        • Rare Disease Research, LLC /ID# 231046
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
      • Atlanta, Georgia, United States, 30315
        • Completed
        • Treken Primary Care /ID# 240586
      • Brunswick, Georgia, United States, 31520-1601
        • Recruiting
        • Coastal Georgia Child Neurology /ID# 231409
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExcel iResearch LLC /ID# 227903
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Velocity Clinical Research - Savannah. /ID# 228992
      • Stockbridge, Georgia, United States, 30281
        • Completed
        • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Velocity Clinical Research - Boise /ID# 231871
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Chicago Headache Center & Research Institute /ID# 248625
        • Contact:
          • Site Coordinator
          • Phone Number: (773-935-1000)
      • Hoffman Estates, Illinois, United States, 60169
        • Recruiting
        • Ascension Saint Alexius /ID# 275261
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Accellacare - McFarland Clinic /ID# 229789
    • Kansas
      • Overland Park, Kansas, United States, 66221
        • Completed
        • Psychiatric Associates /ID# 230872
      • Overland Park, Kansas, United States, 66210-2761
        • Completed
        • College Park Family Care Center Overland Park /ID# 231456
      • Overland Park, Kansas, United States, 66214
        • Recruiting
        • Clinical Associates Midwest, LLC /ID# 274315
      • Wichita, Kansas, United States, 67207
        • Recruiting
        • Alliance for Multispecialty Research - Wichita East /ID# 234126
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Chandler Medical Center. /ID# 230827
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Recruiting
        • Pharmasite Research, Inc. /ID# 227908
    • Minnesota
      • Burnsville, Minnesota, United States, 55337-6732
        • Recruiting
        • Minneapolis Clinic of Neurology - Burnsville /ID# 232551
    • Mississippi
      • Petal, Mississippi, United States, 39465-2932
        • Completed
        • MediSync Clinical Research Hattiesburg Clinic /ID# 233326
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • Proven Endpoints LLC /ID# 239513
    • Missouri
      • Ozark, Missouri, United States, 65721
        • Recruiting
        • Sharlin Health and Neurology /ID# 229523
    • Nebraska
      • Papillion, Nebraska, United States, 68046-4131
        • Recruiting
        • Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060-3483
        • Recruiting
        • Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
    • New Jersey
      • Annandale, New Jersey, United States, 08801-3127
        • Completed
        • Hunterdon Neurology /ID# 245648
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Goryeb Childrens Hospital /ID# 229507
      • Runnemede, New Jersey, United States, 08078-1034
        • Completed
        • CVS HealthHUB - Runnemede /ID# 234233
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute - Amherst /ID# 231182
      • Mount Kisco, New York, United States, 10549-3028
        • Completed
        • Bioscience Research /ID# 232159
      • New York, New York, United States, 10001
        • Completed
        • Modern Migraine MD /ID# 258081
      • Port Jefferson Station, New York, United States, 11776-3387
        • Completed
        • North Suffolk Neurology /ID# 230956
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University /ID# 239898
    • North Carolina
      • Charlotte, North Carolina, United States, 28210-8905
        • Completed
        • CVS HealthHUB - Charlotte /ID# 239530
      • Hickory, North Carolina, United States, 28601
        • Completed
        • OnSite Clinical Solutions, LLC - Hickory /ID# 227994
    • Ohio
      • Cincinnati, Ohio, United States, 45215-2123
        • Recruiting
        • Patient Priority Clinical Sites, LLC /ID# 238485
      • Cincinnati, Ohio, United States, 45236-1875
        • Recruiting
        • Headache Center of Hope /ID# 242645
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Childrens Hospital Medical Center /ID# 244689
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University Of Cincinnati Medical Center /ID# 231199
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Centricity Research Columbus /ID# 231181
        • Contact:
          • Site Coordinator
          • Phone Number: 614 501 6164
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • CincyScience /ID# 230046
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Completed
        • IPS Research Company /ID# 227961
    • Oregon
      • Portland, Oregon, United States, 97225-6625
        • Recruiting
        • Providence Brain and Spine Institute /ID# 231607
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4319
        • Recruiting
        • Children's Hospital of Philadelphia - Main /ID# 232487
      • Scottdale, Pennsylvania, United States, 15683
        • Recruiting
        • Frontier Clinical Research, LLC - Scottdale /ID# 231913
      • Smithfield, Pennsylvania, United States, 15478
        • Recruiting
        • Frontier Clinical Research - Smithfield /ID# 231912
    • South Carolina
      • Charleston, South Carolina, United States, 29414-5834
        • Completed
        • Coastal Pediatric Research /ID# 238616
      • Greenville, South Carolina, United States, 29607-4021
        • Recruiting
        • Tribe Clinical Research LLC /ID# 230422
      • Greer, South Carolina, United States, 29650
        • Completed
        • Duplicate_Premier Neurology, P.C. /ID# 227999
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Access Clinical Trials, Inc. /ID# 228002
    • Texas
      • Austin, Texas, United States, 78723-3079
        • Recruiting
        • UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
      • Austin, Texas, United States, 78759
        • Recruiting
        • Velocity Clinical Research, Austin /ID# 230557
      • Austin, Texas, United States, 78759
        • Completed
        • BioBehavioral Research of Austin /ID# 230529
      • Austin, Texas, United States, 78726
        • Recruiting
        • Austin Regional Clinic - ARC Four Points /ID# 276301
      • Beaumont, Texas, United States, 77706-3067
        • Recruiting
        • Tekton Research - Beaumont /ID# 231207
      • Dallas, Texas, United States, 75251-2202
        • Recruiting
        • Cedar Health Research /ID# 228003
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Relaro Medical Trials /ID# 239642
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Epic Medical Research - DeSoto /ID# 274314
      • El Paso, Texas, United States, 79925-7945
        • Completed
        • 3A Research - East El Paso /ID# 239193
      • Friendswood, Texas, United States, 77546
        • Completed
        • Earle Research /ID# 231548
      • Friendswood, Texas, United States, 77546
        • Recruiting
        • Innovare Research Group, LLC /ID# 277617
      • Houston, Texas, United States, 77065
        • Recruiting
        • DM Clinical Research /ID# 229826
      • Houston, Texas, United States, 77090-2633
        • Recruiting
        • Houston Clinical Research Associates /ID# 244889
      • Houston, Texas, United States, 77099
        • Recruiting
        • Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316
      • Houston, Texas, United States, 77074
        • Recruiting
        • Aavon Clinical Trials /ID# 279007
      • Kerrville, Texas, United States, 78028-9640
        • Recruiting
        • Sante Clinical Research /ID# 246503
        • Contact:
          • Site Coordinator
          • Phone Number: 830-890-5171
      • Lampasas, Texas, United States, 76550
        • Recruiting
        • FMC Science /ID# 231915
        • Contact:
          • Site Coordinator
          • Phone Number: 512-556-4130
      • Mansfield, Texas, United States, 76063-5622
        • Recruiting
        • Livingspring Family Medical Center /ID# 249869
        • Contact:
          • Site Coordinator
          • Phone Number: (817) 907-7330
      • Plano, Texas, United States, 75093
        • Completed
        • AIM Trials /ID# 230142
      • San Antonio, Texas, United States, 78249-3538
        • Recruiting
        • Road Runner Research /ID# 230527
      • The Woodlands, Texas, United States, 77381
        • Completed
        • Family Psychiatry of The Woodlands /ID# 230163
      • Waxahachie, Texas, United States, 75165-1430
        • Recruiting
        • ClinPoint Trials /ID# 230295
    • Utah
      • Bountiful, Utah, United States, 84010-4968
        • Recruiting
        • Pantheon Clinical Research /ID# 250703
        • Contact:
          • Site Coordinator
          • Phone Number: 385-281-0550
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Highland Clinical Research /ID# 239362
      • Salt Lake City, Utah, United States, 84132
        • Completed
        • University of Utah Health Hospital /ID# 230908
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Completed
        • Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
    • Virginia
      • Franklin, Virginia, United States, 23851
        • Completed
        • Office of Maria Ona /ID# 234232
      • Norfolk, Virginia, United States, 23507-1901
        • Recruiting
        • Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
      • Richmond, Virginia, United States, 23294
        • Completed
        • National Clinical Research /ID# 231320
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Core Clinical Research /ID# 227904
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Institute for Research & Innovation /ID# 231061
        • Contact:
    • West Virginia
      • Kingwood, West Virginia, United States, 26537-9797
        • Recruiting
        • Frontier Clinical Research - Kingwood /ID# 231914
    • Wisconsin
      • Mequon, Wisconsin, United States, 53092
        • Recruiting
        • Mind+ Neurology /ID# 275529
        • Contact:
          • Site Coordinator
          • Phone Number: (888) 585-7975

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

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PK Cohort: Ubrogepant Dose A
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Drug: Ubrogepant
Oral Tablet
Other Names:
  • Ubrelvy
Experimental: PK Cohort: Ubrogepant Dose B
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Drug: Ubrogepant
Oral Tablet
Other Names:
  • Ubrelvy
Experimental: Main Study: Children Ubrogepant Low Dose
Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Drug: Ubrogepant
Oral Tablet
Other Names:
  • Ubrelvy
Experimental: Main Study: Children Ubrogepant High Dose
Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Drug: Ubrogepant
Oral Tablet
Other Names:
  • Ubrelvy
Placebo Comparator: Main Study: Children Ubrogepant Placebo
Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Drug: Placebo-Matching Ubrogepant
Oral Tablet
Experimental: Main Study: Adolescents Ubrogepant Low Dose
Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Drug: Ubrogepant
Oral Tablet
Other Names:
  • Ubrelvy
Experimental: Main Study: Adolescents Ubrogepant High Dose
Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Drug: Ubrogepant
Oral Tablet
Other Names:
  • Ubrelvy
Placebo Comparator: Main Study: Adolescents Ubrogepant Placebo
Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, starting 2 hours after initial dose for headache of moderate/severe intensity.
Drug: Placebo-Matching Ubrogepant
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Time Frame: 2 hours after initial dose
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
2 hours after initial dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with Pain Relief at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
Time Frame: 2 hours after initial dose
Pain Relief is defined as a reduction in headache severity from moderate/severe at baseline to mild or no pain.
2 hours after initial dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose in pediatric participants aged 6 to 17 years
Time Frame: 2 to 24 hours after initial dose
Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug.
2 to 24 hours after initial dose
Percentage of participants that used rescue medication (including a second dose of study intervention) within 24 hours after the initial dose in pediatric participants aged 6 to 17 years
Time Frame: 24 hours after initial dose
24 hours after initial dose
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 6 to 17 years
Time Frame: Baseline (Predose) to 2 hours after initial dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'.
Baseline (Predose) to 2 hours after initial dose
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 12 to 17 years
Time Frame: Baseline (Predose) to 2 hours after initial dose
The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'.
Baseline (Predose) to 2 hours after initial dose
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 11 years
Time Frame: 2 hours after initial dose
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
2 hours after initial dose
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Time Frame: 2 hours after initial dose
Photophobia was defined as sensitivity to light, a migraine-associated symptom.
2 hours after initial dose
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Time Frame: 2 hours after initial dose
Phonophobia was defined as sensitivity to sound, a migraine-associated symptom.
2 hours after initial dose
Percentage of Participants With the Absence of Nausea at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Time Frame: 2 hours after initial dose
Nausea was a migraine-associated symptom.
2 hours after initial dose
Number of Participants with Adverse Events (AE)
Time Frame: Up to 6 months
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to 6 months
Percentage of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed in pediatric participants aged 6 to 17 years
Time Frame: Up to 6 months
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Up to 6 months
Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years
Time Frame: Up to 6 months
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Up to 6 months
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements in pediatric participants aged 6 to 17 years
Time Frame: Up to 6 months
Percentage of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Up to 6 months
Percentage of patients with suicidal ideation or suicidal behavior
Time Frame: Up to 6 months
Up to 6 months
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
Time Frame: 2 hours after initial dose
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to
2 hours after initial dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

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.

Helpful Links

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)

January 13, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3110-305-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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