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)
Public ClinicalTrials.gov record NCT05127954. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05127954
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 14, 2022 (Actual)
- Primary completion
- Jan 2028 (Estimated)
- Completion
- Jan 2028 (Estimated)
- Last update posted
- Jul 20, 2025
2022 – 2028
United States locations
- U.S. sites
- 109
- U.S. states
- 35
- U.S. cities
- 95
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rehabilitation & Neurological Services /ID# 240054 | Huntsville | Alabama | 35805-4046 | — |
| The Center for Clinical Trials - Saraland /ID# 239448 | Saraland | Alabama | 36571 | — |
| Preferred Research Partners /ID# 238979 | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center /ID# 238967 | Anaheim | California | 92805 | — |
| Neuro Pain Medical Center /ID# 239135 | Fresno | California | 93710 | — |
| Alliance for Research Alliance for Wellness /ID# 233497 | Long Beach | California | 90807 | — |
| Children's Hospital Los Angeles /ID# 239446 | Los Angeles | California | 90027 | — |
| Excell Research, Inc /ID# 233495 | Oceanside | California | 92056 | — |
| Paradigm Clinical Research - San Diego /ID# 269611 | San Diego | California | 92108-1681 | — |
| Lumos Clinical Research Center /ID# 239018 | San Jose | California | 95124-4108 | — |
| Pacific Clinical Research Management Group /ID# 238503 | Upland | California | 91786 | — |
| Sunwise Clinical Research /ID# 238458 | Walnut Creek | California | 94596 | — |
| Children's Hospital Colorado - Aurora /ID# 239838 | Aurora | Colorado | 80045 | — |
| IMMUNOe Research Centers /ID# 240846 | Centennial | Colorado | 80112 | — |
| MCB Clinical Research Centers /ID# 240999 | Colorado Springs | Colorado | 80910 | — |
| New England Institute for Clinical Research /ID# 239019 | Stamford | Connecticut | 06905 | — |
| Emerson Clinical Research Inst /ID# 238455 | Washington D.C. | District of Columbia | 20011 | — |
| Encore Medical Research of Boynton Beach LLC /ID# 248720 | Boynton Beach | Florida | 33436-7245 | — |
| Gulf Coast Clinical Research Center /ID# 233335 | Fort Myers | Florida | 33912 | — |
| Sarkis Clinical Trials /ID# 233493 | Gainesville | Florida | 32607 | — |
| Northwest Florida Clinical Research Group, LLC /ID# 244396 | Gulf Breeze | Florida | 32561-4495 | — |
| A.G.A Clinical Trials /ID# 238409 | Hialeah | Florida | 33012 | — |
| Encore Medical Research /ID# 247463 | Hollywood | Florida | 33021 | — |
| Advanced Research Institute of Miami /ID# 240712 | Homestead | Florida | 33030-4613 | — |
| Auzmer Research /ID# 241514 | Lakeland | Florida | 33813-2768 | — |
| 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 | — |
| Medical Research Group of Central Florida /ID# 240711 | Orange City | Florida | 32763 | — |
| Clinical Associates of Orlando, LLC /ID# 272623 | Orlando | Florida | 32819 | — |
| Suncoast Clinical Research - Palm Harbor /ID# 233535 | Palm Harbor | Florida | 34684 | — |
| Asclepes Research Centers - Spring Hill /ID# 231872 | Spring Hill | Florida | 34609-5692 | — |
| University of South Florida- Neuroscience Institute /ID# 233420 | Tampa | Florida | 33613 | — |
| Encore Medical Research - Weston /ID# 248335 | Weston | Florida | 33331 | — |
| Pediatric Neurology and Epilepsy Specialists /ID# 233336 | Winter Park | Florida | 32789-7111 | — |
| 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 | — |
| Coastal Georgia Child Neurology /ID# 240845 | Brunswick | Georgia | 31520-1601 | — |
| CenExcel iResearch LLC /ID# 239832 | Decatur | Georgia | 30030 | — |
| Velocity Clinical Research - Savannah /ID# 231873 | Savannah | Georgia | 31406 | — |
| Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 238454 | Stockbridge | Georgia | 30281 | — |
| Velocity Clinical Research - Boise /ID# 238978 | Meridian | Idaho | 83642 | — |
| Chicago Headache Center & Research Institute /ID# 254071 | Chicago | Illinois | 60657 | — |
| Accellacare - McFarland Clinic /ID# 238490 | Ames | Iowa | 50010 | — |
| 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 | — |
| Alliance for Multispecialty Research (AMR) - Wichita West /ID# 239829 | Wichita | Kansas | 67205-1138 | — |
| University of Kentucky Chandler Medical Center /ID# 233428 | Lexington | Kentucky | 40536 | — |
| Pharmasite Research, Inc. /ID# 233414 | Baltimore | Maryland | 21208 | — |
| Minneapolis Clinic of Neurology - Burnsville /ID# 238828 | Burnsville | Minnesota | 55337-6732 | — |
| MediSync Clinical Research Hattiesburg Clinic /ID# 239837 | Petal | Mississippi | 39465-2932 | — |
| Proven Endpoints LLC /ID# 240974 | Ridgeland | Mississippi | 39157 | — |
| Sharlin Health Neuroscience Research Center /ID# 238969 | Ozark | Missouri | 65721-5315 | — |
| Cognitive Clinical Trials (CCT) - Papillion /ID# 239835 | Papillion | Nebraska | 68046-4131 | — |
| Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 239441 | Nashua | New Hampshire | 03060-3483 | — |
| Hunterdon Neurology /ID# 248222 | Annandale | New Jersey | 08801-3127 | — |
| Goryeb Children's Hospital /ID# 239425 | Morristown | New Jersey | 07960 | — |
| CVS HealthHUB - Runnemede /ID# 240057 | Runnemede | New Jersey | 08078-1034 | — |
| Dent Neurologic Institute - Amherst /ID# 238415 | Amherst | New York | 14226 | — |
| Bioscience Research /ID# 239442 | Mount Kisco | New York | 10549-3028 | — |
| Modern Migraine MD /ID# 263140 | New York | New York | 10001 | — |
| North Suffolk Neurology /ID# 238457 | Port Jefferson Station | New York | 11776-3387 | — |
| SUNY Upstate Medical University /ID# 241140 | Syracuse | New York | 13210 | — |
| CVS HealthHUB - Charlotte /ID# 240842 | Charlotte | North Carolina | 28210-8905 | — |
| OnSite Clinical Solutions, LLC - Hickory /ID# 238946 | Hickory | North Carolina | 28601 | — |
| 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 | — |
| Centricity Research Columbus /ID# 238832 | Columbus | Ohio | 43213 | — |
| CincyScience /ID# 233334 | West Chester | Ohio | 45069 | — |
| IPS Research Company /ID# 231876 | Oklahoma City | Oklahoma | 73106 | — |
| Providence Brain and Spine Institute /ID# 240050 | Portland | Oregon | 97225-6625 | — |
| Children's Hospital of Philadelphia - Main /ID# 241138 | Philadelphia | Pennsylvania | 19104-4319 | — |
| Frontier Clinical Research, LLC - Scottdale /ID# 239017 | Scottdale | Pennsylvania | 15683 | — |
| Frontier Clinical Research - Smithfield /ID# 238502 | Smithfield | Pennsylvania | 15478 | — |
| Coastal Pediatric Research /ID# 240708 | Charleston | South Carolina | 29414-5834 | — |
| Tribe Clinical Research LLC /ID# 239143 | Greenville | South Carolina | 29607-4021 | — |
| Duplicate_Premier Neurology, P.C. /ID# 233419 | Greer | South Carolina | 29650 | — |
| Access Clinical Trials, Inc. /ID# 238414 | Nashville | Tennessee | 37203 | — |
| 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 | — |
| Tekton Research - Beaumont /ID# 238407 | Beaumont | Texas | 77706-3067 | — |
| Relaro Medical Trials /ID# 241141 | Dallas | Texas | 75243 | — |
| Cedar Health Research /ID# 233403 | Dallas | Texas | 75251-2202 | — |
| 3A Research - East El Paso /ID# 241665 | El Paso | Texas | 79925-7945 | — |
| Earle Research /ID# 238940 | Friendswood | Texas | 77546 | — |
| DM Clinical Research /ID# 238361 | Houston | Texas | 77065 | — |
| Houston Clinical Research Associates /ID# 246522 | Houston | Texas | 77090-2633 | — |
| Sante Clinical Research /ID# 248333 | Kerrville | Texas | 78028-9640 | — |
| FMC Science /ID# 240475 | Lampasas | Texas | 76550 | — |
| Livingspring Family Medical Center /ID# 252194 | Mansfield | Texas | 76063-5622 | — |
| AIM Trials /ID# 233425 | Plano | Texas | 75093 | — |
| Road Runner Research /ID# 238360 | San Antonio | Texas | 78249-3538 | — |
| Family Psychiatry of The Woodlands /ID# 238980 | The Woodlands | Texas | 77381 | — |
| ClinPoint Trials /ID# 238406 | Waxahachie | Texas | 75165-1430 | — |
| Pantheon Clinical Research /ID# 251475 | Bountiful | Utah | 84010-4968 | — |
| Highland Clinical Research /ID# 240053 | Salt Lake City | Utah | 84124 | — |
| University of Utah Health Hospital /ID# 239021 | Salt Lake City | Utah | 84132 | — |
| Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 240055 | Woodstock | Vermont | 05091 | — |
| Office of Maria Ona /ID# 239833 | Franklin | Virginia | 23851 | — |
| Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 239142 | Norfolk | Virginia | 23507-1901 | — |
| National Clinical Research /ID# 238419 | Richmond | Virginia | 23294 | — |
| Core Clinical Research /ID# 233421 | Everett | Washington | 98201 | — |
| Frontier Clinical Research - Kingwood /ID# 238459 | Kingwood | West Virginia | 26537-9797 | — |
| Mind+ Neurology /ID# 275538 | Mequon | Wisconsin | 53092 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05127954, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2025 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05127954 live on ClinicalTrials.gov.