MigrainePhase 3UBRO PEDS OLENCT05127954
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)
A Phase 3 study testing Ubrogepant in people with Migraine, run by AbbVie at 113 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Ubrogepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 113 sitesin 2 countries
- Study dates
- 14 Jan 2022to Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
113 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
113 sites in 2 countries
United States109 sites
Accellacare - McFarland Clinic /ID# 238490
Ames, Iowa, 50010
Dent Neurologic Institute - Amherst /ID# 238415
Amherst, New York, 14226
Advanced Research Center /ID# 238967
Anaheim, California, 92805
Hunterdon Neurology /ID# 248222
Annandale, New Jersey, 08801-3127
Global Research Associates /ID# 243504
Atlanta, Georgia, 30315
Rare Disease Research, LLC /ID# 238833
Atlanta, Georgia, 30318-2512
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
Atlanta, Georgia, 30328
Children's Hospital Colorado - Aurora /ID# 239838
Aurora, Colorado, 80045
UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
Austin, Texas, 78723-3079
BioBehavioral Research of Austin /ID# 233427
Austin, Texas, 78759
Velocity Clinical Research, Austin /ID# 233406
Austin, Texas, 78759
Pharmasite Research, Inc. /ID# 233414
Baltimore, Maryland, 21208
Tekton Research - Beaumont /ID# 238407
Beaumont, Texas, 77706-3067
Pantheon Clinical Research /ID# 251475
Bountiful, Utah, 84010-4968
Encore Medical Research of Boynton Beach LLC /ID# 248720
Boynton Beach, Florida, 33436-7245
Coastal Georgia Child Neurology /ID# 240845
Brunswick, Georgia, 31520-1601
Minneapolis Clinic of Neurology - Burnsville /ID# 238828
Burnsville, Minnesota, 55337-6732
IMMUNOe Research Centers /ID# 240846
Centennial, Colorado, 80112
Coastal Pediatric Research /ID# 240708
Charleston, South Carolina, 29414-5834
CVS HealthHUB - Charlotte /ID# 240842
Charlotte, North Carolina, 28210-8905
Chicago Headache Center & Research Institute /ID# 254071
Chicago, Illinois, 60657
Patient Priority Clinical Sites, LLC /ID# 240051
Cincinnati, Ohio, 45215-2123
University of Cincinnati /ID# 238461
Cincinnati, Ohio, 45219
Cincinnati Childrens Hospital Medical Center /ID# 247491
Cincinnati, Ohio, 45229
Headache Center of Hope /ID# 244819
Cincinnati, Ohio, 45236-1875
MCB Clinical Research Centers /ID# 240999
Colorado Springs, Colorado, 80910
Centricity Research Columbus /ID# 238832
Columbus, Ohio, 43213
Relaro Medical Trials /ID# 241141
Dallas, Texas, 75243
Cedar Health Research /ID# 233403
Dallas, Texas, 75251-2202
CenExcel iResearch LLC /ID# 239832
Decatur, Georgia, 30030
3A Research - East El Paso /ID# 241665
El Paso, Texas, 79925-7945
Core Clinical Research /ID# 233421
Everett, Washington, 98201
Gulf Coast Clinical Research Center /ID# 233335
Fort Myers, Florida, 33912
Office of Maria Ona /ID# 239833
Franklin, Virginia, 23851
Neuro Pain Medical Center /ID# 239135
Fresno, California, 93710
Earle Research /ID# 238940
Friendswood, Texas, 77546
Sarkis Clinical Trials /ID# 233493
Gainesville, Florida, 32607
Tribe Clinical Research LLC /ID# 239143
Greenville, South Carolina, 29607-4021
Duplicate_Premier Neurology, P.C. /ID# 233419
Greer, South Carolina, 29650
Northwest Florida Clinical Research Group, LLC /ID# 244396
Gulf Breeze, Florida, 32561-4495
A.G.A Clinical Trials /ID# 238409
Hialeah, Florida, 33012
OnSite Clinical Solutions, LLC - Hickory /ID# 238946
Hickory, North Carolina, 28601
Encore Medical Research /ID# 247463
Hollywood, Florida, 33021
Advanced Research Institute of Miami /ID# 240712
Homestead, Florida, 33030-4613
DM Clinical Research /ID# 238361
Houston, Texas, 77065
Houston Clinical Research Associates /ID# 246522
Houston, Texas, 77090-2633
Rehabilitation & Neurological Services /ID# 240054
Huntsville, Alabama, 35805-4046
Sante Clinical Research /ID# 248333
Kerrville, Texas, 78028-9640
Frontier Clinical Research - Kingwood /ID# 238459
Kingwood, West Virginia, 26537-9797
Auzmer Research /ID# 241514
Lakeland, Florida, 33813-2768
FMC Science /ID# 240475
Lampasas, Texas, 76550
University of Kentucky Chandler Medical Center /ID# 233428
Lexington, Kentucky, 40536
Preferred Research Partners /ID# 238979
Little Rock, Arkansas, 72211
Alliance for Research Alliance for Wellness /ID# 233497
Long Beach, California, 90807
Children's Hospital Los Angeles /ID# 239446
Los Angeles, California, 90027
Livingspring Family Medical Center /ID# 252194
Mansfield, Texas, 76063-5622
Mind+ Neurology /ID# 275538
Mequon, Wisconsin, 53092
Velocity Clinical Research - Boise /ID# 238978
Meridian, Idaho, 83642
Columbus Clinical Services, Llc /Id# 238968
Miami, Florida, 33125
My Preferred Research LLC /ID# 239020
Miami, Florida, 33155
Neurology & Pain Medicine /ID# 241860
Miami, Florida, 33186-7661
Goryeb Children's Hospital /ID# 239425
Morristown, New Jersey, 07960
Bioscience Research /ID# 239442
Mount Kisco, New York, 10549-3028
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
Nashua, New Hampshire, 03060-3483
Access Clinical Trials, Inc. /ID# 238414
Nashville, Tennessee, 37203
Modern Migraine MD /ID# 263140
New York, New York, 10001
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
Norfolk, Virginia, 23507-1901
Excell Research, Inc /ID# 233495
Oceanside, California, 92056
IPS Research Company /ID# 231876
Oklahoma City, Oklahoma, 73106
Medical Research Group of Central Florida /ID# 240711
Orange City, Florida, 32763
Clinical Associates of Orlando, LLC /ID# 272623
Orlando, Florida, 32819
College Park Family Care Center Overland Park /ID# 240707
Overland Park, Kansas, 66210-2761
Clinical Associates Midwest, LLC /ID# 274356
Overland Park, Kansas, 66214
Psychiatric Associates /ID# 240710
Overland Park, Kansas, 66221
Sharlin Health Neuroscience Research Center /ID# 238969
Ozark, Missouri, 65721-5315
Suncoast Clinical Research - Palm Harbor /ID# 233535
Palm Harbor, Florida, 34684
Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
Papillion, Nebraska, 68046-4131
MediSync Clinical Research Hattiesburg Clinic /ID# 239837
Petal, Mississippi, 39465-2932
Children's Hospital of Philadelphia - Main /ID# 241138
Philadelphia, Pennsylvania, 19104-4319
AIM Trials /ID# 233425
Plano, Texas, 75093
North Suffolk Neurology /ID# 238457
Port Jefferson Station, New York, 11776-3387
Providence Brain and Spine Institute /ID# 240050
Portland, Oregon, 97225-6625
National Clinical Research /ID# 238419
Richmond, Virginia, 23294
Proven Endpoints LLC /ID# 240974
Ridgeland, Mississippi, 39157
CVS HealthHUB - Runnemede /ID# 240057
Runnemede, New Jersey, 08078-1034
Highland Clinical Research /ID# 240053
Salt Lake City, Utah, 84124
University of Utah Health Hospital /ID# 239021
Salt Lake City, Utah, 84132
Road Runner Research /ID# 238360
San Antonio, Texas, 78249-3538
Paradigm Clinical Research - San Diego /ID# 269611
San Diego, California, 92108-1681
Lumos Clinical Research Center /ID# 239018
San Jose, California, 95124-4108
The Center for Clinical Trials - Saraland /ID# 239448
Saraland, Alabama, 36571
Velocity Clinical Research - Savannah /ID# 231873
Savannah, Georgia, 31406
Frontier Clinical Research, LLC - Scottdale /ID# 239017
Scottdale, Pennsylvania, 15683
Frontier Clinical Research - Smithfield /ID# 238502
Smithfield, Pennsylvania, 15478
Asclepes Research Centers - Spring Hill /ID# 231872
Spring Hill, Florida, 34609-5692
New England Institute for Clinical Research /ID# 239019
Stamford, Connecticut, 06905
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
Stockbridge, Georgia, 30281
SUNY Upstate Medical University /ID# 241140
Syracuse, New York, 13210
University of South Florida- Neuroscience Institute /ID# 233420
Tampa, Florida, 33613
Family Psychiatry of The Woodlands /ID# 238980
The Woodlands, Texas, 77381
Pacific Clinical Research Management Group /ID# 238503
Upland, California, 91786
Sunwise Clinical Research /ID# 238458
Walnut Creek, California, 94596
Emerson Clinical Research Inst /ID# 238455
Washington D.C., District of Columbia, 20011
ClinPoint Trials /ID# 238406
Waxahachie, Texas, 75165-1430
CincyScience /ID# 233334
West Chester, Ohio, 45069
Encore Medical Research - Weston /ID# 248335
Weston, Florida, 33331
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
Wichita, Kansas, 67205-1138
Pediatric Neurology and Epilepsy Specialists /ID# 233336
Winter Park, Florida, 32789-7111
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
Woodstock, Vermont, 05091
Puerto Rico4 sites
Clinical Research Investigator Group, LLC /ID# 267458
Bayamón, 00960
Puerto Rico Health Institute /ID# 250560
Dorado, 00646
GCM Medical Group PSC /ID# 250561
San Juan, 00917-3104
Caribbean Medical Research Center /ID# 265292
San Juan, 00918-3501
About this study
Official title: 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)
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.
Read more
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.
- Conditions
- Migraine
- Being tested
- Ubrogepant
- Keywords
- Migraine, Ubrogepant, Ubrelvy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbrogepantDrug
Also called Ubrelvy
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Ubrogepant Dose A (12 to 17 Years Old) | Experimental | Participants 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. Receives: Drug: Ubrogepant |
| Ubrogepant Dose B (6 to 11 Years Old) | Experimental | Participants 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. Receives: Drug: Ubrogepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 54 Weeks
Change from baseline in Tanner staging score
Tanner's staging is used to assess growth and pubertal development.
Measured: 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
Measured: up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start14 Jan 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127954
- Sponsor's protocol ID
- 3110-306-002
- Acronym
- UBRO PEDS OLE
- Status last verified
- Jul 2025
- First submitted
- 9 Nov 2021
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.