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Enrolling by invitationPhase 3

Long-term safety of ubrogepant for migraine in children and teens

Tests ubrogepant tablets for migraine attacks over the long term in children aged 6-17.

Plain-language title generated from the registry record
Registry title: 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)

Key facts

Where
Ames, Amherst, Anaheim, Annandale, Atlanta, Aurora, Austin, Baltimore, Beaumont, Bountiful, Boynton Beach, Brunswick, Burnsville, Centennial, Charleston, Charlotte, Chicago, Cincinnati, Colorado Springs, Columbus, Dallas, Decatur, El Paso, Everett, Fort Myers, Franklin, Fresno, Friendswood, Gainesville, Greenville, Greer, Gulf Breeze, Hialeah, Hickory, Hollywood, Homestead, Houston, Huntsville, Kerrville, Kingwood, Lakeland, Lampasas, Lexington, Little Rock, Long Beach, Los Angeles, Mansfield, Mequon, Meridian, Miami, Morristown, Mount Kisco, Nashua, Nashville, New York, Norfolk, Oceanside, Oklahoma City, Orange City, Orlando, Overland Park, Ozark, Palm Harbor, Papillion, Petal, Philadelphia, Plano, Port Jefferson Station, Portland, Richmond, Ridgeland, Runnemede, Salt Lake City, San Antonio, San Diego, San Jose, Saraland, Savannah, Scottdale, Smithfield, Spring Hill, Stamford, Stockbridge, Syracuse, Tampa, The Woodlands, Upland, Walnut Creek, Washington D.C., Waxahachie, West Chester, Weston, Wichita, Winter Park, and Woodstock, United StatesSee the 109 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Source: NCT05127954, who can take part

Where in United States

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
AbbVie
Trial code
NCT05127954
Record updated
20 July 2025
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT05127954