Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
UBRO PEDS OLE
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
1 other identifier
interventional
1,200
2 countries
113
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 long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States. Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks. 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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events 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
Longer than P75 for phase_3
113 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 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
January 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
July 20, 2025
July 1, 2025
6 years
November 9, 2021
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Percentage of Participants with Adverse Events (AEs)
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 54 weeks
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
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 54 Weeks
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Up to 54 Weeks
Percentage of Participants with Potentially Clinically Significant lab values
Percentage of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Up to 54 Weeks
Percentage of with Participants with Suicidal Ideation or Suicidal Behavior
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).
Up to 54 Weeks
Percentage of Participants with Change in Menstrual Cycle
Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.
Up to 54 Weeks
Change from baseline in Tanner staging score
Tanner's staging is used to assess growth and pubertal development.
Up to 54 Weeks
Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties
up to 54 weeks
Study Arms (2)
Ubrogepant Dose A (12 to 17 Years Old)
EXPERIMENTALParticipants will receive oral tablets of ubrogepant Dose A for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.
Ubrogepant Dose B (6 to 11 Years Old)
EXPERIMENTALParticipants will receive the highest dose of oral tablets of ubrogepant tested in Study 3110-305-002 for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, at least 2 hours after initial dose for headache of any intensity.
Interventions
Oral Tablet
Eligibility Criteria
You may qualify if:
- Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.
- Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.
You may not qualify if:
- 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.
- An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.
- Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.
- Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1
- Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (113)
Rehabilitation & Neurological Services /ID# 240054
Huntsville, Alabama, 35805-4046, United States
The Center for Clinical Trials - Saraland /ID# 239448
Saraland, Alabama, 36571, United States
Preferred Research Partners /ID# 238979
Little Rock, Arkansas, 72211, United States
Advanced Research Center /ID# 238967
Anaheim, California, 92805, United States
Neuro Pain Medical Center /ID# 239135
Fresno, California, 93710, United States
Alliance for Research Alliance for Wellness /ID# 233497
Long Beach, California, 90807, United States
Children's Hospital Los Angeles /ID# 239446
Los Angeles, California, 90027, United States
Excell Research, Inc /ID# 233495
Oceanside, California, 92056, United States
Paradigm Clinical Research - San Diego /ID# 269611
San Diego, California, 92108-1681, United States
Lumos Clinical Research Center /ID# 239018
San Jose, California, 95124-4108, United States
Pacific Clinical Research Management Group /ID# 238503
Upland, California, 91786, United States
Sunwise Clinical Research /ID# 238458
Walnut Creek, California, 94596, United States
Children's Hospital Colorado - Aurora /ID# 239838
Aurora, Colorado, 80045, United States
IMMUNOe Research Centers /ID# 240846
Centennial, Colorado, 80112, United States
MCB Clinical Research Centers /ID# 240999
Colorado Springs, Colorado, 80910, United States
New England Institute for Clinical Research /ID# 239019
Stamford, Connecticut, 06905, United States
Emerson Clinical Research Inst /ID# 238455
Washington D.C., District of Columbia, 20011, United States
Encore Medical Research of Boynton Beach LLC /ID# 248720
Boynton Beach, Florida, 33436-7245, United States
Gulf Coast Clinical Research Center /ID# 233335
Fort Myers, Florida, 33912, United States
Sarkis Clinical Trials /ID# 233493
Gainesville, Florida, 32607, United States
Northwest Florida Clinical Research Group, LLC /ID# 244396
Gulf Breeze, Florida, 32561-4495, United States
A.G.A Clinical Trials /ID# 238409
Hialeah, Florida, 33012, United States
Encore Medical Research /ID# 247463
Hollywood, Florida, 33021, United States
Advanced Research Institute of Miami /ID# 240712
Homestead, Florida, 33030-4613, United States
Auzmer Research /ID# 241514
Lakeland, Florida, 33813-2768, United States
Columbus Clinical Services, Llc /Id# 238968
Miami, Florida, 33125, United States
My Preferred Research LLC /ID# 239020
Miami, Florida, 33155, United States
Neurology & Pain Medicine /ID# 241860
Miami, Florida, 33186-7661, United States
Medical Research Group of Central Florida /ID# 240711
Orange City, Florida, 32763, United States
Clinical Associates of Orlando, LLC /ID# 272623
Orlando, Florida, 32819, United States
Suncoast Clinical Research - Palm Harbor /ID# 233535
Palm Harbor, Florida, 34684, United States
Asclepes Research Centers - Spring Hill /ID# 231872
Spring Hill, Florida, 34609-5692, United States
University of South Florida- Neuroscience Institute /ID# 233420
Tampa, Florida, 33613, United States
Encore Medical Research - Weston /ID# 248335
Weston, Florida, 33331, United States
Pediatric Neurology and Epilepsy Specialists /ID# 233336
Winter Park, Florida, 32789-7111, United States
Global Research Associates /ID# 243504
Atlanta, Georgia, 30315, United States
Rare Disease Research, LLC /ID# 238833
Atlanta, Georgia, 30318-2512, United States
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
Atlanta, Georgia, 30328, United States
Coastal Georgia Child Neurology /ID# 240845
Brunswick, Georgia, 31520-1601, United States
CenExcel iResearch LLC /ID# 239832
Decatur, Georgia, 30030, United States
Velocity Clinical Research - Savannah /ID# 231873
Savannah, Georgia, 31406, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
Stockbridge, Georgia, 30281, United States
Velocity Clinical Research - Boise /ID# 238978
Meridian, Idaho, 83642, United States
Chicago Headache Center & Research Institute /ID# 254071
Chicago, Illinois, 60657, United States
Accellacare - McFarland Clinic /ID# 238490
Ames, Iowa, 50010, United States
College Park Family Care Center Overland Park /ID# 240707
Overland Park, Kansas, 66210-2761, United States
Clinical Associates Midwest, LLC /ID# 274356
Overland Park, Kansas, 66214, United States
Psychiatric Associates /ID# 240710
Overland Park, Kansas, 66221, United States
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
Wichita, Kansas, 67205-1138, United States
University of Kentucky Chandler Medical Center /ID# 233428
Lexington, Kentucky, 40536, United States
Pharmasite Research, Inc. /ID# 233414
Baltimore, Maryland, 21208, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 238828
Burnsville, Minnesota, 55337-6732, United States
MediSync Clinical Research Hattiesburg Clinic /ID# 239837
Petal, Mississippi, 39465-2932, United States
Proven Endpoints LLC /ID# 240974
Ridgeland, Mississippi, 39157, United States
Sharlin Health Neuroscience Research Center /ID# 238969
Ozark, Missouri, 65721-5315, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
Papillion, Nebraska, 68046-4131, United States
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
Nashua, New Hampshire, 03060-3483, United States
Hunterdon Neurology /ID# 248222
Annandale, New Jersey, 08801-3127, United States
Goryeb Children's Hospital /ID# 239425
Morristown, New Jersey, 07960, United States
CVS HealthHUB - Runnemede /ID# 240057
Runnemede, New Jersey, 08078-1034, United States
Dent Neurologic Institute - Amherst /ID# 238415
Amherst, New York, 14226, United States
Bioscience Research /ID# 239442
Mount Kisco, New York, 10549-3028, United States
Modern Migraine MD /ID# 263140
New York, New York, 10001, United States
North Suffolk Neurology /ID# 238457
Port Jefferson Station, New York, 11776-3387, United States
SUNY Upstate Medical University /ID# 241140
Syracuse, New York, 13210, United States
CVS HealthHUB - Charlotte /ID# 240842
Charlotte, North Carolina, 28210-8905, United States
OnSite Clinical Solutions, LLC - Hickory /ID# 238946
Hickory, North Carolina, 28601, United States
Patient Priority Clinical Sites, LLC /ID# 240051
Cincinnati, Ohio, 45215-2123, United States
University of Cincinnati /ID# 238461
Cincinnati, Ohio, 45219, United States
Cincinnati Childrens Hospital Medical Center /ID# 247491
Cincinnati, Ohio, 45229, United States
Headache Center of Hope /ID# 244819
Cincinnati, Ohio, 45236-1875, United States
Centricity Research Columbus /ID# 238832
Columbus, Ohio, 43213, United States
CincyScience /ID# 233334
West Chester, Ohio, 45069, United States
IPS Research Company /ID# 231876
Oklahoma City, Oklahoma, 73106, United States
Providence Brain and Spine Institute /ID# 240050
Portland, Oregon, 97225-6625, United States
Children's Hospital of Philadelphia - Main /ID# 241138
Philadelphia, Pennsylvania, 19104-4319, United States
Frontier Clinical Research, LLC - Scottdale /ID# 239017
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research - Smithfield /ID# 238502
Smithfield, Pennsylvania, 15478, United States
Coastal Pediatric Research /ID# 240708
Charleston, South Carolina, 29414-5834, United States
Tribe Clinical Research LLC /ID# 239143
Greenville, South Carolina, 29607-4021, United States
Duplicate_Premier Neurology, P.C. /ID# 233419
Greer, South Carolina, 29650, United States
Access Clinical Trials, Inc. /ID# 238414
Nashville, Tennessee, 37203, United States
UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
Austin, Texas, 78723-3079, United States
BioBehavioral Research of Austin /ID# 233427
Austin, Texas, 78759, United States
Velocity Clinical Research, Austin /ID# 233406
Austin, Texas, 78759, United States
Tekton Research - Beaumont /ID# 238407
Beaumont, Texas, 77706-3067, United States
Relaro Medical Trials /ID# 241141
Dallas, Texas, 75243, United States
Cedar Health Research /ID# 233403
Dallas, Texas, 75251-2202, United States
3A Research - East El Paso /ID# 241665
El Paso, Texas, 79925-7945, United States
Earle Research /ID# 238940
Friendswood, Texas, 77546, United States
DM Clinical Research /ID# 238361
Houston, Texas, 77065, United States
Houston Clinical Research Associates /ID# 246522
Houston, Texas, 77090-2633, United States
Sante Clinical Research /ID# 248333
Kerrville, Texas, 78028-9640, United States
FMC Science /ID# 240475
Lampasas, Texas, 76550, United States
Livingspring Family Medical Center /ID# 252194
Mansfield, Texas, 76063-5622, United States
AIM Trials /ID# 233425
Plano, Texas, 75093, United States
Road Runner Research /ID# 238360
San Antonio, Texas, 78249-3538, United States
Family Psychiatry of The Woodlands /ID# 238980
The Woodlands, Texas, 77381, United States
ClinPoint Trials /ID# 238406
Waxahachie, Texas, 75165-1430, United States
Pantheon Clinical Research /ID# 251475
Bountiful, Utah, 84010-4968, United States
Highland Clinical Research /ID# 240053
Salt Lake City, Utah, 84124, United States
University of Utah Health Hospital /ID# 239021
Salt Lake City, Utah, 84132, United States
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
Woodstock, Vermont, 05091, United States
Office of Maria Ona /ID# 239833
Franklin, Virginia, 23851, United States
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
Norfolk, Virginia, 23507-1901, United States
National Clinical Research /ID# 238419
Richmond, Virginia, 23294, United States
Core Clinical Research /ID# 233421
Everett, Washington, 98201, United States
Frontier Clinical Research - Kingwood /ID# 238459
Kingwood, West Virginia, 26537-9797, United States
Mind+ Neurology /ID# 275538
Mequon, Wisconsin, 53092, United States
Clinical Research Investigator Group, LLC /ID# 267458
Bayamón, 00960, Puerto Rico
Puerto Rico Health Institute /ID# 250560
Dorado, 00646, Puerto Rico
GCM Medical Group PSC /ID# 250561
San Juan, 00917-3104, Puerto Rico
Caribbean Medical Research Center /ID# 265292
San Juan, 00918-3501, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2021
First Posted
November 19, 2021
Study Start
January 14, 2022
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.