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
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)
1 other identifier
interventional
1,059
2 countries
124
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2022
Typical duration for phase_3
124 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedStudy Start
First participant enrolled
January 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 4, 2026
March 1, 2026
4.3 years
November 8, 2021
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Pain Freedom is defined as a reduction in headache severity from moderate/severe at baseline to no pain.
2 hours after initial dose
Secondary Outcomes (15)
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
2 hours after initial dose
Percentage of participants with Pain Relief at 2 Hours After the Initial Dose in pediatric participants aged 12 to 17 years
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
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
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
Baseline (Predose) to 2 hours after initial dose
- +10 more secondary outcomes
Study Arms (8)
PK Cohort: Ubrogepant Dose A
EXPERIMENTALParticipants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
PK Cohort: Ubrogepant Dose B
EXPERIMENTALParticipants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Main Study: Children Ubrogepant Low Dose
EXPERIMENTALParticipants 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.
Main Study: Children Ubrogepant High Dose
EXPERIMENTALParticipants 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.
Main Study: Children Ubrogepant Placebo
PLACEBO COMPARATORParticipants 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.
Main Study: Adolescents Ubrogepant Low Dose
EXPERIMENTALParticipants 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.
Main Study: Adolescents Ubrogepant High Dose
EXPERIMENTALParticipants 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.
Main Study: Adolescents Ubrogepant Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Oral Tablet
Oral Tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (124)
Rehabilitation & Neurological Services /ID# 229969
Huntsville, Alabama, 35805-4046, United States
The Center for Clinical Trials - Saraland /ID# 231546
Saraland, Alabama, 36571, United States
Velocity Clinical Research - Phoenix /ID# 274478
Phoenix, Arizona, 85006, United States
HealthStar Research Glenwood /ID# 275303
Glenwood, Arkansas, 71943, United States
HealthStar Research of Hot Springs PLLC /ID# 273256
Hot Springs, Arkansas, 71913, United States
Preferred Research Partners /ID# 230725
Little Rock, Arkansas, 72211, United States
Advanced Research Center /ID# 227962
Anaheim, California, 92805, United States
Neuro Pain Research Center /ID# 227966
Fresno, California, 93710, United States
Alliance for Research Alliance for Wellness /ID# 230546
Long Beach, California, 90807, United States
Children's Hospital Los Angeles /ID# 230596
Los Angeles, California, 90027, United States
Excell Research, Inc /ID# 230899
Oceanside, California, 92056, United States
Paradigm Clinical Research - San Diego /ID# 269608
San Diego, California, 92108-1681, United States
Lumos Clinical Research Center /ID# 231267
San Jose, California, 95124-4108, United States
Pacific Clinical Research Management Group /ID# 231636
Upland, California, 91786, United States
Sunwise Clinical Research /ID# 230971
Walnut Creek, California, 94596, United States
Amicis Research Center /ID# 272621
Winnetka, California, 91306, United States
Children's Hospital Colorado - Aurora /ID# 231879
Aurora, Colorado, 80045, United States
IMMUNOe Research Centers /ID# 230879
Centennial, Colorado, 80112, United States
MCB Clinical Research Centers /ID# 231625
Colorado Springs, Colorado, 80910, United States
New England Institute for Clinical Research /ID# 230635
Stamford, Connecticut, 06905, United States
Emerson Clinical Research Institute - Washington - Connecticut Avenue /ID# 231693
Washington D.C., District of Columbia, 20009, United States
Encore Medical Research of Boynton Beach LLC /ID# 246833
Boynton Beach, Florida, 33436-7245, United States
Gulf Coast Clinical Research Center /ID# 230020
Fort Myers, Florida, 33912, United States
Sarkis Clinical Trials /ID# 227956
Gainesville, Florida, 32607, United States
Northwest Florida Clinical Research Group, LLC /ID# 231069
Gulf Breeze, Florida, 32561-4495, United States
AGA Clinical Trials /ID# 230554
Hialeah, Florida, 33012, United States
Encore Medical Research /ID# 245682
Hollywood, Florida, 33021, United States
Advanced Research Institute of Miami /ID# 230292
Homestead, Florida, 33030-4613, United States
Auzmer Research /ID# 239251
Lakeland, Florida, 33813-2768, United States
Columbus Clinical Services, Llc /Id# 230880
Miami, Florida, 33125, United States
My Preferred Research LLC /ID# 227886
Miami, Florida, 33155, United States
Neurology & Pain Medicine /ID# 240168
Miami, Florida, 33186-7661, United States
Medical Research Group of Central Florida /ID# 231632
Orange City, Florida, 32763, United States
Clinical Associates of Orlando, LLC /ID# 272619
Orlando, Florida, 32819, United States
Suncoast Clinical Research - Palm Harbor /ID# 229337
Palm Harbor, Florida, 34684, United States
Asclepes Research Centers - Spring Hill /ID# 229815
Spring Hill, Florida, 34609-5692, United States
University of South Florida- Neuroscience Institute /ID# 229324
Tampa, Florida, 33613, United States
Encore Medical Research - Weston /ID# 246809
Weston, Florida, 33331, United States
Pediatric Neurology and Epilepsy Specialists /ID# 229967
Winter Park, Florida, 32789-7111, United States
Treken Primary Care /ID# 240586
Atlanta, Georgia, 30315, United States
Rare Disease Research, LLC /ID# 231046
Atlanta, Georgia, 30318-2512, United States
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134
Atlanta, Georgia, 30328, United States
Coastal Georgia Child Neurology /ID# 231409
Brunswick, Georgia, 31520-1601, United States
CenExcel iResearch LLC /ID# 227903
Decatur, Georgia, 30030, United States
Velocity Clinical Research - Savannah. /ID# 228992
Savannah, Georgia, 31406, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
Stockbridge, Georgia, 30281, United States
Velocity Clinical Research - Boise /ID# 231871
Meridian, Idaho, 83642, United States
Chicago Headache Center & Research Institute /ID# 248625
Chicago, Illinois, 60657, United States
Ascension Saint Alexius /ID# 275261
Hoffman Estates, Illinois, 60169, United States
Accellacare - McFarland Clinic /ID# 229789
Ames, Iowa, 50010, United States
College Park Family Care Center Overland Park /ID# 231456
Overland Park, Kansas, 66210-2761, United States
Clinical Associates Midwest, LLC /ID# 274315
Overland Park, Kansas, 66214, United States
Psychiatric Associates /ID# 230872
Overland Park, Kansas, 66221, United States
Alliance for Multispecialty Research - Wichita East /ID# 234126
Wichita, Kansas, 67207, United States
University of Kentucky Chandler Medical Center. /ID# 230827
Lexington, Kentucky, 40536, United States
Pharmasite Research, Inc. /ID# 227908
Baltimore, Maryland, 21208, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 232551
Burnsville, Minnesota, 55337-6732, United States
MediSync Clinical Research Hattiesburg Clinic /ID# 233326
Petal, Mississippi, 39465-2932, United States
Proven Endpoints LLC /ID# 239513
Ridgeland, Mississippi, 39157, United States
Sharlin Health and Neurology /ID# 229523
Ozark, Missouri, 65721, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 232552
Papillion, Nebraska, 68046-4131, United States
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312
Nashua, New Hampshire, 03060-3483, United States
Hunterdon Neurology /ID# 245648
Annandale, New Jersey, 08801-3127, United States
Goryeb Childrens Hospital /ID# 229507
Morristown, New Jersey, 07960, United States
CVS HealthHUB - Runnemede /ID# 234233
Runnemede, New Jersey, 08078-1034, United States
Dent Neurologic Institute - Amherst /ID# 231182
Amherst, New York, 14226, United States
Bioscience Research /ID# 232159
Mount Kisco, New York, 10549-3028, United States
Modern Migraine MD /ID# 258081
New York, New York, 10001, United States
North Suffolk Neurology /ID# 230956
Port Jefferson Station, New York, 11776-3387, United States
SUNY Upstate Medical University /ID# 239898
Syracuse, New York, 13210, United States
CVS HealthHUB - Charlotte /ID# 239530
Charlotte, North Carolina, 28210-8905, United States
OnSite Clinical Solutions, LLC - Hickory /ID# 227994
Hickory, North Carolina, 28601, United States
Patient Priority Clinical Sites, LLC /ID# 238485
Cincinnati, Ohio, 45215-2123, United States
University Of Cincinnati Medical Center /ID# 231199
Cincinnati, Ohio, 45219, United States
Cincinnati Childrens Hospital Medical Center /ID# 244689
Cincinnati, Ohio, 45229, United States
Headache Center of Hope /ID# 242645
Cincinnati, Ohio, 45236-1875, United States
Centricity Research Columbus /ID# 231181
Columbus, Ohio, 43213, United States
CincyScience /ID# 230046
West Chester, Ohio, 45069, United States
IPS Research Company /ID# 227961
Oklahoma City, Oklahoma, 73106, United States
Providence Brain and Spine Institute /ID# 231607
Portland, Oregon, 97225-6625, United States
Children's Hospital of Philadelphia - Main /ID# 232487
Philadelphia, Pennsylvania, 19104-4319, United States
Frontier Clinical Research, LLC - Scottdale /ID# 231913
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research - Smithfield /ID# 231912
Smithfield, Pennsylvania, 15478, United States
Coastal Pediatric Research /ID# 238616
Charleston, South Carolina, 29414-5834, United States
Tribe Clinical Research LLC /ID# 230422
Greenville, South Carolina, 29607-4021, United States
Duplicate_Premier Neurology, P.C. /ID# 227999
Greer, South Carolina, 29650, United States
Access Clinical Trials, Inc. /ID# 228002
Nashville, Tennessee, 37203, United States
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266
Austin, Texas, 78723-3079, United States
Austin Regional Clinic - ARC Four Points /ID# 276301
Austin, Texas, 78726, United States
BioBehavioral Research of Austin /ID# 230529
Austin, Texas, 78759, United States
Velocity Clinical Research, Austin /ID# 230557
Austin, Texas, 78759, United States
Tekton Research - Beaumont /ID# 231207
Beaumont, Texas, 77706-3067, United States
Relaro Medical Trials /ID# 239642
Dallas, Texas, 75243, United States
Cedar Health Research /ID# 228003
Dallas, Texas, 75251-2202, United States
Epic Medical Research - DeSoto /ID# 274314
DeSoto, Texas, 75115, United States
3A Research - East El Paso /ID# 239193
El Paso, Texas, 79925-7945, United States
Earle Research /ID# 231548
Friendswood, Texas, 77546, United States
Innovare Research Group, LLC /ID# 277617
Friendswood, Texas, 77546, United States
DM Clinical Research /ID# 229826
Houston, Texas, 77065, United States
Aavon Clinical Trials /ID# 279007
Houston, Texas, 77074, United States
Houston Clinical Research Associates /ID# 244889
Houston, Texas, 77090-2633, United States
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316
Houston, Texas, 77099, United States
Sante Clinical Research /ID# 246503
Kerrville, Texas, 78028-9640, United States
FMC Science /ID# 231915
Lampasas, Texas, 76550, United States
Livingspring Family Medical Center /ID# 249869
Mansfield, Texas, 76063-5622, United States
AIM Trials /ID# 230142
Plano, Texas, 75093, United States
Road Runner Research /ID# 230527
San Antonio, Texas, 78249-3538, United States
Family Psychiatry of The Woodlands /ID# 230163
The Woodlands, Texas, 77381, United States
ClinPoint Trials /ID# 230295
Waxahachie, Texas, 75165-1430, United States
Pantheon Clinical Research /ID# 250703
Bountiful, Utah, 84010-4968, United States
Highland Clinical Research /ID# 239362
Salt Lake City, Utah, 84124, United States
University of Utah Health Hospital /ID# 230908
Salt Lake City, Utah, 84132, United States
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976
Woodstock, Vermont, 05091, United States
Office of Maria Ona /ID# 234232
Franklin, Virginia, 23851, United States
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581
Norfolk, Virginia, 23507-1901, United States
National Clinical Research /ID# 231320
Richmond, Virginia, 23294, United States
Core Clinical Research /ID# 227904
Everett, Washington, 98201, United States
MultiCare Institute for Research & Innovation /ID# 231061
Tacoma, Washington, 98405, United States
Frontier Clinical Research - Kingwood /ID# 231914
Kingwood, West Virginia, 26537-9797, United States
Mind+ Neurology /ID# 275529
Mequon, Wisconsin, 53092, United States
Clinical Research Investigator Group, LLC /ID# 267454
Bayamón, 00960, Puerto Rico
Puerto Rico Health Institute /ID# 249162
Dorado, 00646, Puerto Rico
GCM Medical Group PSC /ID# 249643
San Juan, 00917-3104, Puerto Rico
CMRC Headlands LLC /ID# 265301
San Juan, 00918-3501, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
November 18, 2021
Study Start
January 13, 2022
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.