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Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)

RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)

Who can join

Ages 6 to 17 · All sexes

Full eligibility criteria
Inclusion Criteria:

* A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months.
* By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
* History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).
* Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the acute treatment of migraine.
* For main study participants, treatment of a qualifying migraine with single-blind placebo during the screening period and completion of 2-hour headache pain assessment.
* Weight is ≥ 20 kg (44 pounds) and \< 135 kg (298 pounds)
* Per investigator judgment, participant is able to swallow or can learn to swallow study intervention.
* The participant is able to understand and complete the study questionnaires and eDiary. Participants who need assistance with reading the assessments may be assisted by a parent or guardian.

Exclusion Criteria:

* Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
* In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, or other significant neurological disorders other than migraine.
* History of malignancy in the 5 years prior to Visit 1.
* History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of the study intervention.
* Significant risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others; participants must be excluded if they report suicidal ideation with intent, with or without a plan, (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the last 6 months prior to Visit 1 or Visit 2 assessments.
* At Visit 1, current alcohol or drug abuse or dependence per investigator's judgment.
* For main study participants, no headache at the 2-hour post dose assessment after taking single-blind placebo for a qualifying migraine during screening period (ie, placebo responder).
* A current diagnosis of chronic migraine as defined by ICHD-3
* Participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month or any combination of triptans, ergots, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 10 days/month in the 3 months prior to Visit 1 per investigator's judgment.
* Difficulty distinguishing migraine headache from tension-type or other headaches.
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
* Required in-hospital (excluding emergency department visits) treatment for migraines 3 or more times in the 6 months prior to Visit 1.
* 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.
* Previous exposure, within the last 6 months, to injectable monoclonal antibodies blocking the calcitonin gene-related peptide (CGRP) pathway
* History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist or hypersensitivity to any component of the study interventions, ubrogepant or placebo.
* Currently participating or has participated in a study with an investigational compound or device within 30 days prior to Visit 1

About the study

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.

What is being tested

Sponsor: AbbVie · Participants: 1,059 · Started: Jan 13, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05125302

Locations in the U.S.

AlabamaRehabilitation & Neurological Services /ID# 229969, Huntsville
The Center for Clinical Trials - Saraland /ID# 231546, Saraland
ArizonaVelocity Clinical Research - Phoenix /ID# 274478, Phoenix
ArkansasHealthStar Research Glenwood /ID# 275303, Glenwood
HealthStar Research of Hot Springs /ID# 273256, Hot Springs
Preferred Research Partners /ID# 230725, Little Rock
CaliforniaAdvanced Research Center /ID# 227962, Anaheim
Neuro Pain Research Center /ID# 227966, Fresno
Imax Clinical Trials /ID# 281436, La Palma
Alliance for Research Alliance for Wellness /ID# 230546, Long Beach
Paradigm Clinical Research - Modesto, CA /ID# 280611, Modesto
Excell Research, Inc /ID# 230899, Oceanside
Paradigm Clinical Research - San Diego /ID# 269608, San Diego
Lumos Clinical Research Center /ID# 231267, San Jose
Sunwise Clinical Research /ID# 230971, Walnut Creek
Amicis Research Center /ID# 272621, Winnetka
ColoradoChildren's Hospital Colorado - Aurora /ID# 231879, Aurora
Paradigm Clinical Research - Aurora, CO /ID# 280612, Aurora
ConnecticutNew England Institute for Clinical Research /ID# 230635, Stamford
District of ColumbiaEmerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693, Washington D.C.
FloridaEncore Medical Research of Boynton Beach LLC /ID# 246833, Boynton Beach
Gulf Coast Clinical Research Center /ID# 230020, Fort Myers
AGA Clinical Trials /ID# 230554, Hialeah
Encore Medical Research /ID# 245682, Hollywood
Columbus Clinical Services, Llc /Id# 230880, Miami
My Preferred Research LLC /ID# 227886, Miami
Medical Research Group of Central Florida /ID# 231632, Orange City
Clinical Associates of Orlando, LLC /ID# 272619, Orlando
FWD Clinical Research - Spring Hill /ID# 229815, Spring Hill
University of South Florida- Neuroscience Institute /ID# 229324, Tampa
Encore Medical Research - Weston /ID# 246809, Weston
Pediatric Neurology and Epilepsy Specialists /ID# 229967, Winter Park
GeorgiaClinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134, Atlanta
Rare Disease Research /ID# 231046, Atlanta
Coastal Georgia Child Neurology /ID# 231409, Brunswick
Velocity Clinical Research - Savannah. /ID# 228992, Savannah
IdahoVelocity Clinical Research - Boise /ID# 231871, Meridian
IllinoisChicago Headache Center & Research Institute /ID# 248625, Chicago
Ascension Saint Alexius /ID# 275261, Hoffman Estates
IowaAccellacare - McFarland Clinic /ID# 229789, Ames
KansasClinical Associates Midwest, LLC /ID# 274315, Overland Park
Alliance For Multispeciality Research - Wichita East /ID# 234126, Wichita
KentuckyUniversity of Kentucky Chandler Medical Center /ID# 230827, Lexington
MarylandPharmasite Research, Inc. /ID# 227908, Baltimore
MinnesotaMinneapolis Clinic of Neurology - Burnsville /ID# 232551, Burnsville
MississippiProven Endpoints LLC /ID# 239513, Ridgeland
NebraskaCognitive Clinical Trials (CCT) - Papillion /ID# 232552, Papillion
New HampshireHealthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312, Nashua
New JerseyGoryeb Childrens Hospital /ID# 229507, Morristown
New YorkDent Neurologic Institute - Amherst /ID# 231182, Amherst
SUNY Upstate Medical University /ID# 239898, Syracuse
North CarolinaOnsite Clinical Solutions - Don Lochman Lane - Charlotte /ID# 282834, Charlotte
OhioCincinnati Childrens Hospital Medical Center /ID# 244689, Cincinnati
Headache Center of Hope /ID# 242645, Cincinnati
Patient Priority Clinical Sites, LLC /ID# 238485, Cincinnati
University Of Cincinnati Medical Center /ID# 231199, Cincinnati
Centricity Research Columbus /ID# 231181, Columbus
CincyScience /ID# 230046, West Chester
OregonProvidence Brain and Spine Institute /ID# 231607, Portland
PennsylvaniaChildren's Hospital of Philadelphia - Main /ID# 232487, Philadelphia
Frontier Clinical Research - Scottdale /ID# 231913, Scottdale
Frontier Clinical Research - Smithfield /ID# 231912, Smithfield
South CarolinaTribe Clinical Research LLC /ID# 230422, Greenville
TennesseeAccess Clinical Trials, Inc. /ID# 228002, Nashville
TexasAustin Regional Clinic - ARC Four Points /ID# 276301, Austin
UT Health Austin at Dell Children's Neurology Clinic /ID# 244266, Austin
Velocity Clinical Research, Austin /ID# 230557, Austin
Cedar Health Research /ID# 228003, Dallas
Relaro Medical Trials /ID# 239642, Dallas
Epic Medical Research - DeSoto /ID# 274314, DeSoto
Innovare Research Group, LLC /ID# 277617, Friendswood
Aavon Clinical Trials /ID# 279007, Houston
DM Clinical Research /ID# 229826, Houston
Houston Clinical Research Associates /ID# 244889, Houston
Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316, Houston
Sante Clinical Research /ID# 246503, Kerrville
FMC Science /ID# 231915, Lampasas
Livingspring Family Medical Center /ID# 249869, Mansfield
Road Runner Research /ID# 230527, San Antonio
ClinPoint Trials /ID# 230295, Waxahachie
UtahPantheon Clinical Research /ID# 250703, Bountiful
Highland Clinical Research /ID# 239362, Salt Lake City
VirginiaPediatric Associates of Charlottesville, PLC /ID# 230628, Charlottesville
Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581, Norfolk
WashingtonCore Clinical Research /ID# 227904, Everett
MultiCare Institute for Research and Innovation /ID# 231061, Tacoma
West VirginiaFrontier Clinical Research - Kingwood /ID# 231914, Kingwood
WisconsinMind+ Neurology /ID# 275529, Mequon

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.