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Clinical Trials in the USA / NCT05125302
Recruiting Phase 3

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)

NCT05125302 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 3
Started
2022-01-13
Last updated
2026-09-14

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

UbrogepantPlacebo-Matching Ubrogepant

Ubrogepant: Oral Tablet

Placebo-Matching Ubrogepant: Oral Tablet

Study 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 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (129)

FacilityCityRegionStatus
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.

On this site

📄 Ubrelvy (ubrogepant) drug profile →

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Official registry record

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