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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)

NCT ID: NCT05125302
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: AbbVie
Conditions: Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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)

Enrollment: 1059 participants (Estimated).

What is being studied

Drug: Placebo-Matching Ubrogepant
Intervention: ubrogepant
Drug: Ubrogepant

Who may be eligible

Ages: 6 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

129 study locations are listed.

Recruiting site status is explicitly provided for 129 locations; 91 are listed as Recruiting.

Countries: Puerto Rico, United States

Alabama, United States: 2
Arizona, United States: 1
Arkansas, United States: 3
California, United States: 12
Colorado, United States: 4
Connecticut, United States: 1
District of Columbia, United States: 1
Florida, United States: 18
Georgia, United States: 7
Idaho, United States: 1
Illinois, United States: 2
Iowa, United States: 1
Kansas, United States: 4
Kentucky, United States: 1
Maryland, United States: 1
Minnesota, United States: 1
Mississippi, United States: 2
Missouri, United States: 1
Nebraska, United States: 1
New Hampshire, United States: 1
New Jersey, United States: 3
New York, United States: 5
North Carolina, United States: 3
Ohio, United States: 6
Oklahoma, United States: 1
Oregon, United States: 1
Pennsylvania, United States: 3
South Carolina, United States: 3
Tennessee, United States: 1
Texas, United States: 22

Sample of listed locations

Puerto Rico Health Institute /ID# 249162 — Dorado, 00646, Puerto Rico — Recruiting
Caribbean Medical Research Center Headlands /ID# 265301 — San Juan, 00918-3501, Puerto Rico — Recruiting
GCM Medical Group /ID# 249643 — San Juan, 00917-3104, Puerto Rico — Recruiting
Rehabilitation & Neurological Services /ID# 229969 — Huntsville, Alabama, 35805-4046, United States — Recruiting
The Center for Clinical Trials - Saraland /ID# 231546 — Saraland, Alabama, 36571, United States — Recruiting
Velocity Clinical Research - Phoenix /ID# 274478 — Phoenix, Arizona, 85006, United States — Recruiting
HealthStar Research Glenwood /ID# 275303 — Glenwood, Arkansas, 71943, United States — Recruiting
HealthStar Research of Hot Springs /ID# 273256 — Hot Springs, Arkansas, 71913, United States — Recruiting
Preferred Research Partners /ID# 230725 — Little Rock, Arkansas, 72211, United States — Recruiting
Advanced Research Center /ID# 227962 — Anaheim, California, 92805, United States — Recruiting
Neuro Pain Research Center /ID# 227966 — Fresno, California, 93710, United States — Recruiting
Imax Clinical Trials /ID# 281436 — La Palma, California, 90623, United States — Recruiting
Alliance for Research Alliance for Wellness /ID# 230546 — Long Beach, California, 90807, United States — Recruiting
Paradigm Clinical Research - Modesto, CA /ID# 280611 — Modesto, California, 95355, United States — Recruiting
Excell Research, Inc /ID# 230899 — Oceanside, California, 92056, United States — Recruiting
Paradigm Clinical Research - San Diego /ID# 269608 — San Diego, California, 92108-1681, United States — Recruiting
Lumos Clinical Research Center /ID# 231267 — San Jose, California, 95124-4108, United States — Recruiting
Sunwise Clinical Research /ID# 230971 — Walnut Creek, California, 94596, United States — Recruiting
Amicis Research Center /ID# 272621 — Winnetka, California, 91306, United States — Recruiting
Children's Hospital Colorado - Aurora /ID# 231879 — Aurora, Colorado, 80045, United States — Recruiting
Paradigm Clinical Research - Aurora, CO /ID# 280612 — Aurora, Colorado, 80012, United States — Recruiting
New England Institute for Clinical Research /ID# 230635 — Stamford, Connecticut, 06905, United States — Recruiting
Emerson Clinical Research Institute - Connecticut Avenue - Washington /ID# 231693 — Washington D.C., District of Columbia, 20009, United States — Recruiting
Encore Medical Research of Boynton Beach LLC /ID# 246833 — Boynton Beach, Florida, 33436-7245, United States — Recruiting
Gulf Coast Clinical Research Center /ID# 230020 — Fort Myers, Florida, 33912, United States — Recruiting

Study details

Start date: January 13, 2022
Primary completion date: May 1, 2027
Completion date: May 1, 2027
First posted: November 18, 2021

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05125302
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT05125302 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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