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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Migraine
• Intervention / Treatment: Drug: Ubrogepant

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamon, Puerto Rico, 00960
    • Clinical Research Investigator Group, LLC /ID# 267458
  • Dorado, Puerto Rico, 00646
    • Puerto Rico Health Institute /ID# 250560
  • San Juan, Puerto Rico, 00917-3104
    • GCM Medical Group PSC /ID# 250561
  • San Juan, Puerto Rico, 00918-3501
    • Caribbean Medical Research Center /ID# 265292
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805-4046
      • Rehabilitation & Neurological Services /ID# 240054
    • Saraland, Alabama, United States, 36571
      • The Center for Clinical Trials - Saraland /ID# 239448
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners /ID# 238979
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center /ID# 238967
    • Fresno, California, United States, 93710
      • Neuro Pain Medical Center /ID# 239135
    • Long Beach, California, United States, 90807
      • Alliance for Research Alliance for Wellness /ID# 233497
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles /ID# 239446
    • Oceanside, California, United States, 92056
      • Excell Research, Inc /ID# 233495
    • San Diego, California, United States, 92108-1681
      • Paradigm Clinical Research - San Diego /ID# 269611
    • San Jose, California, United States, 95124-4108
      • Lumos Clinical Research Center /ID# 239018
    • Upland, California, United States, 91786
      • Pacific Clinical Research Management Group /ID# 238503
    • Walnut Creek, California, United States, 94596
      • Sunwise Clinical Research /ID# 238458
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado - Aurora /ID# 239838
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers /ID# 240846
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers /ID# 240999
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Clinical Research /ID# 239019
  • District of Columbia
    • Washington, District of Columbia, United States, 20011
      • Emerson Clinical Research Inst /ID# 238455
  • Florida
    • Boynton Beach, Florida, United States, 33436-7245
      • Encore Medical Research of Boynton Beach LLC /ID# 248720
    • Fort Myers, Florida, United States, 33912
      • Gulf Coast Clinical Research Center /ID# 233335
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials /ID# 233493
    • Gulf Breeze, Florida, United States, 32561-4495
      • Northwest Florida Clinical Research Group, LLC /ID# 244396
    • Hialeah, Florida, United States, 33012
      • A.G.A Clinical Trials /ID# 238409
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research /ID# 247463
    • Homestead, Florida, United States, 33030-4613
      • Advanced Research Institute of Miami /ID# 240712
    • Lakeland, Florida, United States, 33813-2768
      • Auzmer Research /ID# 241514
    • Miami, Florida, United States, 33186-7661
      • Neurology & Pain Medicine /ID# 241860
    • Miami, Florida, United States, 33155
      • My Preferred Research LLC /ID# 239020
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services, Llc /Id# 238968
    • Orange City, Florida, United States, 32763
      • Medical Research Group of Central Florida /ID# 240711
    • Orlando, Florida, United States, 32819
      • Clinical Associates of Orlando, LLC /ID# 272623
    • Palm Harbor, Florida, United States, 34684
      • Suncoast Clinical Research - Palm Harbor /ID# 233535
    • Spring Hill, Florida, United States, 34609-5692
      • Asclepes Research Centers - Spring Hill /ID# 231872
    • Tampa, Florida, United States, 33613
      • University of South Florida- Neuroscience Institute /ID# 233420
    • Weston, Florida, United States, 33331
      • Encore Medical Research - Weston /ID# 248335
    • Winter Park, Florida, United States, 32789-7111
      • Pediatric Neurology and Epilepsy Specialists /ID# 233336
  • Georgia
    • Atlanta, Georgia, United States, 30318-2512
      • Rare Disease Research, LLC /ID# 238833
    • Atlanta, Georgia, United States, 30328
      • Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
    • Atlanta, Georgia, United States, 30315
      • Global Research Associates /ID# 243504
    • Brunswick, Georgia, United States, 31520-1601
      • Coastal Georgia Child Neurology /ID# 240845
    • Decatur, Georgia, United States, 30030
      • CenExcel iResearch LLC /ID# 239832
    • Savannah, Georgia, United States, 31406
      • Velocity Clinical Research - Savannah /ID# 231873
    • Stockbridge, Georgia, United States, 30281
      • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research - Boise /ID# 238978
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center & Research Institute /ID# 254071
  • Iowa
    • Ames, Iowa, United States, 50010
      • Accellacare - McFarland Clinic /ID# 238490
  • Kansas
    • Overland Park, Kansas, United States, 66210-2761
      • College Park Family Care Center Overland Park /ID# 240707
    • Overland Park, Kansas, United States, 66221
      • Psychiatric Associates /ID# 240710
    • Overland Park, Kansas, United States, 66214
      • Clinical Associates Midwest, LLC /ID# 274356
    • Wichita, Kansas, United States, 67205-1138
      • Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 233428
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc. /ID# 233414
  • Minnesota
    • Burnsville, Minnesota, United States, 55337-6732
      • Minneapolis Clinic of Neurology - Burnsville /ID# 238828
  • Mississippi
    • Petal, Mississippi, United States, 39465-2932
      • MediSync Clinical Research Hattiesburg Clinic /ID# 239837
    • Ridgeland, Mississippi, United States, 39157
      • Proven Endpoints LLC /ID# 240974
  • Missouri
    • Ozark, Missouri, United States, 65721-5315
      • Sharlin Health Neuroscience Research Center /ID# 238969
  • Nebraska
    • Papillion, Nebraska, United States, 68046-4131
      • Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060-3483
      • Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
  • New Jersey
    • Annandale, New Jersey, United States, 08801-3127
      • Hunterdon Neurology /ID# 248222
    • Morristown, New Jersey, United States, 07960
      • Goryeb Children's Hospital /ID# 239425
    • Runnemede, New Jersey, United States, 08078-1034
      • CVS HealthHUB - Runnemede /ID# 240057
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurologic Institute - Amherst /ID# 238415
    • Mount Kisco, New York, United States, 10549-3028
      • Bioscience Research /ID# 239442
    • New York, New York, United States, 10001
      • Modern Migraine MD /ID# 263140
    • Port Jefferson Station, New York, United States, 11776-3387
      • North Suffolk Neurology /ID# 238457
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University /ID# 241140
  • North Carolina
    • Charlotte, North Carolina, United States, 28210-8905
      • CVS HealthHUB - Charlotte /ID# 240842
    • Hickory, North Carolina, United States, 28601
      • OnSite Clinical Solutions, LLC - Hickory /ID# 238946
  • Ohio
    • Cincinnati, Ohio, United States, 45215-2123
      • Patient Priority Clinical Sites, LLC /ID# 240051
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati /ID# 238461
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center /ID# 247491
    • Cincinnati, Ohio, United States, 45236-1875
      • Headache Center of Hope /ID# 244819
    • Columbus, Ohio, United States, 43213
      • Centricity Research Columbus /ID# 238832
    • West Chester, Ohio, United States, 45069
      • CincyScience /ID# 233334
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company /ID# 231876
  • Oregon
    • Portland, Oregon, United States, 97225-6625
      • Providence Brain and Spine Institute /ID# 240050
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4319
      • Children's Hospital of Philadelphia - Main /ID# 241138
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research, LLC - Scottdale /ID# 239017
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research - Smithfield /ID# 238502
  • South Carolina
    • Charleston, South Carolina, United States, 29414-5834
      • Coastal Pediatric Research /ID# 240708
    • Greenville, South Carolina, United States, 29607-4021
      • Tribe Clinical Research LLC /ID# 239143
    • Greer, South Carolina, United States, 29650
      • Duplicate_Premier Neurology, P.C. /ID# 233419
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Access Clinical Trials, Inc. /ID# 238414
  • Texas
    • Austin, Texas, United States, 78723-3079
      • UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
    • Austin, Texas, United States, 78759
      • BioBehavioral Research of Austin /ID# 233427
    • Austin, Texas, United States, 78759
      • Velocity Clinical Research, Austin /ID# 233406
    • Beaumont, Texas, United States, 77706-3067
      • Tekton Research - Beaumont /ID# 238407
    • Dallas, Texas, United States, 75243
      • Relaro Medical Trials /ID# 241141
    • Dallas, Texas, United States, 75251-2202
      • Cedar Health Research /ID# 233403
    • El Paso, Texas, United States, 79925-7945
      • 3A Research - East El Paso /ID# 241665
    • Friendswood, Texas, United States, 77546
      • Earle Research /ID# 238940
    • Houston, Texas, United States, 77065
      • DM Clinical Research /ID# 238361
    • Houston, Texas, United States, 77090-2633
      • Houston Clinical Research Associates /ID# 246522
    • Kerrville, Texas, United States, 78028-9640
      • Sante Clinical Research /ID# 248333
    • Lampasas, Texas, United States, 76550
      • FMC Science /ID# 240475
    • Mansfield, Texas, United States, 76063-5622
      • Livingspring Family Medical Center /ID# 252194
    • Plano, Texas, United States, 75093
      • AIM Trials /ID# 233425
    • San Antonio, Texas, United States, 78249-3538
      • Road Runner Research /ID# 238360
    • The Woodlands, Texas, United States, 77381
      • Family Psychiatry of The Woodlands /ID# 238980
    • Waxahachie, Texas, United States, 75165-1430
      • ClinPoint Trials /ID# 238406
  • Utah
    • Bountiful, Utah, United States, 84010-4968
      • Pantheon Clinical Research /ID# 251475
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research /ID# 240053
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Health Hospital /ID# 239021
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
  • Virginia
    • Franklin, Virginia, United States, 23851
      • Office of Maria Ona /ID# 239833
    • Norfolk, Virginia, United States, 23507-1901
      • Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
    • Richmond, Virginia, United States, 23294
      • National Clinical Research /ID# 238419
  • Washington
    • Everett, Washington, United States, 98201
      • Core Clinical Research /ID# 233421
  • West Virginia
    • Kingwood, West Virginia, United States, 26537-9797
      • Frontier Clinical Research - Kingwood /ID# 238459
  • Wisconsin
    • Mequon, Wisconsin, United States, 53092
      • Mind+ Neurology /ID# 275538

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ubrogepant Dose A (12 to 17 Years Old); 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.	Drug: Ubrogepant; Oral Tablet; Other Names: Ubrelvy
Experimental: Ubrogepant Dose B (6 to 11 Years Old); 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.	Drug: Ubrogepant; Oral Tablet; Other Names: Ubrelvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Migraine; Ubrogepant; Ubrelvy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 3110-306-002

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; CSR

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