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RECRUITING

NCT05125302

PHASE3

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)

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

1059

Start Date

2022-01-13

Completion Date

2026-05

Last Updated

2026-03-04

Healthy Volunteers

Conditions

Migraine

Interventions

DRUG

Ubrogepant

Oral Tablet

DRUG

Placebo-Matching Ubrogepant

Oral Tablet

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

Locations (124)

Rehabilitation & Neurological Services /ID# 229969

Huntsville, Alabama, United States

The Center for Clinical Trials - Saraland /ID# 231546

Saraland, Alabama, United States

Velocity Clinical Research - Phoenix /ID# 274478

Phoenix, Arizona, United States

HealthStar Research Glenwood /ID# 275303

Glenwood, Arkansas, United States

HealthStar Research of Hot Springs PLLC /ID# 273256

Hot Springs, Arkansas, United States

Preferred Research Partners /ID# 230725

Little Rock, Arkansas, United States

Advanced Research Center /ID# 227962

Anaheim, California, United States

Neuro Pain Research Center /ID# 227966

Fresno, California, United States

Alliance for Research Alliance for Wellness /ID# 230546

Long Beach, California, United States

Children's Hospital Los Angeles /ID# 230596

Los Angeles, California, United States

Excell Research, Inc /ID# 230899

Oceanside, California, United States

Paradigm Clinical Research - San Diego /ID# 269608

San Diego, California, United States

Lumos Clinical Research Center /ID# 231267

San Jose, California, United States

Pacific Clinical Research Management Group /ID# 231636

Upland, California, United States

Sunwise Clinical Research /ID# 230971

Walnut Creek, California, United States

Amicis Research Center /ID# 272621

Winnetka, California, United States

Children's Hospital Colorado - Aurora /ID# 231879

Aurora, Colorado, United States

IMMUNOe Research Centers /ID# 230879

Centennial, Colorado, United States

MCB Clinical Research Centers /ID# 231625

Colorado Springs, Colorado, United States

New England Institute for Clinical Research /ID# 230635

Stamford, Connecticut, United States

Emerson Clinical Research Institute - Washington - Connecticut Avenue /ID# 231693

Washington D.C., District of Columbia, United States

Encore Medical Research of Boynton Beach LLC /ID# 246833

Boynton Beach, Florida, United States

Gulf Coast Clinical Research Center /ID# 230020

Fort Myers, Florida, United States

Sarkis Clinical Trials /ID# 227956

Gainesville, Florida, United States

Northwest Florida Clinical Research Group, LLC /ID# 231069

Gulf Breeze, Florida, United States

AGA Clinical Trials /ID# 230554

Hialeah, Florida, United States

Encore Medical Research /ID# 245682

Hollywood, Florida, United States

Advanced Research Institute of Miami /ID# 230292

Homestead, Florida, United States

Auzmer Research /ID# 239251

Lakeland, Florida, United States

Columbus Clinical Services, Llc /Id# 230880

Miami, Florida, United States

My Preferred Research LLC /ID# 227886

Miami, Florida, United States

Neurology & Pain Medicine /ID# 240168

Miami, Florida, United States

Medical Research Group of Central Florida /ID# 231632

Orange City, Florida, United States

Clinical Associates of Orlando, LLC /ID# 272619

Orlando, Florida, United States

Suncoast Clinical Research - Palm Harbor /ID# 229337

Palm Harbor, Florida, United States

Asclepes Research Centers - Spring Hill /ID# 229815

Spring Hill, Florida, United States

University of South Florida- Neuroscience Institute /ID# 229324

Tampa, Florida, United States

Encore Medical Research - Weston /ID# 246809

Weston, Florida, United States

Pediatric Neurology and Epilepsy Specialists /ID# 229967

Winter Park, Florida, United States

Treken Primary Care /ID# 240586

Atlanta, Georgia, United States

Rare Disease Research, LLC /ID# 231046

Atlanta, Georgia, United States

Clinical Integrative Research Center of Atlanta (CIRCA) /ID# 231134

Atlanta, Georgia, United States

Coastal Georgia Child Neurology /ID# 231409

Brunswick, Georgia, United States

CenExcel iResearch LLC /ID# 227903

Decatur, Georgia, United States

Velocity Clinical Research - Savannah. /ID# 228992

Savannah, Georgia, United States

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738

Stockbridge, Georgia, United States

Velocity Clinical Research - Boise /ID# 231871

Meridian, Idaho, United States

Chicago Headache Center & Research Institute /ID# 248625

Chicago, Illinois, United States

Ascension Saint Alexius /ID# 275261

Hoffman Estates, Illinois, United States

Accellacare - McFarland Clinic /ID# 229789

Ames, Iowa, United States

College Park Family Care Center Overland Park /ID# 231456

Overland Park, Kansas, United States

Clinical Associates Midwest, LLC /ID# 274315

Overland Park, Kansas, United States

Psychiatric Associates /ID# 230872

Overland Park, Kansas, United States

Alliance for Multispecialty Research - Wichita East /ID# 234126

Wichita, Kansas, United States

University of Kentucky Chandler Medical Center. /ID# 230827

Lexington, Kentucky, United States

Pharmasite Research, Inc. /ID# 227908

Baltimore, Maryland, United States

Minneapolis Clinic of Neurology - Burnsville /ID# 232551

Burnsville, Minnesota, United States

MediSync Clinical Research Hattiesburg Clinic /ID# 233326

Petal, Mississippi, United States

Proven Endpoints LLC /ID# 239513

Ridgeland, Mississippi, United States

Sharlin Health and Neurology /ID# 229523

Ozark, Missouri, United States

Cognitive Clinical Trials (CCT) - Papillion /ID# 232552

Papillion, Nebraska, United States

Healthy Perspectives - Innovative Mental Health Services, PLLC /ID# 230312

Nashua, New Hampshire, United States

Hunterdon Neurology /ID# 245648

Annandale, New Jersey, United States

Goryeb Childrens Hospital /ID# 229507

Morristown, New Jersey, United States

CVS HealthHUB - Runnemede /ID# 234233

Runnemede, New Jersey, United States

Dent Neurologic Institute - Amherst /ID# 231182

Amherst, New York, United States

Bioscience Research /ID# 232159

Mount Kisco, New York, United States

Modern Migraine MD /ID# 258081

New York, New York, United States

North Suffolk Neurology /ID# 230956

Port Jefferson Station, New York, United States

SUNY Upstate Medical University /ID# 239898

Syracuse, New York, United States

CVS HealthHUB - Charlotte /ID# 239530

Charlotte, North Carolina, United States

OnSite Clinical Solutions, LLC - Hickory /ID# 227994

Hickory, North Carolina, United States

Patient Priority Clinical Sites, LLC /ID# 238485

Cincinnati, Ohio, United States

University Of Cincinnati Medical Center /ID# 231199

Cincinnati, Ohio, United States

Cincinnati Childrens Hospital Medical Center /ID# 244689

Cincinnati, Ohio, United States

Headache Center of Hope /ID# 242645

Cincinnati, Ohio, United States

Centricity Research Columbus /ID# 231181

Columbus, Ohio, United States

CincyScience /ID# 230046

West Chester, Ohio, United States

IPS Research Company /ID# 227961

Oklahoma City, Oklahoma, United States

Providence Brain and Spine Institute /ID# 231607

Portland, Oregon, United States

Children's Hospital of Philadelphia - Main /ID# 232487

Philadelphia, Pennsylvania, United States

Frontier Clinical Research, LLC - Scottdale /ID# 231913

Scottdale, Pennsylvania, United States

Frontier Clinical Research - Smithfield /ID# 231912

Smithfield, Pennsylvania, United States

Coastal Pediatric Research /ID# 238616

Charleston, South Carolina, United States

Tribe Clinical Research LLC /ID# 230422

Greenville, South Carolina, United States

Duplicate_Premier Neurology, P.C. /ID# 227999

Greer, South Carolina, United States

Access Clinical Trials, Inc. /ID# 228002

Nashville, Tennessee, United States

UT Health Austin at Dell Children's Neurology Clinic /ID# 244266

Austin, Texas, United States

Austin Regional Clinic - ARC Four Points /ID# 276301

Austin, Texas, United States

BioBehavioral Research of Austin /ID# 230529

Austin, Texas, United States

Velocity Clinical Research, Austin /ID# 230557

Austin, Texas, United States

Tekton Research - Beaumont /ID# 231207

Beaumont, Texas, United States

Relaro Medical Trials /ID# 239642

Dallas, Texas, United States

Cedar Health Research /ID# 228003

Dallas, Texas, United States

Epic Medical Research - DeSoto /ID# 274314

DeSoto, Texas, United States

3A Research - East El Paso /ID# 239193

El Paso, Texas, United States

Earle Research /ID# 231548

Friendswood, Texas, United States

Innovare Research Group, LLC /ID# 277617

Friendswood, Texas, United States

DM Clinical Research /ID# 229826

Houston, Texas, United States

Aavon Clinical Trials /ID# 279007

Houston, Texas, United States

Houston Clinical Research Associates /ID# 244889

Houston, Texas, United States

Pioneer Research Solutions - Houston - Stancliff Road /ID# 274316

Houston, Texas, United States

Sante Clinical Research /ID# 246503

Kerrville, Texas, United States

FMC Science /ID# 231915

Lampasas, Texas, United States

Livingspring Family Medical Center /ID# 249869

Mansfield, Texas, United States

AIM Trials /ID# 230142

Plano, Texas, United States

Road Runner Research /ID# 230527

San Antonio, Texas, United States

Family Psychiatry of The Woodlands /ID# 230163

The Woodlands, Texas, United States

ClinPoint Trials /ID# 230295

Waxahachie, Texas, United States

Pantheon Clinical Research /ID# 250703

Bountiful, Utah, United States

Highland Clinical Research /ID# 239362

Salt Lake City, Utah, United States

University of Utah Health Hospital /ID# 230908

Salt Lake City, Utah, United States

Neuropsychiatric Associates LLC/DBA Woodstock Research Center /ID# 238976

Woodstock, Vermont, United States

Office of Maria Ona /ID# 234232

Franklin, Virginia, United States

Children's Hospital of The King's Daughters - Children's Medical Tower /ID# 230581

Norfolk, Virginia, United States

National Clinical Research /ID# 231320

Richmond, Virginia, United States

Core Clinical Research /ID# 227904

Everett, Washington, United States

MultiCare Institute for Research & Innovation /ID# 231061

Tacoma, Washington, United States

Frontier Clinical Research - Kingwood /ID# 231914

Kingwood, West Virginia, United States

Mind+ Neurology /ID# 275529

Mequon, Wisconsin, United States

Clinical Research Investigator Group, LLC /ID# 267454

Bayamón, Puerto Rico

Puerto Rico Health Institute /ID# 249162

Dorado, Puerto Rico

GCM Medical Group PSC /ID# 249643

San Juan, Puerto Rico

CMRC Headlands LLC /ID# 265301

San Juan, Puerto Rico

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (124)