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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)
Sponsor: AbbVie
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.
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)
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2022-01-14
Completion Date
2028-01
Last Updated
2025-07-20
Healthy Volunteers
No
Conditions
Interventions
Ubrogepant
Oral Tablet
Locations (113)
Rehabilitation & Neurological Services /ID# 240054
Huntsville, Alabama, United States
The Center for Clinical Trials - Saraland /ID# 239448
Saraland, Alabama, United States
Preferred Research Partners /ID# 238979
Little Rock, Arkansas, United States
Advanced Research Center /ID# 238967
Anaheim, California, United States
Neuro Pain Medical Center /ID# 239135
Fresno, California, United States
Alliance for Research Alliance for Wellness /ID# 233497
Long Beach, California, United States
Children's Hospital Los Angeles /ID# 239446
Los Angeles, California, United States
Excell Research, Inc /ID# 233495
Oceanside, California, United States
Paradigm Clinical Research - San Diego /ID# 269611
San Diego, California, United States
Lumos Clinical Research Center /ID# 239018
San Jose, California, United States
Pacific Clinical Research Management Group /ID# 238503
Upland, California, United States
Sunwise Clinical Research /ID# 238458
Walnut Creek, California, United States
Children's Hospital Colorado - Aurora /ID# 239838
Aurora, Colorado, United States
IMMUNOe Research Centers /ID# 240846
Centennial, Colorado, United States
MCB Clinical Research Centers /ID# 240999
Colorado Springs, Colorado, United States
New England Institute for Clinical Research /ID# 239019
Stamford, Connecticut, United States
Emerson Clinical Research Inst /ID# 238455
Washington D.C., District of Columbia, United States
Encore Medical Research of Boynton Beach LLC /ID# 248720
Boynton Beach, Florida, United States
Gulf Coast Clinical Research Center /ID# 233335
Fort Myers, Florida, United States
Sarkis Clinical Trials /ID# 233493
Gainesville, Florida, United States
Northwest Florida Clinical Research Group, LLC /ID# 244396
Gulf Breeze, Florida, United States
A.G.A Clinical Trials /ID# 238409
Hialeah, Florida, United States
Encore Medical Research /ID# 247463
Hollywood, Florida, United States
Advanced Research Institute of Miami /ID# 240712
Homestead, Florida, United States
Auzmer Research /ID# 241514
Lakeland, Florida, United States
Columbus Clinical Services, Llc /Id# 238968
Miami, Florida, United States
My Preferred Research LLC /ID# 239020
Miami, Florida, United States
Neurology & Pain Medicine /ID# 241860
Miami, Florida, United States
Medical Research Group of Central Florida /ID# 240711
Orange City, Florida, United States
Clinical Associates of Orlando, LLC /ID# 272623
Orlando, Florida, United States
Suncoast Clinical Research - Palm Harbor /ID# 233535
Palm Harbor, Florida, United States
Asclepes Research Centers - Spring Hill /ID# 231872
Spring Hill, Florida, United States
University of South Florida- Neuroscience Institute /ID# 233420
Tampa, Florida, United States
Encore Medical Research - Weston /ID# 248335
Weston, Florida, United States
Pediatric Neurology and Epilepsy Specialists /ID# 233336
Winter Park, Florida, United States
Global Research Associates /ID# 243504
Atlanta, Georgia, United States
Rare Disease Research, LLC /ID# 238833
Atlanta, Georgia, United States
Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 238852
Atlanta, Georgia, United States
Coastal Georgia Child Neurology /ID# 240845
Brunswick, Georgia, United States
CenExcel iResearch LLC /ID# 239832
Decatur, Georgia, United States
Velocity Clinical Research - Savannah /ID# 231873
Savannah, Georgia, United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454
Stockbridge, Georgia, United States
Velocity Clinical Research - Boise /ID# 238978
Meridian, Idaho, United States
Chicago Headache Center & Research Institute /ID# 254071
Chicago, Illinois, United States
Accellacare - McFarland Clinic /ID# 238490
Ames, Iowa, United States
College Park Family Care Center Overland Park /ID# 240707
Overland Park, Kansas, United States
Clinical Associates Midwest, LLC /ID# 274356
Overland Park, Kansas, United States
Psychiatric Associates /ID# 240710
Overland Park, Kansas, United States
Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829
Wichita, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 233428
Lexington, Kentucky, United States
Pharmasite Research, Inc. /ID# 233414
Baltimore, Maryland, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 238828
Burnsville, Minnesota, United States
MediSync Clinical Research Hattiesburg Clinic /ID# 239837
Petal, Mississippi, United States
Proven Endpoints LLC /ID# 240974
Ridgeland, Mississippi, United States
Sharlin Health Neuroscience Research Center /ID# 238969
Ozark, Missouri, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 239835
Papillion, Nebraska, United States
Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441
Nashua, New Hampshire, United States
Hunterdon Neurology /ID# 248222
Annandale, New Jersey, United States
Goryeb Children's Hospital /ID# 239425
Morristown, New Jersey, United States
CVS HealthHUB - Runnemede /ID# 240057
Runnemede, New Jersey, United States
Dent Neurologic Institute - Amherst /ID# 238415
Amherst, New York, United States
Bioscience Research /ID# 239442
Mount Kisco, New York, United States
Modern Migraine MD /ID# 263140
New York, New York, United States
North Suffolk Neurology /ID# 238457
Port Jefferson Station, New York, United States
SUNY Upstate Medical University /ID# 241140
Syracuse, New York, United States
CVS HealthHUB - Charlotte /ID# 240842
Charlotte, North Carolina, United States
OnSite Clinical Solutions, LLC - Hickory /ID# 238946
Hickory, North Carolina, United States
Patient Priority Clinical Sites, LLC /ID# 240051
Cincinnati, Ohio, United States
University of Cincinnati /ID# 238461
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center /ID# 247491
Cincinnati, Ohio, United States
Headache Center of Hope /ID# 244819
Cincinnati, Ohio, United States
Centricity Research Columbus /ID# 238832
Columbus, Ohio, United States
CincyScience /ID# 233334
West Chester, Ohio, United States
IPS Research Company /ID# 231876
Oklahoma City, Oklahoma, United States
Providence Brain and Spine Institute /ID# 240050
Portland, Oregon, United States
Children's Hospital of Philadelphia - Main /ID# 241138
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC - Scottdale /ID# 239017
Scottdale, Pennsylvania, United States
Frontier Clinical Research - Smithfield /ID# 238502
Smithfield, Pennsylvania, United States
Coastal Pediatric Research /ID# 240708
Charleston, South Carolina, United States
Tribe Clinical Research LLC /ID# 239143
Greenville, South Carolina, United States
Duplicate_Premier Neurology, P.C. /ID# 233419
Greer, South Carolina, United States
Access Clinical Trials, Inc. /ID# 238414
Nashville, Tennessee, United States
UT Health Austin at Dell Children's Neurology Clinic /ID# 246570
Austin, Texas, United States
BioBehavioral Research of Austin /ID# 233427
Austin, Texas, United States
Velocity Clinical Research, Austin /ID# 233406
Austin, Texas, United States
Tekton Research - Beaumont /ID# 238407
Beaumont, Texas, United States
Relaro Medical Trials /ID# 241141
Dallas, Texas, United States
Cedar Health Research /ID# 233403
Dallas, Texas, United States
3A Research - East El Paso /ID# 241665
El Paso, Texas, United States
Earle Research /ID# 238940
Friendswood, Texas, United States
DM Clinical Research /ID# 238361
Houston, Texas, United States
Houston Clinical Research Associates /ID# 246522
Houston, Texas, United States
Sante Clinical Research /ID# 248333
Kerrville, Texas, United States
FMC Science /ID# 240475
Lampasas, Texas, United States
Livingspring Family Medical Center /ID# 252194
Mansfield, Texas, United States
AIM Trials /ID# 233425
Plano, Texas, United States
Road Runner Research /ID# 238360
San Antonio, Texas, United States
Family Psychiatry of The Woodlands /ID# 238980
The Woodlands, Texas, United States
ClinPoint Trials /ID# 238406
Waxahachie, Texas, United States
Pantheon Clinical Research /ID# 251475
Bountiful, Utah, United States
Highland Clinical Research /ID# 240053
Salt Lake City, Utah, United States
University of Utah Health Hospital /ID# 239021
Salt Lake City, Utah, United States
Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055
Woodstock, Vermont, United States
Office of Maria Ona /ID# 239833
Franklin, Virginia, United States
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142
Norfolk, Virginia, United States
National Clinical Research /ID# 238419
Richmond, Virginia, United States
Core Clinical Research /ID# 233421
Everett, Washington, United States
Frontier Clinical Research - Kingwood /ID# 238459
Kingwood, West Virginia, United States
Mind+ Neurology /ID# 275538
Mequon, Wisconsin, United States
Clinical Research Investigator Group, LLC /ID# 267458
Bayamón, Puerto Rico
Puerto Rico Health Institute /ID# 250560
Dorado, Puerto Rico
GCM Medical Group PSC /ID# 250561
San Juan, Puerto Rico
Caribbean Medical Research Center /ID# 265292
San Juan, Puerto Rico