Ubrogepant: Oral Tablet
Placebo-Matching Ubrogepant: Oral Tablet
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 how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents.
Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment.
For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months.
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 effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
| Facility | City | Region | Status |
|---|---|---|---|
| Rehabilitation & Neurological Services /ID# 229969 | Huntsville | Alabama | Recruiting |
| The Center for Clinical Trials - Saraland /ID# 231546 | Saraland | Alabama | Recruiting |
| Velocity Clinical Research - Phoenix /ID# 274478 | Phoenix | Arizona | Recruiting |
| HealthStar Research Glenwood /ID# 275303 | Glenwood | Arkansas | Recruiting |
| HealthStar Research of Hot Springs /ID# 273256 | Hot Springs | Arkansas | Recruiting |
| Preferred Research Partners /ID# 230725 | Little Rock | Arkansas | Recruiting |
| Advanced Research Center /ID# 227962 | Anaheim | California | Recruiting |
| Neuro Pain Research Center /ID# 227966 | Fresno | California | Recruiting |
| Imax Clinical Trials /ID# 281436 | La Palma | California | Recruiting |
| Alliance for Research Alliance for Wellness /ID# 230546 | Long Beach | California | Recruiting |
| Children's Hospital Los Angeles /ID# 230596 | Los Angeles | California | Completed |
| Paradigm Clinical Research - Modesto, CA /ID# 280611 | Modesto | California | Recruiting |
| Excell Research, Inc /ID# 230899 | Oceanside | California | Recruiting |
| Paradigm Clinical Research - San Diego /ID# 269608 | San Diego | California | Recruiting |
| Lumos Clinical Research Center /ID# 231267 | San Jose | California | Recruiting |
| Pacific Clinical Research Management Group /ID# 231636 | Upland | California | Completed |
| Sunwise Clinical Research /ID# 230971 | Walnut Creek | California | Recruiting |
| Amicis Research Center /ID# 272621 | Winnetka | California | Recruiting |
| Paradigm Clinical Research - Aurora, CO /ID# 280612 | Aurora | Colorado | Recruiting |
| Children's Hospital Colorado - Aurora /ID# 231879 | Aurora | Colorado | Recruiting |
| IMMUNOe Research Centers /ID# 230879 | Centennial | Colorado | Completed |
| MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625 | Colorado Springs | Colorado | Completed |
| New England Institute for Clinical Research /ID# 230635 | Stamford | Connecticut | Recruiting |
| Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693 | Washington D.C. | District of Columbia | Recruiting |
| Encore Medical Research of Boynton Beach LLC /ID# 246833 | Boynton Beach | Florida | Recruiting |
| Gulf Coast Clinical Research Center /ID# 230020 | Fort Myers | Florida | Recruiting |
| Sarkis Clinical Trials /ID# 227956 | Gainesville | Florida | Completed |
| Northwest Florida Clinical Research Group, LLC /ID# 231069 | Gulf Breeze | Florida | Completed |
| AGA Clinical Trials /ID# 230554 | Hialeah | Florida | Recruiting |
| Encore Medical Research /ID# 245682 | Hollywood | Florida | Recruiting |
| Advanced Research Institute of Miami /ID# 230292 | Homestead | Florida | Completed |
| Auzmer Research /ID# 239251 | Lakeland | Florida | Completed |
| Columbus Clinical Services, Llc /Id# 230880 | Miami | Florida | Recruiting |
| My Preferred Research LLC /ID# 227886 | Miami | Florida | Recruiting |
| Neurology & Pain Medicine /ID# 240168 | Miami | Florida | Completed |
| Medical Research Group of Central Florida /ID# 231632 | Orange City | Florida | Recruiting |
| Clinical Associates of Orlando, LLC /ID# 272619 | Orlando | Florida | Recruiting |
| Suncoast Clinical Research - Palm Harbor /ID# 229337 | Palm Harbor | Florida | Completed |
| FWD Clinical Research - Spring Hill /ID# 229815 | Spring Hill | Florida | Recruiting |
| University of South Florida- Neuroscience Institute /ID# 229324 | Tampa | Florida | Recruiting |
+ 89 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05125302 on ClinicalTrials.gov ↗ ← All trials in the USA