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NCT05125302PHASE3Recruiting

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)

AbbVie

Start Date

1/13/2022

Completion Date

5/1/2027

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 Criteria

Age Range: 6 years to 17 years

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

Interventions

DRUG

Ubrogepant

DRUG

Placebo-Matching Ubrogepant

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Conditions

Migraine

Locations

Rehabilitation & Neurological Services /ID# 229969

Huntsville, Alabama 35805-4046

United States

The Center for Clinical Trials - Saraland /ID# 231546

Saraland, Alabama 36571

United States

Rezen Clinical Trials /ID# 282831

Glendale, Arizona 85306

United States

Velocity Clinical Research - Phoenix /ID# 274478

Phoenix, Arizona 85006

United States

HealthStar Research Glenwood /ID# 275303

Glenwood, Arkansas 71943

United States

HealthStar Research of Hot Springs /ID# 273256

Hot Springs, Arkansas 71913

United States

Preferred Research Partners /ID# 230725

Little Rock, Arkansas 72211

United States

Advanced Research Center /ID# 227962

Anaheim, California 92805

United States

Neuro Pain Research Center /ID# 227966

Fresno, California 93710

United States

Alliance for Research Alliance for Wellness /ID# 230546

Long Beach, California 90807

United States

Children's Hospital Los Angeles /ID# 230596

Los Angeles, California 90027

United States

Excell Research, Inc /ID# 230899

Oceanside, California 92056

United States

Paradigm Clinical Research - San Diego /ID# 269608

San Diego, California 92108-1681

United States

Lumos Clinical Research Center /ID# 231267

San Jose, California 95124-4108

United States

Pacific Clinical Research Management Group /ID# 231636

Upland, California 91786

United States

Sunwise Clinical Research /ID# 230971

Walnut Creek, California 94596

United States

Amicis Research Center /ID# 272621

Winnetka, California 91306

United States

Children's Hospital Colorado - Aurora /ID# 231879

Aurora, Colorado 80045

United States

IMMUNOe Research Centers /ID# 230879

Centennial, Colorado 80112

United States

MCB Clinical Research Centers - Colorado Springs - South Parkside Drive /ID# 231625

Colorado Springs, Colorado 80910

United States

New England Institute for Clinical Research /ID# 230635

Stamford, Connecticut 06905

United States

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

Washington D.C., District of Columbia 20009

United States

Encore Medical Research of Boynton Beach LLC /ID# 246833

Boynton Beach, Florida 33436-7245

United States

Gulf Coast Clinical Research Center /ID# 230020

Fort Myers, Florida 33912

United States

Sarkis Clinical Trials /ID# 227956

Gainesville, Florida 32607

United States

Northwest Florida Clinical Research Group, LLC /ID# 231069

Gulf Breeze, Florida 32561-4495

United States

AGA Clinical Trials /ID# 230554

Hialeah, Florida 33012

United States

Encore Medical Research /ID# 245682

Hollywood, Florida 33021

United States

Advanced Research Institute of Miami /ID# 230292

Homestead, Florida 33030-4613

United States

Auzmer Research /ID# 239251

Lakeland, Florida 33813-2768

United States

Columbus Clinical Services, Llc /Id# 230880

Miami, Florida 33125

United States

My Preferred Research LLC /ID# 227886

Miami, Florida 33155

United States

Neurology & Pain Medicine /ID# 240168

Miami, Florida 33186-7661

United States

Medical Research Group of Central Florida /ID# 231632

Orange City, Florida 32763

United States

Clinical Associates of Orlando, LLC /ID# 272619

Orlando, Florida 32819

United States

Suncoast Clinical Research - Palm Harbor /ID# 229337

Palm Harbor, Florida 34684

United States

FWD Clinical Research - Spring Hill /ID# 229815

Spring Hill, Florida 34609-5692

United States

University of South Florida- Neuroscience Institute /ID# 229324

Tampa, Florida 33613

United States

Encore Medical Research - Weston /ID# 246809

Weston, Florida 33331

United States

Pediatric Neurology and Epilepsy Specialists /ID# 229967

Winter Park, Florida 32789-7111

United States

Treken Primary Care /ID# 240586

Atlanta, Georgia 30315

United States

Rare Disease Research /ID# 231046

Atlanta, Georgia 30318-2512

United States

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

Atlanta, Georgia 30328

United States

Coastal Georgia Child Neurology /ID# 231409

Brunswick, Georgia 31520-1601

United States

CenExcel iResearch LLC /ID# 227903

Decatur, Georgia 30030

United States

Velocity Clinical Research - Savannah. /ID# 228992

Savannah, Georgia 31406

United States

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

Stockbridge, Georgia 30281

United States

Velocity Clinical Research - Boise /ID# 231871

Meridian, Idaho 83642

United States

Chicago Headache Center & Research Institute /ID# 248625

Chicago, Illinois 60657

United States

Ascension Saint Alexius /ID# 275261

Hoffman Estates, Illinois 60169

United States

Accellacare - McFarland Clinic /ID# 229789

Ames, Iowa 50010

United States

MercyOne Northeast Iowa Family Medicine & Residency /ID# 282810

Waterloo, Iowa 50702

United States

College Park Family Care Center Overland Park /ID# 231456

Overland Park, Kansas 66210-2761

United States

Clinical Associates Midwest, LLC /ID# 274315

Overland Park, Kansas 66214

United States

Psychiatric Associates /ID# 230872

Overland Park, Kansas 66221

United States

Alliance For Multispeciality Research - Wichita East /ID# 234126

Wichita, Kansas 67207

United States

University of Kentucky Chandler Medical Center /ID# 230827

Lexington, Kentucky 40536

United States

Pharmasite Research, Inc. /ID# 227908

Baltimore, Maryland 21208

United States

Minneapolis Clinic of Neurology - Burnsville /ID# 232551

Burnsville, Minnesota 55337-6732

United States

MediSync Clinical Research Hattiesburg Clinic /ID# 233326

Petal, Mississippi 39465-2932

United States

Proven Endpoints LLC /ID# 239513

Ridgeland, Mississippi 39157

United States

Sharlin Health and Neurology /ID# 229523

Ozark, Missouri 65721

United States

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

Papillion, Nebraska 68046-4131

United States

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

Nashua, New Hampshire 03060-3483

United States

Hunterdon Neurology /ID# 245648

Annandale, New Jersey 08801-3127

United States

Goryeb Childrens Hospital /ID# 229507

Morristown, New Jersey 07960

United States

CVS HealthHUB - Runnemede /ID# 234233

Runnemede, New Jersey 08078-1034

United States

Dent Neurologic Institute - Amherst /ID# 231182

Amherst, New York 14226

United States

Duplicate_Bioscience Research /ID# 232159

Mount Kisco, New York 10549-3028

United States

Modern Migraine MD /ID# 258081

New York, New York 10001

United States

North Suffolk Neurology /ID# 230956

Port Jefferson Station, New York 11776-3387

United States

Hawthorne Health - Staten Island /ID# 283144

Staten Island, New York 10309

United States

SUNY Upstate Medical University /ID# 239898

Syracuse, New York 13210

United States

CVS HealthHUB - Charlotte /ID# 239530

Charlotte, North Carolina 28210-8905

United States

OnSite Clinical Solutions - Ninth Ave Drive North East - Hickory /ID# 227994

Hickory, North Carolina 28601

United States

Patient Priority Clinical Sites, LLC /ID# 238485

Cincinnati, Ohio 45215-2123

United States

University Of Cincinnati Medical Center /ID# 231199

Cincinnati, Ohio 45219

United States

Cincinnati Childrens Hospital Medical Center /ID# 244689

Cincinnati, Ohio 45229

United States

Headache Center of Hope /ID# 242645

Cincinnati, Ohio 45236-1875

United States

Centricity Research Columbus /ID# 231181

Columbus, Ohio 43213

United States

CincyScience /ID# 230046

West Chester, Ohio 45069

United States

IPS Research Company /ID# 227961

Oklahoma City, Oklahoma 73106

United States

Providence Brain and Spine Institute /ID# 231607

Portland, Oregon 97225-6625

United States

Hawthorne Health - Horsham /ID# 283151

Horsham, Pennsylvania 19044

United States

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

Philadelphia, Pennsylvania 19104-4319

United States

Frontier Clinical Research - Scottdale /ID# 231913

Scottdale, Pennsylvania 15683

United States

Frontier Clinical Research - Smithfield /ID# 231912

Smithfield, Pennsylvania 15478

United States

Coastal Pediatric Research /ID# 238616

Charleston, South Carolina 29414-5834

United States

Tribe Clinical Research LLC /ID# 230422

Greenville, South Carolina 29607-4021

United States

Duplicate_Premier Neurology, P.C. /ID# 227999

Greer, South Carolina 29650

United States

Hawthorne Health - Lebanon /ID# 283149

Lebanon, Tennessee 37087

United States

Access Clinical Trials, Inc. /ID# 228002

Nashville, Tennessee 37203

United States

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

Austin, Texas 78723-3079

United States

Austin Regional Clinic - ARC Four Points /ID# 276301

Austin, Texas 78726

United States

BioBehavioral Research of Austin /ID# 230529

Austin, Texas 78759

United States

Velocity Clinical Research, Austin /ID# 230557

Austin, Texas 78759

United States

Tekton Research - Beaumont /ID# 231207

Beaumont, Texas 77706-3067

United States

Relaro Medical Trials /ID# 239642

Dallas, Texas 75243

United States

Cedar Health Research /ID# 228003

Dallas, Texas 75251-2202

United States

Epic Medical Research - DeSoto /ID# 274314

DeSoto, Texas 75115

United States

3A Research - East El Paso /ID# 239193

El Paso, Texas 79925-7945

United States

Earle Research /ID# 231548

Friendswood, Texas 77546

United States

Innovare Research Group, LLC /ID# 277617

Friendswood, Texas 77546

United States

DM Clinical Research /ID# 229826

Houston, Texas 77065

United States

Aavon Clinical Trials /ID# 279007

Houston, Texas 77074

United States

Houston Clinical Research Associates /ID# 244889

Houston, Texas 77090-2633

United States

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

Houston, Texas 77099

United States

Sante Clinical Research /ID# 246503

Kerrville, Texas 78028-9640

United States

FMC Science /ID# 231915

Lampasas, Texas 76550

United States

Livingspring Family Medical Center /ID# 249869

Mansfield, Texas 76063-5622

United States

AIM Trials /ID# 230142

Plano, Texas 75093

United States

Road Runner Research /ID# 230527

San Antonio, Texas 78249-3538

United States

Family Psychiatry of The Woodlands /ID# 230163

The Woodlands, Texas 77381

United States

ClinPoint Trials /ID# 230295

Waxahachie, Texas 75165-1430

United States

Pantheon Clinical Research /ID# 250703

Bountiful, Utah 84010-4968

United States

Highland Clinical Research /ID# 239362

Salt Lake City, Utah 84124

United States

University of Utah Health Hospital /ID# 230908

Salt Lake City, Utah 84132

United States

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

Woodstock, Vermont 05091

United States

Office of Maria Ona /ID# 234232

Franklin, Virginia 23851

United States

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

Norfolk, Virginia 23507-1901

United States

National Clinical Research /ID# 231320

Richmond, Virginia 23294

United States

Core Clinical Research /ID# 227904

Everett, Washington 98201

United States

MultiCare Institute for Research and Innovation /ID# 231061

Tacoma, Washington 98405

United States

Frontier Clinical Research - Kingwood /ID# 231914

Kingwood, West Virginia 26537-9797

United States

Mind+ Neurology /ID# 275529

Mequon, Wisconsin 53092

United States

Clinical Research Investigator Group /ID# 267454

Bayamón, 00960

Puerto Rico

Puerto Rico Health Institute /ID# 249162

Dorado, 00646

Puerto Rico

GCM Medical Group /ID# 249643

San Juan, 00917-3104

Puerto Rico

Caribbean Medical Research Center Headlands /ID# 265301

San Juan, 00918-3501

Puerto Rico